lenabasum profile

lenabasum: a CB2 cannabinoid receptor agonist; structure in first source [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

ID Source	ID
PubMed CID	3083542
CHEMBL ID	456341
SCHEMBL ID	26441
MeSH ID	M0446561

Synonym
ogn7x90bt8 ,
ab-iii-56
cpl 7075
ct 3
6h-dibenzo(b,d)pyran-9-carboxylic acid, 3-(1,1-dimethylheptyl)-6a,7,10,10a-tetrahydro-1-hydroxy-6,6-dimethyl-, (6ar,10ar)
lenabasum [usan]
6h-dibenzo(b,d)pyran-9-carboxylic acid, 3-(1,1-dimethylheptyl)-6a,7,10,10a-tetrahydro-1-hydroxy-6,6-dimethyl-, (6ar,10ar)-
unii-ogn7x90bt8
ip 751
(6ar,10ar)-1-hydroxy-6,6-dimethyl-3-(2-methyl-2-octanyl)-6a,7,8,10a-tetrahydro-6h-benzo(c)chromene-9-carboxylic acid
ip-751
dmh-thc-11-oic
ct-3
ajulemic acid
cpl-7075
AJA ,
(6ar,10ar)-3-(1,1-dimethylheptyl)-1-hydroxy-6,6-dimethyl-6a,7,10,10a-tetrahydro-6h-benzo[c]chromene-9-carboxylic acid
bdbm50005920
cpl7075
resunab
CHEMBL456341
lenabasum
jbt-101
hu-239
(6ar,10ar)-1-hydroxy-6,6-dimethyl-3-(2-methyloctan-2-yl)-6a,7,10,10a-tetrahydrobenzo[c]chromene-9-carboxylic acid
137945-48-3
SCHEMBL26441
lenabasum [inn]
(6ar, 10ar)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydro-cannabinol-9-carboxylic acid
(6ar, 10ar)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid
(6ar,10ar)-3-(1,1-dimethylheptyl)-1-hydroxy-6,6-dimethyl-6a,7,10,10a-tetrahydro-6h-benzo(c)chromene-9-carboxylic acid
ajulemic acid [mi]
lenabasum [who-dd]
6h-dibenzo(b,d)pyran-9-carboxylic acid, 3-(1,1-dimethylheptyl)-6a,7,10,10a-tetrahydro-1-hydroxy-6,6-dimethyl-, (6ar-trans)-
CS-0025624
HY-106346
gtpl9772
ip751
DB12193
ajulemic acid; ct-3; ip-751; 1',1'-dimethylheptyl-delta8-tetrahydrocannabinol-11-oic acid
DTXSID40900959
Q3604498
BCP15191
D11312
lenabasum (usan/inn)
A935712
EX-A3627
6h-dibenzo[b,d]pyran-9-carboxylic acid, 3-(1,1-dimethylheptyl)-6a,7,10,10a-tetrahydro-1-hydroxy-6,6-dimethyl-, (6ar,10ar)-
AKOS040747784

Excerpt	Reference	Relevance
"Lenabasum is a synthetic cannabinoid receptor type-2 (CB2) agonist able to exert potent anti-inflammatory effects, but its role on T cells remains unknown."	( Potent T cell-mediated anti-inflammatory role of the selective CB2 agonist lenabasum in multiple sclerosis. Atamas, SP; Boffa, L; Chintalacharuvu, SR; Chiurchiù, V; Evron, T; Mercuri, NB; Saracini, S; Tiberi, M, 2022)	2.39
"Lenabasum is a cannabinoid type 2 receptor (CB2R) reverse agonist that demonstrates anti-inflammatory effects in vivo and in vitro in dermatomyositis (DM) and is currently being investigated for therapeutic potential. "	( Cannabinoid type 2 receptor (CB2R) distribution in dermatomyositis skin and peripheral blood mononuclear cells (PBMCs) and in vivo effects of Lenabasum Bashir, MM; Bax, C; Chen, KL; Concha, JSS; Diaz, A; Grinnell, M; Li, Y; Maddukuri, S; Okawa, J; Patel, J; Ravishankar, A; Reddy, N; Werth, VP; White, B; Wysocka, M; Zeidi, M, 2022)	2.37
"Lenabasum is a cannabinoid receptor type 2 agonist that triggers the resolution of inflammation."	( Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: A Randomized Clinical Trial. Bashir, MM; Concha, JSS; Constantine, S; Dgetluck, N; Feng, R; Gebre, K; Haber, J; Hejazi, E; Jadoo, AS; Okawa, J; Pena, SM; Reddy, N; Werth, VP; White, B; Zeidi, M, 2022)	1.75
"Lenabasum is an oral synthetic cannabinoid receptor type 2 agonist previously shown to reduce the production of key airway pro-inflammatory cytokines known to play a role in cystic fibrosis (CF). "	( Anti-inflammatory effects of lenabasum, a cannabinoid receptor type 2 agonist, on macrophages from cystic fibrosis. Andersen, ISG; Begum, N; Evron, T; Fantino, E; Morshed, MM; Sly, PD; Tarique, AA; Tepper, MA; Zhang, G, 2020)	2.29
"Lenabasum is a cannabinoid type 2 receptor (CB2) agonist that resolves inflammation in a number of in vitro and in vivo models."	( Safety and efficacy of lenabasum in a phase 2 randomized, placebo-controlled trial in adults with cystic fibrosis. Chmiel, JF; Colombo, C; Conley, B; Constantine, S; Dgetluck, N; Dinh, Q; Downey, DG; Dozor, AJ; Elborn, JS; Flume, P; Mazurek, H; Rachel, M; Sapiejka, E; White, B, 2021)	1.65
"Lenabasum is a synthetic agonist of the cannabinoid receptor type 2 (CB2) with anti-inflammatory and antifibrotic properties. "	( A Physiologically Based Pharmacokinetic and Drug-Drug Interaction Model for the CB2 Agonist Lenabasum. Atamas, SP; Fu, Q; Jones, HM; Sun, G, 2021)	2.28
"Lenabasum is a CYP substrate, and the model predicted lenabasum clearance of 51% by CYP2C9, 37% by CYP2C8, and 12% by CYP3A4."	( A Physiologically Based Pharmacokinetic and Drug-Drug Interaction Model for the CB2 Agonist Lenabasum. Atamas, SP; Fu, Q; Jones, HM; Sun, G, 2021)	1.56

Excerpt	Reference	Relevance
"Lenabasum treatment was well tolerated and was associated with greater improvement in Cutaneous Dermatomyositis Disease Area and Severity Index activity and multiple efficacy outcomes."	( Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: A Randomized Clinical Trial. Bashir, MM; Concha, JSS; Constantine, S; Dgetluck, N; Feng, R; Gebre, K; Haber, J; Hejazi, E; Jadoo, AS; Okawa, J; Pena, SM; Reddy, N; Werth, VP; White, B; Zeidi, M, 2022)	2.47

Excerpt	Reference	Relevance
" A recently published randomized double-blind crossover clinical trial described the pain-reducing effects and side effect profile of AJA on 21 patients with chronic neuropathic pain."	( Pain measurements and side effect profile of the novel cannabinoid ajulemic acid. Burstein, S; Hoy, L; Karst, M; Salim, K; Schneider, U, 2005)	0.33
" Studies to date indicate a unique mechanism of action for AJA that may explain its lack of adverse side effects."	( Ajulemic acid (IP-751): synthesis, proof of principle, toxicity studies, and clinical trials. Burstein, S, 2005)	0.33
" No deaths or serious or severe adverse events (AE) were considered related to lenabasum."	( Safety and efficacy of lenabasum in a phase 2 randomized, placebo-controlled trial in adults with cystic fibrosis. Chmiel, JF; Colombo, C; Conley, B; Constantine, S; Dgetluck, N; Dinh, Q; Downey, DG; Dozor, AJ; Elborn, JS; Flume, P; Mazurek, H; Rachel, M; Sapiejka, E; White, B, 2021)	1.16
" No serious or severe adverse events were related to lenabasum, and no participants discontinued the study."	( Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: A Randomized Clinical Trial. Bashir, MM; Concha, JSS; Constantine, S; Dgetluck, N; Feng, R; Gebre, K; Haber, J; Hejazi, E; Jadoo, AS; Okawa, J; Pena, SM; Reddy, N; Werth, VP; White, B; Zeidi, M, 2022)	1.28
" No deaths or excess in serious or severe adverse events related to lenabasum were observed."	( Efficacy and Safety of Lenabasum, a Cannabinoid Type 2 Receptor Agonist, in a Phase 3 Randomized Trial in Diffuse Cutaneous Systemic Sclerosis. Bloom, BJ; Chung, L; Constantine, S; de Vries-Bouwstra, J; Denton, CP; Dgetluck, N; Dinh, Q; Distler, O; Finzel, S; Frech, TM; Furst, DE; Gordon, J; Hsu, V; Hummers, L; Jankowski, T; Jun, JB; Kafaja, S; Khanna, D; Kuwana, M; Lee, EB; Leszcyzński, P; Levy, Y; Litinsky, I; Matucci-Cerinic, M; Mayes, M; Sandorfi, N; Simms, RW; Spiera, R; Steen, V; Stevens, W; White, B, 2023)	1.46

Excerpt	Reference	Relevance
"Our model is a useful tool for predicting the pharmacokinetics of lenabasum and adjustments to its dosing in possible drug-drug interaction scenarios."	( A Physiologically Based Pharmacokinetic and Drug-Drug Interaction Model for the CB2 Agonist Lenabasum. Atamas, SP; Fu, Q; Jones, HM; Sun, G, 2021)	1.08

Excerpt	Relevance	Reference
"Our model is a useful tool for predicting the pharmacokinetics of lenabasum and adjustments to its dosing in possible drug-drug interaction scenarios."	( A Physiologically Based Pharmacokinetic and Drug-Drug Interaction Model for the CB2 Agonist Lenabasum. Atamas, SP; Fu, Q; Jones, HM; Sun, G, 2021)	1.08
"A multinational double-blind study was conducted in 365 dcSSc patients who were randomized and dosed 1:1:1 with lenabasum 20 mg, lenabasum 5 mg, or placebo, each twice daily and added to background treatments, including immunosuppressive therapies (IST)."	( Efficacy and Safety of Lenabasum, a Cannabinoid Type 2 Receptor Agonist, in a Phase 3 Randomized Trial in Diffuse Cutaneous Systemic Sclerosis. Bloom, BJ; Chung, L; Constantine, S; de Vries-Bouwstra, J; Denton, CP; Dgetluck, N; Dinh, Q; Distler, O; Finzel, S; Frech, TM; Furst, DE; Gordon, J; Hsu, V; Hummers, L; Jankowski, T; Jun, JB; Kafaja, S; Khanna, D; Kuwana, M; Lee, EB; Leszcyzński, P; Levy, Y; Litinsky, I; Matucci-Cerinic, M; Mayes, M; Sandorfi, N; Simms, RW; Spiera, R; Steen, V; Stevens, W; White, B, 2023)	1.43

Protein	Taxonomy	Measurement	Average	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
Cannabinoid receptor 1	Homo sapiens (human)	Ki	0.0190	0.0001	0.5077	9.6000	AID1127482; AID1140580
Cannabinoid receptor 2	Homo sapiens (human)	Ki	0.1705	0.0000	0.4156	10.0000	AID1127483
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Protein	Taxonomy	Measurement	Average	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
Cannabinoid receptor 1	Homo sapiens (human)	EC50 (µMol)	0.9270	0.0001	0.1275	2.2400	AID1127495
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Process	via Protein(s)	Taxonomy
positive regulation of acute inflammatory response to antigenic stimulus	Cannabinoid receptor 1	Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger	Cannabinoid receptor 1	Homo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathway	Cannabinoid receptor 1	Homo sapiens (human)
spermatogenesis	Cannabinoid receptor 1	Homo sapiens (human)
axonal fasciculation	Cannabinoid receptor 1	Homo sapiens (human)
response to nutrient	Cannabinoid receptor 1	Homo sapiens (human)
memory	Cannabinoid receptor 1	Homo sapiens (human)
positive regulation of neuron projection development	Cannabinoid receptor 1	Homo sapiens (human)
negative regulation of serotonin secretion	Cannabinoid receptor 1	Homo sapiens (human)
positive regulation of fever generation	Cannabinoid receptor 1	Homo sapiens (human)
negative regulation of fatty acid beta-oxidation	Cannabinoid receptor 1	Homo sapiens (human)
regulation of synaptic transmission, GABAergic	Cannabinoid receptor 1	Homo sapiens (human)
response to lipopolysaccharide	Cannabinoid receptor 1	Homo sapiens (human)
negative regulation of mast cell activation	Cannabinoid receptor 1	Homo sapiens (human)
negative regulation of dopamine secretion	Cannabinoid receptor 1	Homo sapiens (human)
response to nicotine	Cannabinoid receptor 1	Homo sapiens (human)
cannabinoid signaling pathway	Cannabinoid receptor 1	Homo sapiens (human)
response to cocaine	Cannabinoid receptor 1	Homo sapiens (human)
glucose homeostasis	Cannabinoid receptor 1	Homo sapiens (human)
positive regulation of apoptotic process	Cannabinoid receptor 1	Homo sapiens (human)
response to ethanol	Cannabinoid receptor 1	Homo sapiens (human)
negative regulation of action potential	Cannabinoid receptor 1	Homo sapiens (human)
negative regulation of blood pressure	Cannabinoid receptor 1	Homo sapiens (human)
positive regulation of blood pressure	Cannabinoid receptor 1	Homo sapiens (human)
regulation of insulin secretion	Cannabinoid receptor 1	Homo sapiens (human)
regulation of synaptic transmission, glutamatergic	Cannabinoid receptor 1	Homo sapiens (human)
maternal process involved in female pregnancy	Cannabinoid receptor 1	Homo sapiens (human)
regulation of feeding behavior	Cannabinoid receptor 1	Homo sapiens (human)
regulation of penile erection	Cannabinoid receptor 1	Homo sapiens (human)
retrograde trans-synaptic signaling by endocannabinoid	Cannabinoid receptor 1	Homo sapiens (human)
regulation of presynaptic cytosolic calcium ion concentration	Cannabinoid receptor 1	Homo sapiens (human)
trans-synaptic signaling by endocannabinoid, modulating synaptic transmission	Cannabinoid receptor 1	Homo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathway	Cannabinoid receptor 1	Homo sapiens (human)
regulation of metabolic process	Cannabinoid receptor 1	Homo sapiens (human)
response to amphetamine	Cannabinoid receptor 2	Homo sapiens (human)
inflammatory response	Cannabinoid receptor 2	Homo sapiens (human)
immune response	Cannabinoid receptor 2	Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger	Cannabinoid receptor 2	Homo sapiens (human)
leukocyte chemotaxis	Cannabinoid receptor 2	Homo sapiens (human)
negative regulation of synaptic transmission, GABAergic	Cannabinoid receptor 2	Homo sapiens (human)
response to lipopolysaccharide	Cannabinoid receptor 2	Homo sapiens (human)
negative regulation of mast cell activation	Cannabinoid receptor 2	Homo sapiens (human)
cannabinoid signaling pathway	Cannabinoid receptor 2	Homo sapiens (human)
negative regulation of action potential	Cannabinoid receptor 2	Homo sapiens (human)
regulation of metabolic process	Cannabinoid receptor 2	Homo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathway	Cannabinoid receptor 2	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
cannabinoid receptor activity	Cannabinoid receptor 1	Homo sapiens (human)
protein binding	Cannabinoid receptor 1	Homo sapiens (human)
identical protein binding	Cannabinoid receptor 1	Homo sapiens (human)
G protein-coupled receptor activity	Cannabinoid receptor 1	Homo sapiens (human)
protein binding	Cannabinoid receptor 2	Homo sapiens (human)
cannabinoid receptor activity	Cannabinoid receptor 2	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
mitochondrial outer membrane	Cannabinoid receptor 1	Homo sapiens (human)
plasma membrane	Cannabinoid receptor 1	Homo sapiens (human)
actin cytoskeleton	Cannabinoid receptor 1	Homo sapiens (human)
growth cone	Cannabinoid receptor 1	Homo sapiens (human)
presynaptic membrane	Cannabinoid receptor 1	Homo sapiens (human)
membrane raft	Cannabinoid receptor 1	Homo sapiens (human)
glutamatergic synapse	Cannabinoid receptor 1	Homo sapiens (human)
GABA-ergic synapse	Cannabinoid receptor 1	Homo sapiens (human)
plasma membrane	Cannabinoid receptor 1	Homo sapiens (human)
cytoplasm	Cannabinoid receptor 1	Homo sapiens (human)
plasma membrane	Cannabinoid receptor 2	Homo sapiens (human)
dendrite	Cannabinoid receptor 2	Homo sapiens (human)
extrinsic component of cytoplasmic side of plasma membrane	Cannabinoid receptor 2	Homo sapiens (human)
perikaryon	Cannabinoid receptor 2	Homo sapiens (human)
endoplasmic reticulum	Cannabinoid receptor 2	Homo sapiens (human)
plasma membrane	Cannabinoid receptor 2	Homo sapiens (human)
cytoplasm	Cannabinoid receptor 2	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (30)

Assay ID	Title	Year	Journal	Article
AID1140594	Drug metabolism in human hepatocytes assessed as parent compound remaining after 2 hrs	2014	Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10	The cannabinoid acids, analogs and endogenous counterparts.
AID1154063	Antinociceptive activity in CD1 mouse assessed as increase in paw withdrawal latency at 0.05 to 5 mg/kg, po measured after 90 mins post dose by hot plate test relative to vehicle-treated control	2014	Bioorganic & medicinal chemistry, Jul-01, Volume: 22, Issue:13	Ultrapure ajulemic acid has improved CB2 selectivity with reduced CB1 activity.
AID1140592	Drug metabolism in dog hepatocytes assessed as parent compound remaining after 2 hrs	2014	Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10	The cannabinoid acids, analogs and endogenous counterparts.
AID1140586	Induction of LXA4 production in human blood at 1 to 30 uM incubated for 5 hrs by ELISA	2014	Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10	The cannabinoid acids, analogs and endogenous counterparts.
AID1140580	Binding affinity to CB1 receptor (unknown origin)	2014	Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10	The cannabinoid acids, analogs and endogenous counterparts.
AID1140579	Reversal of PAF-induced allodynia in ip dosed rat after 40 to 60 mins by paw withdrawal test	2014	Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10	The cannabinoid acids, analogs and endogenous counterparts.
AID387957	Antiproliferative activity against human HTB126 cells assessed as fluorescence units at 10 uM after 24 hrs by luciferase assay	2008	Bioorganic & medicinal chemistry, Nov-15, Volume: 16, Issue:22	Acylamido analogs of endocannabinoids selectively inhibit cancer cell proliferation.
AID387959	Antiproliferative activity against human HTB126 cells assessed as fluorescence units at 10 uM after 72 hrs by luciferase assay	2008	Bioorganic & medicinal chemistry, Nov-15, Volume: 16, Issue:22	Acylamido analogs of endocannabinoids selectively inhibit cancer cell proliferation.
AID1127484	Selectivity ratio of Ki for human CB1 receptor to Ki for human CB2 receptor	2013	Journal of medicinal chemistry, Nov-14, Volume: 56, Issue:21	Therapeutic utility of cannabinoid receptor type 2 (CB(2)) selective agonists.
AID387960	Antiproliferative activity against human HTB126 cells assessed as fluorescence units at 10 uM after 96 hrs by luciferase assay	2008	Bioorganic & medicinal chemistry, Nov-15, Volume: 16, Issue:22	Acylamido analogs of endocannabinoids selectively inhibit cancer cell proliferation.
AID1140590	Plasma concentration in patient at 20 mg, po after 2 hrs	2014	Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10	The cannabinoid acids, analogs and endogenous counterparts.
AID1127482	Binding affinity to human CB1 receptor	2013	Journal of medicinal chemistry, Nov-14, Volume: 56, Issue:21	Therapeutic utility of cannabinoid receptor type 2 (CB(2)) selective agonists.
AID387966	Antiproliferative activity against human HeLa cells at 10 uM after 48 hrs relative to control	2008	Bioorganic & medicinal chemistry, Nov-15, Volume: 16, Issue:22	Acylamido analogs of endocannabinoids selectively inhibit cancer cell proliferation.
AID1140578	Analgesic activity in rat assessed as reversal of mechanical hyperalgesia at 0.1 to 1 mg/kg, po	2014	Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10	The cannabinoid acids, analogs and endogenous counterparts.
AID646683	Ratio of drug uptake in brain to plasma of Sprague-Dawley rat at 1 mg/kg, sc	2012	Bioorganic & medicinal chemistry letters, Feb-15, Volume: 22, Issue:4	γ-Carbolines: a novel class of cannabinoid agonists with high aqueous solubility and restricted CNS penetration.
AID1140591	Drug metabolism in rat hepatocytes assessed as parent compound remaining after 2 hrs	2014	Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10	The cannabinoid acids, analogs and endogenous counterparts.
AID1127483	Binding affinity to human CB2 receptor	2013	Journal of medicinal chemistry, Nov-14, Volume: 56, Issue:21	Therapeutic utility of cannabinoid receptor type 2 (CB(2)) selective agonists.
AID1140582	Antiinflammatory activity in mouse assessed as reduction of IL-1beta/TNF-alpha-induced leukocyte count in air pouches at 0.2 mg/kg/day	2014	Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10	The cannabinoid acids, analogs and endogenous counterparts.
AID1140589	Induction of LXA4 production in human blood at 25 uM after 1 hr in presence of 12/15 LOX inhibitor baicalein relative to control	2014	Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10	The cannabinoid acids, analogs and endogenous counterparts.
AID1140584	Inhibition of MMP-3 release in TNF alpha-induced HFLS cells at 10 uM	2014	Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10	The cannabinoid acids, analogs and endogenous counterparts.
AID1127495	Agonist activity at CB1 receptor (unknown origin) assessed as cAMP production	2013	Journal of medicinal chemistry, Nov-14, Volume: 56, Issue:21	Therapeutic utility of cannabinoid receptor type 2 (CB(2)) selective agonists.
AID1140588	Induction of LXA4 production in zymosan-A-induced FVB mouse peritonitis model at 1.5 mg/kg, iv by mass spectrometry relative to control	2014	Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10	The cannabinoid acids, analogs and endogenous counterparts.
AID1140585	Induction of LXA4 production in HFLS cells at 1 to 30 uM incubated for 1 hr followed by TNF-alpha challenge for 18 hrs by ELISA relative to control	2014	Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10	The cannabinoid acids, analogs and endogenous counterparts.
AID1140583	Antiinflammatory activity in mouse assessed as adhering leukocytes at 1 mg/kg, po after 6 hrs relative to vehicle-treated control	2014	Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10	The cannabinoid acids, analogs and endogenous counterparts.
AID1140581	Antiinflammatory activity in mouse assessed as reduction of IL-1beta/TNF-alpha-induced leukocyte count in air pouches at 0.1 mg/kg/day	2014	Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10	The cannabinoid acids, analogs and endogenous counterparts.
AID1140587	Reduction of cell invasion to peritoneum in zymosan-A-induced FVB mouse peritonitis model at 1.5 mg/kg, iv by mass spectrometry	2014	Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10	The cannabinoid acids, analogs and endogenous counterparts.
AID387958	Antiproliferative activity against human HTB126 cells assessed as fluorescence units at 10 uM after 48 hrs by luciferase assay	2008	Bioorganic & medicinal chemistry, Nov-15, Volume: 16, Issue:22	Acylamido analogs of endocannabinoids selectively inhibit cancer cell proliferation.
AID1140593	Drug metabolism in cynomolgus monkey hepatocytes assessed as parent compound remaining after 2 hrs	2014	Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10	The cannabinoid acids, analogs and endogenous counterparts.
AID1346701	Human CB1 receptor (Cannabinoid receptors)	2013	Journal of medicinal chemistry, Nov-14, Volume: 56, Issue:21	Therapeutic utility of cannabinoid receptor type 2 (CB(2)) selective agonists.
AID1346728	Human CB2 receptor (Cannabinoid receptors)	2013	Journal of medicinal chemistry, Nov-14, Volume: 56, Issue:21	Therapeutic utility of cannabinoid receptor type 2 (CB(2)) selective agonists.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	25 (52.08)	29.6817
2010's	11 (22.92)	24.3611
2020's	12 (25.00)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	8 (16.67%)	5.53%
Reviews	10 (20.83%)	6.00%
Case Studies	0 (0.00%)	4.05%
Observational	0 (0.00%)	0.25%
Other	30 (62.50%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (6)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus [NCT03093402]	Phase 2	109 participants (Actual)	Interventional	2017-12-21	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis [NCT03451045]	Phase 2	447 participants (Actual)	Interventional	2017-12-22	Completed
A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis [NCT02466243]	Phase 2	22 participants (Actual)	Interventional	2015-06-30	Terminated(stopped due to Sponsor terminated open-label extension.)
A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis [NCT02465450]	Phase 2	85 participants (Actual)	Interventional	2015-09-29	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis [NCT03813160]	Phase 3	176 participants (Actual)	Interventional	2018-12-17	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis [NCT03398837]	Phase 3	365 participants (Actual)	Interventional	2017-12-18	Terminated(stopped due to Sponsor terminated open-label extension)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT02465450 (2) [back to overview]	Number of Participants With Treatment Emergent Adverse Events.
NCT02465450 (2) [back to overview]	JBT-101 (Lenabasum) Plasma Concentrations on Day 84
NCT02466243 (2) [back to overview]	Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) From Baseline in Part A.
NCT02466243 (2) [back to overview]	Change in Patient-reported Outcomes From Baseline at 84 Days for Part A
NCT03093402 (38) [back to overview]	Percentage of Participants Indicating Clinical Benefit in Treatment Satisfaction
NCT03093402 (38) [back to overview]	Percentage of Participants With Improvement From Baseline in Arthritis in BILAG-2004
NCT03093402 (38) [back to overview]	Percentage of Physicians Indicating Participant Clinical Benefit in Treatment Satisfaction
NCT03093402 (38) [back to overview]	Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score
NCT03093402 (38) [back to overview]	Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score
NCT03093402 (38) [back to overview]	Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score
NCT03093402 (38) [back to overview]	Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score
NCT03093402 (38) [back to overview]	Change From Baseline in Physician Assessed Swollen Joint Count
NCT03093402 (38) [back to overview]	Change From Baseline in Physician Assessed Tender Joint Count
NCT03093402 (38) [back to overview]	Change in Baseline in PROMIS - Anxiety T-Score
NCT03093402 (38) [back to overview]	Change in Baseline in PROMIS - Depression T-Score
NCT03093402 (38) [back to overview]	Change in Baseline in PROMIS - Fatigue T-Score
NCT03093402 (38) [back to overview]	Change in Baseline in PROMIS - Pain Intensity
NCT03093402 (38) [back to overview]	Change in Baseline in PROMIS - Pain Interference T-Score
NCT03093402 (38) [back to overview]	Change in Baseline in PROMIS - Sleep Disturbance T-Score
NCT03093402 (38) [back to overview]	Change in Baseline in PROMIS - Social Role Satisfaction T-Score
NCT03093402 (38) [back to overview]	Change in Baseline in PROMIS Cognitive Function T-Score
NCT03093402 (38) [back to overview]	Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score
NCT03093402 (38) [back to overview]	Improvement in the Maximum Daily NRS-Pain Score at Day 84
NCT03093402 (38) [back to overview]	Number of BILAG-2004 Disease Flares
NCT03093402 (38) [back to overview]	Number of BILAG-2004 Disease Flares
NCT03093402 (38) [back to overview]	Number of BILAG-2004 Disease Flares
NCT03093402 (38) [back to overview]	Number of BILAG-2004 Disease Flares
NCT03093402 (38) [back to overview]	Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
NCT03093402 (38) [back to overview]	Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
NCT03093402 (38) [back to overview]	Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
NCT03093402 (38) [back to overview]	Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
NCT03093402 (38) [back to overview]	Percentage of Participants as Responders Using the SLE Responder Index (SRI)
NCT03093402 (38) [back to overview]	Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
NCT03093402 (38) [back to overview]	Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
NCT03093402 (38) [back to overview]	Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
NCT03093402 (38) [back to overview]	Number of Grade 3 or Higher Treatment-emergent Adverse Events (TEAE) Related to Study Product
NCT03093402 (38) [back to overview]	Percentage of Participants With Increased Scores From Baseline on ARCI-M
NCT03093402 (38) [back to overview]	Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI
NCT03093402 (38) [back to overview]	Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score
NCT03093402 (38) [back to overview]	Number of Treatment Emergent Events With Elevated Liver Tests
NCT03093402 (38) [back to overview]	Number of Treatment Emergent Intolerability Events
NCT03093402 (38) [back to overview]	Number of Treatment Emergent QTc Prolongation Events
NCT03451045 (6) [back to overview]	Pulmonary Exacerbation (PEx) Rate Over 28 Weeks
NCT03451045 (6) [back to overview]	Time to First New Pulmonary Exacerbation (PEx)
NCT03451045 (6) [back to overview]	FEV1 % Predicted
NCT03451045 (6) [back to overview]	Pulmonary Exacerbation (PEx)
NCT03451045 (6) [back to overview]	CFQ-R Respiratory Symptom Domain
NCT03451045 (6) [back to overview]	Pulmonary Exacerbation (PEx) Rate

Number of Participants With Treatment Emergent Adverse Events.

(NCT02465450)
Timeframe: 84 days of treatment

Intervention	Participants (Count of Participants)
JBT101 1 mg QD	14
JBT-101 5 mg QD	13
Placebo QD	15
JBT-101 20 mg QD	21
JBT-101 20 mg BID	19
Placebo BID	14

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JBT-101 (Lenabasum) Plasma Concentrations on Day 84

Plasma concentrations were reported for the lenabasum 20 mg QD, 20 mg BID, and placebo groups only, at Day 84. (NCT02465450)
Timeframe: Day 84

Intervention	ng/mL (Mean)
Lenabasum 20 mg QD	249.77
Lenabasum 20 mg BID	360.80
Placebo BID	0.00

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Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) From Baseline in Part A.

The CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity, In the CDASI, DM skin disease activity is scored from 0 to 100 based on the physician's evaluation of erythema, scale, and erosion or ulceration at 15 anatomic locations as well as alopecia, Gottron's sign or papules on the hands, and periungual changes. A 5-point or greater decrease in the CDASI activity score indicates clinically relevant improvement based on statistical analysis using a receiver operating characteristic curve to maximize sensitivity and specificity (NCT02466243)
Timeframe: Part A: 84-day treatment period (Change from the Baseline CDSAI score at Day 84)

Intervention	CDASI Activity Score (Least Squares Mean)
Lenabasum	-8.0
Placebo	-5.5

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Change in Patient-reported Outcomes From Baseline at 84 Days for Part A

"LS mean (SE) change from baseline to Week 6 (Day 84) for lenabasum vs. placebo using a mixed model repeated measures analysis~The CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity and damage, In the CDASI, the Damage Score is scored from 0 to 32 based on the physician's evaluation of poikiloderma and calcinosis. 0 representing no damage and 32 representing the greatest level of damage." (NCT02466243)
Timeframe: Part A: 84-day treatment period

Intervention	CDASI Damage Score (Least Squares Mean)
Placebo	-5.5
Lenabasum 20 mg BID	-8.0

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Percentage of Participants Indicating Clinical Benefit in Treatment Satisfaction

"At the end of treatment, the participant and their physician will complete separately a survey asking what treatment assignment they believe they received (e.g., JBT-101, placebo, or cannot tell), whether the participant received benefit from their assigned treatment and whether the participant or their physician would choose the treatment received.~The percentage of participants who responded that they received clinical benefit from the experimental drug treatment at the end of treatment will be assessed." (NCT03093402)
Timeframe: Visit 5 (Day 85 - Last Day of Treatment)

Intervention	Percentage of Participants (Number)
High: JBT-101 20mg/20mg	59.1
Medium: JBT-101 20mg/Placebo	76.0
Low: JBT-101 5mg/5mg	69.6
Placebo	52.2

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Percentage of Participants With Improvement From Baseline in Arthritis in BILAG-2004

The BILAG-2004* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. The severity of arthritis at baseline will be determine by the highest arthritis severity level where arthritis is indicated as improving, same, new or worse* BILAG-2004: British Isles Lupus Assessment Group 2004. The percentage of participants who met the criteria for improvement of arthritis in the BILAG-2004 Musculoskeletal assessments (using the mild, moderate and severe arthritis questions on the assessment) at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)

Intervention	Percentage of Subjects (Number)
High: JBT-101 20mg/20mg	50.0
Medium: JBT-101 20mg/Placebo	56.5
Low: JBT-101 5mg/5mg	78.2
Placebo	58.3

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Percentage of Physicians Indicating Participant Clinical Benefit in Treatment Satisfaction

"At the end of treatment, the participant and their physician will complete separately a survey asking what treatment assignment they believe they received (e.g., JBT-101, placebo, or cannot tell), whether the participant received benefit from their assigned treatment and whether the participant or their physician would choose the treatment received.~The percentage of physicians who responded that the participant received clinical benefit from the experimental drug treatment at the end of treatment will be assessed." (NCT03093402)
Timeframe: Visit 5 (Day 85 - Last Day of Treatment)

Intervention	Percentage of Physicians (Number)
High: JBT-101 20mg/20mg	43.5
Medium: JBT-101 20mg/Placebo	60.0
Low: JBT-101 5mg/5mg	65.2
Placebo	66.7

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Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score

"The change from baseline in the SELENA-SLEDAI score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.~The Safety of Estrogen in Lupus National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a validated tool for assessing SLE disease activity. The SLEDAI is a one page assessment that contains 24 items scored as present or absent. Each item is assigned a weighted score which is summed to calculate the overall SLEDAI score. SLEDAI score ranges from 0-105 points. Higher scores represent more disease activity, with a score of 6 being considered clinically important and may impact the decision to treat." (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

,,,

Intervention	Scores on a Scale (Mean)
	Baseline/Day 1	Day 29	Day 57	Day 85
High: JBT-101 20mg/20mg	6.9	6.1	5.4	4.7
Low: JBT-101 5mg/5mg	7.5	6.0	5.0	4.5
Medium: JBT-101 20mg/Placebo	7.0	5.5	4.5	4.5
Placebo	8.2	6.6	6.1	5.5

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Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score

"For each of the nine domains, a numerical score will be assigned based on the BILAG score as follows: A=12, B=8, C=1 and D/E=0. A single numerical BILAG total score will be calculated for each participant visit as the summation of the numerical scores for each of the nine domains. The BILAG total score can range from 0 to 108, with higher scores indicating more disease activity. The change from baseline in the total BILAG-2004 score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. The BILAG-2004* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems.~* BILAG-2004: British Isles Lupus Assessment Group 2004." (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

,,,

Intervention	Score (Mean)
	Baseline/Day 1	Day 29	Day 57	Day 85
High: JBT-101 20mg/20mg	12.2	8.8	7.9	8.6
Low: JBT-101 5mg/5mg	11.5	6.2	5.4	4.9
Medium: JBT-101 20mg/Placebo	9.7	5.8	6.5	5.1
Placebo	13.1	5.5	8.1	7.7

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Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score

The change from baseline in the total PGA score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. The PGA utilizes a 0 to 3 visual analogue scale for assessing disease activity in SLE that is anchored by the verbal descriptors as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. An increase of >=0.3 points is considered worsening of the PGA. (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

,,,

Intervention	Score (Mean)
	Baseline/Day 1	Day 29	Day 57	Day 85
High: JBT-101 20mg/20mg	1.2	1.2	1.0	0.9
Low: JBT-101 5mg/5mg	1.4	1.0	0.9	0.7
Medium: JBT-101 20mg/Placebo	1.2	0.9	0.8	0.8
Placebo	1.3	1.1	1.0	0.9

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Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score

"The change from baseline in the total Patient Global Assessment score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. The total Patient Global Assessment is performed with a visual analogue scale (0 to 100) in which the participant is asked to indicate how active she/he thinks their disease is. The visual analogue scale is anchored by two descriptors: not active (score of 0) and extremely active (score of 100)." (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)

,,,

Intervention	Score (Mean)
	Baseline/Day 1	Day 29	Day 57	Day 85
High: JBT-101 20mg/20mg	60.2	48.1	48.3	37.0
Low: JBT-101 5mg/5mg	65.6	47.5	50.2	48.7
Medium: JBT-101 20mg/Placebo	67.0	49.2	50.5	48.0
Placebo	65.5	54.4	59.4	58.7

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Change From Baseline in Physician Assessed Swollen Joint Count

The change from baseline in the number of swollen joints identified by the physician in the Physician Joint Exam at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. The number of swollen joints can range from 0 to 66 joints. (NCT03093402)
Timeframe: Baseline, (Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

,,,

Intervention	Number of Swollen Joints (Mean)
	Baseline/ Day 1	Day 29	Day 57	Day 85
High: JBT-101 20mg/20mg	5.4	5.6	3.4	3.3
Low: JBT-101 5mg/5mg	6.8	4.5	2.3	2.1
Medium: JBT-101 20mg/Placebo	7.6	4.0	3.0	3.1
Placebo	9.0	5.3	5.1	4.0

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Change From Baseline in Physician Assessed Tender Joint Count

The change from baseline in the number of tender joints identified by the physician in the Physician Joint Exam at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. The number of tender joints can range from 0 to 68 joints. (NCT03093402)
Timeframe: Baseline, (Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment

,,,

Intervention	Number of Tender Joints (Mean)
	Baseline/ Day 1	Day 29	Day 57	Day 85
High: JBT-101 20mg/20mg	14.1	12.1	9.5	10.3
Low: JBT-101 5mg/5mg	13.1	8.8	5.0	4.7
Medium: JBT-101 20mg/Placebo	15.0	12.3	12.3	11.9
Placebo	18.4	10.0	10.7	11.3

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Change in Baseline in PROMIS - Anxiety T-Score

"The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Anxiety T-Score will be used to assess trends over time in this health measure.~The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Anxiety domain. The change from baseline in PROMIS Anxiety Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed." (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

,,,

Intervention	T-Score (Mean)
	Baseline/Day 1	Day 29	Day 57	Day 85
High: JBT-101 20mg/20mg	57.0	54.7	55.7	52.9
Low: JBT-101 5mg/5mg	56.9	54.1	56.0	54.7
Medium: JBT-101 20mg/Placebo	52.4	53.2	52.6	50.0
Placebo	55.1	51.6	53.4	53.5

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Change in Baseline in PROMIS - Depression T-Score

The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Depression T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Depression domain. The change from baseline in PROMIS Depression Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

,,,

Intervention	Score (Mean)
	Baseline/Day 1	Day 29	Day 57	Day 85
High: JBT-101 20mg/20mg	57.7	53.8	52.9	53.0
Low: JBT-101 5mg/5mg	52.7	49.8	51.8	50.0
Medium: JBT-101 20mg/Placebo	49.6	49.1	49.7	50.0
Placebo	52.1	52.0	51.1	50.6

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Change in Baseline in PROMIS - Fatigue T-Score

The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Fatigue T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Fatigue domain. The change from baseline in PROMIS Fatigue Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

,,,

Intervention	T-Score (Mean)
	Baseline/Day 1	Day 29	Day 57	Day 85
High: JBT-101 20mg/20mg	64.0	61.8	61.7	59.7
Low: JBT-101 5mg/5mg	63.1	58.0	55.8	57.9
Medium: JBT-101 20mg/Placebo	62.4	59.6	57.8	56.7
Placebo	63.7	60.1	59.4	59.0

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Change in Baseline in PROMIS - Pain Intensity

The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Pain Intensity will be used to assess trends over time in this health measure. The Pain Intensity on the PROMIS is a single item numerical rating scale where the respondent selects a whole number representing the average pain of the past 7 days ranging from 0 (no pain) to 10 (worst pain imaginable). The change from baseline in PROMIS Pain Intensity Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

,,,

Intervention	Score (Mean)
	Baseline/ Day 1	Day 29	Day 57	Day 85
High: JBT-101 20mg/20mg	6.6	5.5	5.2	4.7
Low: JBT-101 5mg/5mg	7.0	5.2	4.9	4.6
Medium: JBT-101 20mg/Placebo	6.9	5.3	5.1	5.2
Placebo	6.9	5.8	5.8	5.8

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Change in Baseline in PROMIS - Pain Interference T-Score

The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Pain Interference T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Pain Interference domain. The change from baseline in PROMIS Pain Interference Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

,,,

Intervention	Score (Mean)
	Baseline/Day 1	Day 29	Day 57	Day 85
High: JBT-101 20mg/20mg	64.9	61.6	61.1	58.5
Low: JBT-101 5mg/5mg	65.0	60.4	57.7	60.0
Medium: JBT-101 20mg/Placebo	64.7	61.6	58.5	60.4
Placebo	66.1	61.2	62.0	61.1

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Change in Baseline in PROMIS - Sleep Disturbance T-Score

The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Sleep Disturbance T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Sleep Disturbance domain. The change from baseline in PROMIS Sleep Disturbance Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

,,,

Intervention	Score (Mean)
	Baseline/Day 1	Day 29	Day 57	Day 85
High: JBT-101 20mg/20mg	58.6	56.6	56.0	55.4
Low: JBT-101 5mg/5mg	57.9	57.7	56.4	56.3
Medium: JBT-101 20mg/Placebo	56.4	54.5	53.7	56.4
Placebo	62.6	57.2	57.7	57.2

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Change in Baseline in PROMIS - Social Role Satisfaction T-Score

The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Social Role Satisfaction T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score better functioning for the Social Role Satisfaction domain. The change from baseline in PROMIS Social Role Satisfaction Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

,,,

Intervention	Score (Mean)
	Baseline/Day 1	Day 29	Day 57	Day 85
High: JBT-101 20mg/20mg	42.2	44.9	44.2	46.1
Low: JBT-101 5mg/5mg	44.3	45.1	47.0	47.8
Medium: JBT-101 20mg/Placebo	42.5	44.9	47.1	48.2
Placebo	42.4	47.3	45.9	46.8

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Change in Baseline in PROMIS Cognitive Function T-Score

"The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Cognitive Function scale will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents better cognitive function.~The change from baseline in PROMIS Cognitive Function Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed." (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

,,,

Intervention	T-Score (Mean)
	Baseline/Day 1	Day 29	Day 57	Day 85
High: JBT-101 20mg/20mg	45.5	43.6	44.7	45.0
Low: JBT-101 5mg/5mg	42.3	45.4	45.6	45.8
Medium: JBT-101 20mg/Placebo	45.1	48.3	47.1	48.1
Placebo	42.4	45.4	43.4	44.2

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Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score

"The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Short Form (Version 2.0) will be used to assess trends over time in this state of health measure. The PROMIS-29 consists of 7 domains related to physical, mental and social health. Raw scores are calculated for each domain and translated into a T-score per the PROMIS-29 scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents better functioning for the Physical Function domain.~The change from baseline in the PROMIS-29 Physical Function T-score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85)." (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment)

,,,

Intervention	T-Score (Mean)
	Baseline/Day 1	Day 29	Day 57	Day 85
High: JBT-101 20mg/20mg	37.7	38.5	39.9	39.8
Low: JBT-101 5mg/5mg	39.2	42.1	42.2	41.5
Medium: JBT-101 20mg/Placebo	39.2	39.8	40.0	41.1
Placebo	38.5	40.5	40.4	40.3

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Improvement in the Maximum Daily NRS-Pain Score at Day 84

"The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.~Participants will be asked to report their maximum daily pain using the NRS-Pain. Participants will call into an interactive voice response e diary system (IVRS) and record the number that best reflects their maximum amount of pain experienced in the last 24 hours. Participants will be asked to call at the same time each day, preferably before bedtime.~Longitudinal trends over the course of the treatment period will be modeled and used to estimate difference between means at baseline and Day 84 for each treatment group." (NCT03093402)
Timeframe: Day 1 through Day 84

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Intervention	NRS Pain Score (Least Squares Mean)
	Day 1	Day 84
High: JBT-101 20mg/20mg	6.3	5.1
Low: JBT-101 5mg/5mg	6.0	5.1
Medium: JBT-101 20mg/Placebo	6.4	4.9
Placebo	6.2	5.9

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Number of BILAG-2004 Disease Flares

"The number of BILAG-2004 disease flares as defined as one new BILAG A or two new BILAG B scores will be assessed.~The BILAG-2004* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems.~* BILAG-2004: British Isles Lupus Assessment Group 2004." (NCT03093402)
Timeframe: Visit 3 (Day 29)

,,,

Intervention	Number of Participants (Number)
	One new BILAG A Flare	Two new BILAG B Flares
High: JBT-101 20mg/20mg	0	0
Low: JBT-101 5mg/5mg	0	0
Medium: JBT-101 20mg/Placebo	0	1
Placebo	0	0

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Number of BILAG-2004 Disease Flares

,,,

Intervention	Number of Participants (Number)
	One new BILAG A Flare	Two new BILAG B Flares
High: JBT-101 20mg/20mg	0	0
Low: JBT-101 5mg/5mg	0	1
Medium: JBT-101 20mg/Placebo	0	0
Placebo	1	0

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Number of BILAG-2004 Disease Flares

,,,

Intervention	Number of Participants (Number)
	One new BILAG A Flare	Two new BILAG B Flares
High: JBT-101 20mg/20mg	2	0
Low: JBT-101 5mg/5mg	0	0
Medium: JBT-101 20mg/Placebo	0	0
Placebo	1	0

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Number of BILAG-2004 Disease Flares

,,,

Intervention	Number of Participants (Number)
	One new BILAG A Flare	Two new BILAG B Flares
High: JBT-101 20mg/20mg	0	1
Low: JBT-101 5mg/5mg	1	0
Medium: JBT-101 20mg/Placebo	0	0
Placebo	0	0

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Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)

"The number of mild/moderate and severe disease flares will be assessed using the SFI instrument to define disease flare(s) and severity.~The SELENA SLEDAI Flare Index categorizes disease flares as mild/moderate or severe, based on the highest categories of clinical features recorded or by treatment recommendations by the physician." (NCT03093402)
Timeframe: Visit 3 (Day 29)

,,,

Intervention	Number of Participants (Number)
	Severe	Mild/Moderate	No Flare
High: JBT-101 20mg/20mg	1	4	16
Low: JBT-101 5mg/5mg	1	0	23
Medium: JBT-101 20mg/Placebo	1	2	22
Placebo	0	3	22

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Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)

,,,

Intervention	participants (Number)
	Severe	Mild/Moderate	No Flare
High: JBT-101 20mg/20mg	1	2	17
Low: JBT-101 5mg/5mg	0	3	21
Medium: JBT-101 20mg/Placebo	0	3	20
Placebo	0	7	17

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Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)

,,,

Intervention	participants (Number)
	Severe	Mild/Moderate	No Flare
High: JBT-101 20mg/20mg	0	3	17
Low: JBT-101 5mg/5mg	2	2	19
Medium: JBT-101 20mg/Placebo	1	4	18
Placebo	1	4	19

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Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)

The number of mild/moderate and severe disease flares will be assessed using the SFI instrument to define disease flare(s) and severity. The SELENA SLEDAI Flare Index categorizes disease flares as mild/moderate or severe, based on the highest categories of clinical features recorded or by treatment recommendations by the physician. (NCT03093402)
Timeframe: Visit 6 (Day 113)

,,,

Intervention	participants (Number)
	Severe	Mild/Moderate	No Flare
High: JBT-101 20mg/20mg	0	7	13
Low: JBT-101 5mg/5mg	0	9	14
Medium: JBT-101 20mg/Placebo	0	5	18
Placebo	2	9	13

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Percentage of Participants as Responders Using the SLE Responder Index (SRI)

The SRI is a validated SLE disease activity instrument used to detect clinically meaningful improvement of disease in SLE clinical trials. The SRI is a composite instrument comprised of the SELENA-SLE Disease Activity Index [SELENA-SLEDAI], Physician Global Assessment (PGA) and British Isles Lupus Assessment Group (BILAG) 2004. A responder is defined as having at least a 4 point reduction in the SELENA-SLEDAI score, no new BILAG A or no more than 1 new BILAG B domain score, and no increase in the PGA of 0.3 points or more. The percentage of participants who met the criteria for a responder in the SRI at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)

,,,

Intervention	Percentage of Subjects (Number)
	Day 29	Day 57	Day 85	Day 113
High: JBT-101 20mg/20mg	19.0	40.0	50.0	21.1
Low: JBT-101 5mg/5mg	25.0	41.7	54.5	33.3
Medium: JBT-101 20mg/Placebo	28.0	34.8	39.1	34.8
Placebo	20.0	33.3	39.1	29.2

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Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits

"The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.~The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed." (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)

,,,

Intervention	Percentage of Participants (Number)
	Day 29	Day 57	Day 85	Day 113
High: JBT-101 20mg/20mg	0	0	0	0
Low: JBT-101 5mg/5mg	0	0	4.5	0
Medium: JBT-101 20mg/Placebo	0	4.3	4.8	0
Placebo	0	0	0	0

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Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits

"The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.~The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed." (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)

,,,

Intervention	Percentage of Participants (Number)
	Day 29	Day 57	Day 85	Day 113
High: JBT-101 20mg/20mg	19.0	38.9	42.1	36.4
Low: JBT-101 5mg/5mg	30.4	40.9	40.9	46.7
Medium: JBT-101 20mg/Placebo	33.3	47.8	42.9	31.3
Placebo	20.0	26.1	27.3	27.3

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Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits

"The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.~The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed." (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)

,,,

Intervention	Percentage of Participants (Number)
	Day 29	Day 57	Day 85	Day 113
High: JBT-101 20mg/20mg	14.3	16.7	26.3	9.1
Low: JBT-101 5mg/5mg	17.4	18.2	22.7	20.0
Medium: JBT-101 20mg/Placebo	16.7	13.0	23.8	12.5
Placebo	8.0	13.0	4.5	0

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Number of Grade 3 or Higher Treatment-emergent Adverse Events (TEAE) Related to Study Product

"Treatment-emergent Adverse Events grading will be defined by the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. The number of TEAE will be identified by monitoring participant-reported AEs, vital signs, medical history, physical exams, blood and urine safety tests, 12-lead electrocardiograms, and the Addiction Research Center Inventory-Marijuana (ARCI-M). TEAE are defined as AEs that, in the opinion of the blinded/masked site investigator, are possibly, probably or definitely related to the assigned study treatment." (NCT03093402)
Timeframe: Day 1 after initiation of study intervention through Day 113

Intervention	Number of Events (Number)
High: JBT-101 20mg/20mg	1
Medium: JBT-101 20mg/Placebo	0
Low: JBT-101 5mg/5mg	0
Placebo	0

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Percentage of Participants With Increased Scores From Baseline on ARCI-M

"The percentage of participants who experienced ≥1 score increase on the ARCI-M from the Visit 1 (Day 1) pre-dose assessment at Visit 1 (Day 1) post-dose, Visit 3 (Day 29) and Visit 5 (Day 85) will be assessed.~The ARCI-M questionnaire was completed by subjects at Visit1 (Day 1) pre- and post-dosing, Visit 3 (Day 29) and Visit 5 (Day 85). This is a 12-item true/false questionnaire developed by the National Institutes of Drug Abuse, designed to detect the full range of subjective responses experienced by marijuana users. An answer of true has an assigned value of 1 and an answer of false has an assigned value of 0. The ARCI-M score was computed as the sum of the assigned values for all 12 questions and can range from 0 to 12. If a question is missed, the score is not calculated." (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1-prior to treatment initiation), Visit 1 (Baseline, Day 1-post-treatment initiation) Visit 3 (Day 29) and Visit 5 (Day 85 - Last Day of Treatment)

,,,

Intervention	Percentage of Participants (Number)
	Day 1 Post-Dose	Day 29	Day 85
High: JBT-101 20mg/20mg	25.0	45.0	11.1
Low: JBT-101 5mg/5mg	20.8	29.2	27.3
Medium: JBT-101 20mg/Placebo	11.1	37.5	39.1
Placebo	4.0	36.0	56.5

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Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI

"The Safety of Estrogen in Lupus National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a validated tool for assessing SLE disease activity.~The percentage of participants with arthritis indicated as Present on the SELENA SLEDAI at Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. [A single question on the SELENA SLEDAI with a response of Present or Absent was assessed.]" (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)

,,,

Intervention	Percentage of Participants (Number)
	Day 29	Day 57	Day 85	Day 113
High: JBT-101 20mg/20mg	14.3	30.0	45.0	15.0
Low: JBT-101 5mg/5mg	20.8	45.8	47.8	34.8
Medium: JBT-101 20mg/Placebo	28.0	39.1	39.1	39.1
Placebo	16.0	25.0	33.3	25.0

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Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score

"The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.~The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed." (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)

,,,

Intervention	Percentage of Participants (Number)
	Day 29	Day 57	Day 85	Day 113
High: JBT-101 20mg/20mg	0	11.1	5.3	0
Low: JBT-101 5mg/5mg	8.7	4.5	9.1	0
Medium: JBT-101 20mg/Placebo	4.2	8.7	4.8	12.5
Placebo	4.0	4.3	0	0

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Number of Treatment Emergent Events With Elevated Liver Tests

The number of participants with elevated liver tests, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 x upper limit of normal and total bilirubin > 1.5 x the upper limit of normal, present on repeat testing, at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. (NCT03093402)
Timeframe: Day 1 through Visit 6 (Day 113)

Intervention	Number of Events (Number)
High: JBT-101 20mg/20mg	0
Medium: JBT-101 20mg/Placebo	0
Low: JBT-101 5mg/5mg	0
Placebo	0

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Number of Treatment Emergent Intolerability Events

The number of intolerability events of the study drug, defined as incidence of discontinuation of study product due to TEAEs at least possibly related to study product from Visits 1 (Day 1) through 5 (Day 85) will be assessed. (NCT03093402)
Timeframe: Day 1 after initiation of study intervention through Visit 5 (Day 85 - Last Day of Treatment)

Intervention	Number of Events (Number)
High: JBT-101 20mg/20mg	6
Medium: JBT-101 20mg/Placebo	4
Low: JBT-101 5mg/5mg	0
Placebo	0

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Number of Treatment Emergent QTc Prolongation Events

The number of treatment emergent QTc prolongation events will be identified when QTc prolongation > 500 msec total duration and when the change from Visit 1 (Day 1) QTc interval prior to study drug administration > 60 msec Twelve-lead ECGs were recorded in triplicate at Screening and Visits 1 (Day 1) and 5 (Day 85). The ECGs were evaluated for medically significant abnormalities and QT/QTc intervals. The QT/QTc intervals were measured at Visit 1 (Day 1) before administration and between 2.5 and 3.5 hours after administration of study product in the clinic, at the time of maximum JBT-101 concentration in the blood. (NCT03093402)
Timeframe: Visit 1 (Baseline, Day 1) and Visit 5 (Day 85 - Last Day of Treatment)

Intervention	Number of Events (Number)
High: JBT-101 20mg/20mg	0
Medium: JBT-101 20mg/Placebo	0
Low: JBT-101 5mg/5mg	0
Placebo	0

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Pulmonary Exacerbation (PEx) Rate Over 28 Weeks

Rate of PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo, during the treatment period. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx. (NCT03451045)
Timeframe: 28 weeks (Baseline Day 0 to Week 28)

Intervention	events per participant/28 weeks (Number)
Lenabasum 20 mg BID	0.911
Lenabasum 5 mg BID	0.749
Placebo BID	0.842

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Time to First New Pulmonary Exacerbation (PEx)

Time to first new PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx. The rate is calculate over a 28 week period from visit 1 to week 28 visit (NCT03451045)
Timeframe: 28 weeks (Baseline Day 0 to Week 28)

Intervention	days (Median)
Lenabasum 20 mg BID	162
Lenabasum 5 mg BID	148
Placebo	143

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FEV1 % Predicted

Change from baseline to week 28 in Forced Expiratory Volume in 1 second (FEV1) expressed as a percentage of a normal range. A lower percentage FEV1 is indicative of decrease in lung functionality. The changes observed from baseline to week 28 for lenabasum will be compared with those observed for placebo treated participants. (NCT03451045)
Timeframe: 28 weeks (Change from Baseline Day 0 to Week 28)

Intervention	percentage of Predicted FEV1 (Least Squares Mean)
Lenabasum 20 mg BID	0.014
Lenabasum 5 mg BID	-0.005
Placebo	-0.012

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Pulmonary Exacerbation (PEx)

Time to first PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo. The secondary definition of a PEx is based on the physician's diagnosis of pulmonary exacerbation and commencement of new oral, intravenous, or inhaled antibiotics. A new PEx is defined one that starts 28 or more days after the previous confirmed PEx. (NCT03451045)
Timeframe: 28 weeks (Baseline Day 0 to Week 28)

Intervention	days (Median)
Lenabasum 20 mg BID	116
Lenabasum 5 mg BID	113
Placebo	120

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CFQ-R Respiratory Symptom Domain

Cystic Fibrosis Questionnaire - Revised measures change from baseline in CFQ-R respiratory symptom domain with lenabasum compared to placebo. Subjects >/= 14 years of age. 5 distinct 4-point Likert scales (e.g., always/often/ sometime/never) Scores for each HRQoL domain; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health. (NCT03451045)
Timeframe: 28 weeks (Change from Baseline Day 0 to Week 28)

Intervention	scores on a scale (Least Squares Mean)
Lenabasum 20 mg BID	1.16
Lenabasum 5 mg BID	-2.92
Placebo	-0.96

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Pulmonary Exacerbation (PEx) Rate

Event rate of PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo. The secondary definition of a PEx is based on the physician's diagnosis of pulmonary exacerbation and commencement of new oral, intravenous, or inhaled antibiotics. A new PEx is defined one that starts 28 or more days after the previous confirmed PEx. The PEx rate is calculated as the number of PEx/28 weeks (NCT03451045)
Timeframe: 28 weeks (Baseline Day 0 to Week 28)

Intervention	events per participant/28 weeks (Number)
Lenabasum 20 mg BID	1.08
Lenabasum 5 mg BID	0.91
Placebo	1.03

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Substance	Relationship Strength	Studies	Trials	Classes	Roles
glycine [no description available]	3.55	2	0	alpha-amino acid; amino acid zwitterion; proteinogenic amino acid; serine family amino acid	EC 2.1.2.1 (glycine hydroxymethyltransferase) inhibitor; fundamental metabolite; hepatoprotective agent; micronutrient; neurotransmitter; NMDA receptor agonist; nutraceutical
am 251 AM 251: an analog of SR141716A; structure given in first source. AM-251 : A carbohydrazide obtained by formal condensation of the carboxy group of 1-(2,4-dichlorophenyl)-5-(4-iodophenyl)-4-methyl-1H-pyrazole-3-carboxylic acid with the amino group of 1-aminopiperidine. An antagonist at the CB1 cannabinoid receptor.	2.04	1	0	amidopiperidine; carbohydrazide; dichlorobenzene; organoiodine compound; pyrazoles	antidepressant; antineoplastic agent; apoptosis inducer; CB1 receptor antagonist
hydroxychloroquine Hydroxychloroquine: A chemotherapeutic agent that acts against erythrocytic forms of malarial parasites. Hydroxychloroquine appears to concentrate in food vacuoles of affected protozoa. It inhibits plasmodial heme polymerase. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p970). hydroxychloroquine : An aminoquinoline that is chloroquine in which one of the N-ethyl groups is hydroxylated at position 2. An antimalarial with properties similar to chloroquine that acts against erythrocytic forms of malarial parasites, it is mainly used as the sulfate salt for the treatment of lupus erythematosus, rheumatoid arthritis, and light-sensitive skin eruptions.	4.72	1	1	aminoquinoline; organochlorine compound; primary alcohol; secondary amino compound; tertiary amino compound	anticoronaviral agent; antimalarial; antirheumatic drug; dermatologic drug
indomethacin Indomethacin: A non-steroidal anti-inflammatory agent (NSAID) that inhibits CYCLOOXYGENASE, which is necessary for the formation of PROSTAGLANDINS and other AUTACOIDS. It also inhibits the motility of POLYMORPHONUCLEAR LEUKOCYTES.. indometacin : A member of the class of indole-3-acetic acids that is indole-3-acetic acid in which the indole ring is substituted at positions 1, 2 and 5 by p-chlorobenzoyl, methyl, and methoxy groups, respectively. A non-steroidal anti-inflammatory drug, it is used in the treatment of musculoskeletal and joint disorders including osteoarthritis, rheumatoid arthritis, gout, bursitis and tendinitis.	2.04	1	0	aromatic ether; indole-3-acetic acids; monochlorobenzenes; N-acylindole	analgesic; drug metabolite; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; environmental contaminant; gout suppressant; non-steroidal anti-inflammatory drug; xenobiotic metabolite; xenobiotic
palmidrol palmidrol: a cannabinoid receptor-inactive eCB-related molecule used as prophylactic in helping to prevent respiratory viral infection. palmitoyl ethanolamide : An N-(long-chain-acyl)ethanolamine that is the ethanolamide of palmitic (hexadecanoic) acid.	2.04	1	0	endocannabinoid; N-(long-chain-acyl)ethanolamine; N-(saturated fatty acyl)ethanolamine	anti-inflammatory drug; anticonvulsant; antihypertensive agent; neuroprotective agent
hydroxyproline Hydroxyproline: A hydroxylated form of the imino acid proline. A deficiency in ASCORBIC ACID can result in impaired hydroxyproline formation.. hydroxyproline : A proline derivative that is proline substituted by at least one hydroxy group.	2.13	1	0	4-hydroxyproline; L-alpha-amino acid zwitterion	human metabolite; mouse metabolite; plant metabolite
carbostyril Quinolones: A group of derivatives of naphthyridine carboxylic acid, quinoline carboxylic acid, or NALIDIXIC ACID.. quinolin-2(1H)-one : A quinolone that is 1,2-dihydroquinoline substituted by an oxo group at position 2.	2.31	1	0	monohydroxyquinoline; quinolone	bacterial xenobiotic metabolite
cyclohexanol Cyclohexanols: Monohydroxy derivatives of cyclohexanes that contain the general formula R-C6H11O. They have a camphorlike odor and are used in making soaps, insecticides, germicides, dry cleaning, and plasticizers.. cyclohexanols : An alcohol in which one or more hydroxy groups are attached to a cyclohexane skeleton.	2.02	1	0	cyclohexanols; secondary alcohol	solvent
alpha-aminopyridine alpha-aminopyridine: RN given refers to parent cpd; structure in Merck Index, 9th ed, #485. aminopyridine : Compounds containing a pyridine skeleton substituted by one or more amine groups.	2.31	1	0
dronabinol Dronabinol: A psychoactive compound extracted from the resin of Cannabis sativa (marihuana, hashish). The isomer delta-9-tetrahydrocannabinol (THC) is considered the most active form, producing characteristic mood and perceptual changes associated with this compound.. Delta(9)-tetrahydrocannabinol : A diterpenoid that is 6a,7,8,10a-tetrahydro-6H-benzo[c]chromene substituted at position 1 by a hydroxy group, positions 6, 6 and 9 by methyl groups and at position 3 by a pentyl group. The principal psychoactive constituent of the cannabis plant, it is used for treatment of anorexia associated with AIDS as well as nausea and vomiting associated with cancer chemotherapy.	12.72	45	7	benzochromene; diterpenoid; phytocannabinoid; polyketide	cannabinoid receptor agonist; epitope; hallucinogen; metabolite; non-narcotic analgesic
fluorescein-5-isothiocyanate Fluorescein-5-isothiocyanate: Fluorescent probe capable of being conjugated to tissue and proteins. It is used as a label in fluorescent antibody staining procedures as well as protein- and amino acid-binding techniques.. fluorescein 5-isothiocyanate : The 5-isomer of fluorescein isothiocyanate. Acts as a fluorescent probe capable of being conjugated to tissue and proteins; used as a label in fluorescent antibody staining procedures as well as protein- and amino acid-binding techniques.	2.01	1	0	fluorescein isothiocyanate
hexadecanamide hexadecanamide : A fatty amide that is the carboxamide derived from palmitic acid.	2.04	1	0	primary fatty amide	metabolite
sr141716 [no description available]	2.46	2	0	amidopiperidine; carbohydrazide; dichlorobenzene; monochlorobenzenes; pyrazoles	anti-obesity agent; appetite depressant; CB1 receptor antagonist
cp-55,940 [no description available]	3.18	1	0
1,1-dimethylheptyl-11-hydroxytetrahydrocannabinol HU 211: structure given in first source; HU 211 is active & HU 210 is inactive as canibinoids; functional N-methyl-D-aspartate receptor blocker; RN given is for (6aS-trans)-isomer	3.84	3	0
n-palmitoylglycine N-hexadecanoylglycine : An N-acylglycine in which the acyl group is specified as hexadecanoyl (palmitoyl).	3.57	2	0	fatty amide; N-acylglycine 16:0	human metabolite; marine metabolite
arachidonic acid icosa-5,8,11,14-tetraenoic acid : Any icosatetraenoic acid with the double bonds at positions 5, 8, 11 and 14.. arachidonate : A long-chain fatty acid anion resulting from the removal of a proton from the carboxy group of arachidonic acid.	3.61	2	0	icosa-5,8,11,14-tetraenoic acid; long-chain fatty acid; omega-6 fatty acid	Daphnia galeata metabolite; EC 3.1.1.1 (carboxylesterase) inhibitor; human metabolite; mouse metabolite
delta-8-tetrahydrocannabinol [no description available]	3.18	1	0	1-benzopyran
cannabidiol Cannabidiol: Compound isolated from Cannabis sativa extract.. cannabidiol : An cannabinoid that is cyclohexene which is substituted by a methyl group at position 1, a 2,6-dihydroxy-4-pentylphenyl group at position 3, and a prop-1-en-2-yl group at position 4.	3.84	3	0	olefinic compound; phytocannabinoid; resorcinols	antimicrobial agent; plant metabolite
gw9662 2-chloro-5-nitrobenzanilide: pretreatment of peroxisome proliferator activated receptors with GW9662 results in the irreversible loss of ligand binding	2.04	1	0	benzamides
jhw 015 [no description available]	3.18	1	0	indolecarboxamide
am 630 iodopravadoline: an aminoalkylindole; a competitive cannabinoid receptor antagonist; structure given in first source	2.04	1	0	N-acylindole
3-(2-hydroxy-4-(1,1-dimethylheptyl)phenyl)-4-(3-hydroxypropyl)cyclohexanol 3-(2-hydroxy-4-(1,1-dimethylheptyl)phenyl)-4-(3-hydroxypropyl)cyclohexanol: (-)-CP-55,940 and (+)-CP-56,667 are enantiomers; RN refers to CP-55,940	2.02	1	0	alkylbenzene; ring assembly
lipoxin a4 lipoxin A4: an antifibrolytic agent; structure given in first source; a role in ASPIRIN antiinflammatory activity. lipoxin A4 : A C20 hydroxy fatty acid having (5S)-, (6R)- and (15S)-hydroxy groups as well as (7E)- (9E)-, (11Z)- and (13E)-double bonds.	2.05	1	0	hydroxy polyunsaturated fatty acid; lipoxin; long-chain fatty acid	human metabolite; metabolite
anandamide anandamide : An N-acylethanolamine 20:4 resulting from the formal condensation of carboxy group of arachidonic acid with the amino group of ethanolamine.	3.56	2	0	endocannabinoid; N-acylethanolamine 20:4	human blood serum metabolite; neurotransmitter; vasodilator agent
arachidonyl dopamine arachidonyl dopamine: a ligand for the vanilloid receptor VR1	3.56	2	0	catechols; fatty amide; N-(fatty acyl)-dopamine; secondary carboxamide
n-oleoyldopamine N-oleoyldopamine: putative capsaicin receptor ligand; produces hyperalgesia; isolated from the brain. N-oleoyldopamine : A fatty amide resulting from the formal condensation of the carboxy group of oleic acid with the amino group of dopamine. Synthesised in catecholaminergic neurons, it crosses the blood-brain barrier and might be considered as a carrier of dopamine into the brain. It is a transient receptor potential vanilloid type 1 (TRPV1) receptor agonist.	2.04	1	0	catechols; fatty amide; N-(fatty acyl)-dopamine; secondary carboxamide	TRPV1 agonist
homo-gamma-linolenylethanolamide homo-gamma-linolenylethanolamide: found in brain; binds to the cannabinoid receptor; RN given for (Z,Z,Z)-isomer; structure given in first source	2.04	1	0	N-acylethanolamine 20:3
7,10,13,16-docosatetraenylethanolamide 7,10,13,16-docosatetraenylethanolamide: found in brain; binds to the cannabinoid receptor; structure given in first source; RN given refers to (ALL-Z)-isomer	2.04	1	0	N-acylethanolamine 22:4
glyceryl 2-arachidonate glyceryl 2-arachidonate: binds to cannabinoid receptors; structure in first source. 2-arachidonoylglycerol : An endocannabinoid and an endogenous agonist of the cannabinoid receptors (CB1 and CB2). It is an ester formed from omega-6-arachidonic acid and glycerol.	3.18	1	0	2-acylglycerol 20:4; endocannabinoid	human metabolite
oleylamide oleylamide: plastic additive; can cause contact urticaria; RN given refers to (Z)-isomer; a sleep inducing factor. aliphatic amide : A carboxamide in which the amide linkage is bonded directly to an aliphatic system.. oleamide : A fatty amide derived from oleic acid.	2.04	1	0	primary fatty amide	human metabolite; plant metabolite
n-arachidonylglycine N-arachidonylglycine: structure in first source. N-arachidonoylglycine : Biologically active derivative of anandamide	4.36	3	0	fatty amide; N-acylglycine
arachidonoyl amine arachidonoyl amine : A primary fatty amide resulting from the formal condensation of the carboxy group of arachidonic acid with ammonia.	2.04	1	0	primary fatty amide	cannabinoid receptor agonist
linoleoyl ethanolamide linoleoyl ethanolamide: RN given for (Z,Z)-isomer. linoleoyl ethanolamide : An N-acylethanolamine 18:2 that is the ethanolamide of linoleic acid.	2.04	1	0	N-acylethanolamine 18:2	EC 3.5.1.99 (fatty acid amide hydrolase) inhibitor
n-oleoylethanolamine N-oleoylethanolamine: ceramidase inhibitor. oleoyl ethanolamide : An N-(long-chain-acyl)ethanolamine that is the ethanolamide of oleic acid. The monounsaturated analogue of the endocannabinoid anandamide.	2.04	1	0	endocannabinoid; N-(long-chain-acyl)ethanolamine; N-acylethanolamine 18:1	EC 3.5.1.23 (ceramidase) inhibitor; geroprotector; PPARalpha agonist
nabilone nabilone: cannabinol deriv; RN given refers to cpd without isomeric designation; structure	3.18	1	0
arachidonyl-2-chloroethylamide arachidonyl-2-chloroethylamide: a potent and selective agonist of the neuronal cannabinoid receptor; structure in first source. arachidonyl-2'-chloroethylamide : A fatty amide obtained by the formal condensation of arachidonic acid with 2-chloroethanamine. It is a potent agonist of the CB1 receptor (Ki = 1.4 nM) and also has a low affinity for the CB2 receptor (Ki = 3100 nM).	3.18	1	0	fatty amide; organochlorine compound; secondary carboxamide; synthetic cannabinoid	CB1 receptor agonist; CB2 receptor agonist; neuroprotective agent
arachidonylcyclopropylamide arachidonylcyclopropylamide: a potent and selective agonist of neuronal cannabinoid receptor; structure in first source	3.18	1	0
l 759633 L 759633: structure in first source	3.18	1	0	1-benzopyran
(3r)-((2,3-dihydro-5-methyl-3-((4-morpholinyl)methyl)pyrrolo-(1,2,3-de)-1,4-benzoxazin-6-yl)(1-naphthalenyl))methanone WIN 55212-2 : A organic heterotricyclic compound that is 5-methyl-3-(morpholin-4-ylmethyl)-2,3-dihydro[1,4]oxazino[2,3,4-hi]indole substituted at position 6 by a 1-naphthylcarbonyl group.	3.18	1	0	morpholines; naphthyl ketone; organic heterotricyclic compound; synthetic cannabinoid	analgesic; apoptosis inhibitor; neuroprotective agent
virodhamine virodhamine: arachidonic acid and ethanolamine joined by an ester linkage, like anandamide with oxygen and nitrogen reversed; an endocannabinoid from rat; structure in first source	3.18	1	0	fatty acid ester
am-356 methanandamide: structure given in first source; RN given refers to (all-Z)-(+-)-isomer	3.18	1	0	fatty amide
noladin ether noladin ether: a cannabinoid CB1 receptor agonist; structure in first source. 2-arachidonyl glyceryl ether : A monoalkylglycerol that is glycerol which is substituted by a (5Z,8Z,11Z,14Z)-icosa-5,8,11,14-tetraen-1-yl group at position 2.	3.18	1	0	2-alkylglycerol; endocannabinoid; monoalkylglycerol
jwh-133 1,1-dimethylbutyl-1-deoxy-Delta(9)-THC: a CB2 receptor agonists; no further information available on 8/2001. JWH-133 : A dibenzopyran that is Delta(9)-tetrahydrocannabinol which is lacking the hydroxy group and in which the pentyl group at position 3 has been replaced by a 1,1-dimethylbutyl group. A potent and highly selective CB2 receptor agonist.	3.18	1	0	benzochromene; dibenzopyran; organic heterotricyclic compound	analgesic; anti-inflammatory agent; antineoplastic agent; apoptosis inhibitor; CB2 receptor agonist; opioid analgesic; vasodilator agent
CB-13 naphthalen-1-yl-(4-pentyloxynaphthalen-1-yl)methanone: has antihyperalgesic activity; structure in first source	2.07	1	0	benzophenones
hu 210 [no description available]	3.18	1	0	1-benzopyran
1-(2,3-dichlorobenzoyl)-5-methoxy-2-methyl-(2-(mopholin-4-yl)ethyl)-1h-indole [no description available]	3.18	1	0	N-acylindole
am 1241 AM 1241: a CB(2) receptor-selective agonist; no further information available 11/2001	3.18	1	0
1-(2,4-dichlorophenyl)-6-methyl-N-(1-piperidinyl)-4H-indeno[1,2-c]pyrazole-3-carboxamide [no description available]	3.18	1	0	pyrazoles; ring assembly
jwh 018 1-pentyl-3-(1-naphthoyl)indole: structure in first source	3.18	1	0	indolecarboxamide
hu 308 HU 308: a specific agonist for CB(2), a peripheral cannabinoid receptor; structure in first source. HU-308 : A carbobicyclic compound that is bicyclo[3.1.1]hept-2-ene which is substituted by a hydroxymethyl group at position 2, a 2,6-dimethoxy-4-(2-methyloctan-2-yl)phenyl group at position 4, and two methyl groups at position 6 (the 1S,4S,5S stereoisomer). A highly selective and effective cannabinoid type-2 agonist and the enantiomer of HU-433.	3.18	1	0	aromatic ether; bridged compound; carbobicyclic compound; primary allylic alcohol; synthetic cannabinoid	anti-inflammatory agent; antihypertensive agent; apoptosis inhibitor; bone density conservation agent; CB2 receptor agonist
a-836339 A-836339: structure in first source	3.18	1	0
n-arachidonoylalanine N-arachidonoylalanine: inhibits fatty acid amide hydrolase; structure in first source. N-arachidonoyl-L-alanine : An N-acyl-L-alanine resulting from the formal condensation of the amino group of L-alanine with the carboxy group of arachidonic acid.	3.57	2	0	N-(fatty acyl)-L-alpha-amino acid; N-acyl-L-alanine	mammalian metabolite
piperidines Piperidines: A family of hexahydropyridines.	2.44	2	0
interleukin-8 Interleukin-8: A member of the CXC chemokine family that plays a role in the regulation of the acute inflammatory response. It is secreted by variety of cell types and induces CHEMOTAXIS of NEUTROPHILS and other inflammatory cells.	2.01	1	0
s-777469 S-777469: an orally available cannabinoid receptor CB2 agonist as an antipruritic agent; structure in first source	3.18	1	0
lumacaftor, ivacaftor drug combination Orkambi : A two-drug mixture consisting of lumacaftor and ivacaftor, which is used for the treatment of cystic fibrosis.	2.31	1	0
guanosine 5'-o-(3-thiotriphosphate) Guanosine 5'-O-(3-Thiotriphosphate): Guanosine 5'-(trihydrogen diphosphate), monoanhydride with phosphorothioic acid. A stable GTP analog which enjoys a variety of physiological actions such as stimulation of guanine nucleotide-binding proteins, phosphoinositide hydrolysis, cyclic AMP accumulation, and activation of specific proto-oncogenes.	2.02	1	0	nucleoside triphosphate analogue

Condition	Indicated	Relationship Strength	Studies	Trials
Ache [description not available]	0	3.86	4	0
Pain An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.	0	3.86	4	0
Acute Relapsing Multiple Sclerosis [description not available]	0	2.41	1	0
Allergic Encephalomyelitis [description not available]	0	2.41	1	0
Multiple Sclerosis, Relapsing-Remitting The most common clinical variant of MULTIPLE SCLEROSIS, characterized by recurrent acute exacerbations of neurologic dysfunction followed by partial or complete recovery. Common clinical manifestations include loss of visual (see OPTIC NEURITIS), motor, sensory, or bladder function. Acute episodes of demyelination may occur at any site in the central nervous system, and commonly involve the optic nerves, spinal cord, brain stem, and cerebellum. (Adams et al., Principles of Neurology, 6th ed, pp903-914)	0	2.41	1	0
Dermatomyositis, Adult Type [description not available]	0	6.09	4	2
Dermatomyositis A subacute or chronic inflammatory disease of muscle and skin, marked by proximal muscle weakness and a characteristic skin rash. The illness occurs with approximately equal frequency in children and adults. The skin lesions usually take the form of a purplish rash (or less often an exfoliative dermatitis) involving the nose, cheeks, forehead, upper trunk, and arms. The disease is associated with a complement mediated intramuscular microangiopathy, leading to loss of capillaries, muscle ischemia, muscle-fiber necrosis, and perifascicular atrophy. The childhood form of this disease tends to evolve into a systemic vasculitis. Dermatomyositis may occur in association with malignant neoplasms. (From Adams et al., Principles of Neurology, 6th ed, pp1405-6)	1	8.09	4	2
Innate Inflammatory Response [description not available]	0	4.55	5	0
Inflammation A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function.	0	9.55	5	0
Diffuse Cutaneous Systemic Sclerosis [description not available]	0	8.99	1	1
Sclerosis, Systemic [description not available]	0	4.82	3	2
Scleroderma, Systemic A chronic multi-system disorder of CONNECTIVE TISSUE. It is characterized by SCLEROSIS in the SKIN, the LUNGS, the HEART, the GASTROINTESTINAL TRACT, the KIDNEYS, and the MUSCULOSKELETAL SYSTEM. Other important features include diseased small BLOOD VESSELS and AUTOANTIBODIES. The disorder is named for its most prominent feature (hard skin), and classified into subsets by the extent of skin thickening: LIMITED SCLERODERMA and DIFFUSE SCLERODERMA.	0	4.82	3	2
Scleroderma, Diffuse A rapid onset form of SYSTEMIC SCLERODERMA with progressive widespread SKIN thickening over the arms, the legs and the trunk, resulting in stiffness and disability.	1	5.99	1	1
Cystic Fibrosis of Pancreas [description not available]	0	5.29	3	1
Cystic Fibrosis An autosomal recessive genetic disease of the EXOCRINE GLANDS. It is caused by mutations in the gene encoding the CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR expressed in several organs including the LUNG, the PANCREAS, the BILIARY SYSTEM, and the SWEAT GLANDS. Cystic fibrosis is characterized by epithelial secretory dysfunction associated with ductal obstruction resulting in AIRWAY OBSTRUCTION; chronic RESPIRATORY INFECTIONS; PANCREATIC INSUFFICIENCY; maldigestion; salt depletion; and HEAT PROSTRATION.	1	7.29	3	1
Sensitivity and Specificity Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)	0	3.85	2	1
Chronic Illness [description not available]	0	3.09	1	0
Chronic Disease Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care (Dictionary of Health Services Management, 2d ed). For epidemiological studies chronic disease often includes HEART DISEASES; STROKE; CANCER; and diabetes (DIABETES MELLITUS, TYPE 2).	0	3.09	1	0
Disease Exacerbation [description not available]	0	2.13	1	0
Disease Models, Animal Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases.	0	4.34	7	0
Alveolitis, Fibrosing [description not available]	0	2.13	1	0
Pulmonary Fibrosis A process in which normal lung tissues are progressively replaced by FIBROBLASTS and COLLAGEN causing an irreversible loss of the ability to transfer oxygen into the bloodstream via PULMONARY ALVEOLI. Patients show progressive DYSPNEA finally resulting in death.	0	2.13	1	0
Behavior Disorders [description not available]	0	3.06	1	0
Nervous System Disorders [description not available]	0	3.06	1	0
Mental Disorders Psychiatric illness or diseases manifested by breakdowns in the adaptational process expressed primarily as abnormalities of thought, feeling, and behavior producing either distress or impairment of function.	0	3.06	1	0
Nervous System Diseases Diseases of the central and peripheral nervous system. This includes disorders of the brain, spinal cord, cranial nerves, peripheral nerves, nerve roots, autonomic nervous system, neuromuscular junction, and muscle.	0	3.06	1	0
Rheumatoid Arthritis [description not available]	0	2.04	1	0
Psoriasis Arthropathica [description not available]	0	2.04	1	0
Arthritis, Rheumatoid A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated.	0	2.04	1	0
Arthritis, Psoriatic A type of inflammatory arthritis associated with PSORIASIS, often involving the axial joints and the peripheral terminal interphalangeal joints. It is characterized by the presence of HLA-B27-associated SPONDYLARTHROPATHY, and the absence of rheumatoid factor.	0	2.04	1	0
Primary Peritonitis [description not available]	0	2.05	1	0
Peritonitis INFLAMMATION of the PERITONEUM lining the ABDOMINAL CAVITY as the result of infectious, autoimmune, or chemical processes. Primary peritonitis is due to infection of the PERITONEAL CAVITY via hematogenous or lymphatic spread and without intra-abdominal source. Secondary peritonitis arises from the ABDOMINAL CAVITY itself through RUPTURE or ABSCESS of intra-abdominal organs.	0	2.05	1	0
Diffuse Myofascial Pain Syndrome [description not available]	0	2.96	1	0
Fibromyalgia A common nonarticular rheumatic syndrome characterized by myalgia and multiple points of focal muscle tenderness to palpation (trigger points). Muscle pain is typically aggravated by inactivity or exposure to cold. This condition is often associated with general symptoms, such as sleep disturbances, fatigue, stiffness, HEADACHES, and occasionally DEPRESSION. There is significant overlap between fibromyalgia and the chronic fatigue syndrome (FATIGUE SYNDROME, CHRONIC). Fibromyalgia may arise as a primary or secondary disease process. It is most frequent in females aged 20 to 50 years. (From Adams et al., Principles of Neurology, 6th ed, p1494-95)	0	2.96	1	0
Cirrhosis [description not available]	0	2.07	1	0
Fibrosis Any pathological condition where fibrous connective tissue invades any organ, usually as a consequence of inflammation or other injury.	0	2.07	1	0
Adjuvant Arthritis [description not available]	0	3.63	3	0
Nerve Pain [description not available]	0	5.24	4	1
Neuralgia Intense or aching pain that occurs along the course or distribution of a peripheral or cranial nerve.	0	5.24	4	1
Allodynia [description not available]	0	3.41	1	1
Lesion of Sciatic Nerve [description not available]	0	2.02	1	0
Anochlesia [description not available]	0	2.02	1	0
Hypothermia, Accidental [description not available]	0	2.02	1	0
Hypothermia Lower than normal body temperature, especially in warm-blooded animals.	0	2.02	1	0
Diabetes Mellitus, Adult-Onset [description not available]	0	2.94	1	0
Diabetes Mellitus, Type 2 A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.	0	2.94	1	0
Anasarca [description not available]	0	2.94	1	0
Edema Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE.	0	2.94	1	0
Gastritis Inflammation of the GASTRIC MUCOSA, a lesion observed in a number of unrelated disorders.	0	2.94	1	0
Bladder, Overactive [description not available]	0	2.03	1	0
Urinary Bladder, Overactive Symptom of overactive detrusor muscle of the URINARY BLADDER that contracts with abnormally high frequency and urgency. Overactive bladder is characterized by the frequent feeling of needing to urinate during the day, during the night, or both. URINARY INCONTINENCE may or may not be present.	0	2.03	1	0

lenabasum

Description

Cross-References

Synonyms (49)

Research Excerpts

Overview

Treatment

Toxicity

Compound-Compound Interactions

Dosage Studied

Protein Targets (2)

Inhibition Measurements

Activation Measurements

Biological Processes (39)

Molecular Functions (4)

Ceullar Components (13)

Bioassays (30)

Research

Studies (48)

Market Indicators

Research Demand Index: 33.89

Study Types

Clinical Trials (6)

Trial Overview

Trial Outcomes

Number of Participants With Treatment Emergent Adverse Events.

JBT-101 (Lenabasum) Plasma Concentrations on Day 84

Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) From Baseline in Part A.

Change in Patient-reported Outcomes From Baseline at 84 Days for Part A

Percentage of Participants Indicating Clinical Benefit in Treatment Satisfaction

Percentage of Participants With Improvement From Baseline in Arthritis in BILAG-2004

Percentage of Physicians Indicating Participant Clinical Benefit in Treatment Satisfaction

Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score

Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score

Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score

Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score

Change From Baseline in Physician Assessed Swollen Joint Count

Change From Baseline in Physician Assessed Tender Joint Count

Change in Baseline in PROMIS - Anxiety T-Score

Change in Baseline in PROMIS - Depression T-Score

Change in Baseline in PROMIS - Fatigue T-Score

Change in Baseline in PROMIS - Pain Intensity

Change in Baseline in PROMIS - Pain Interference T-Score

Change in Baseline in PROMIS - Sleep Disturbance T-Score

Change in Baseline in PROMIS - Social Role Satisfaction T-Score

Change in Baseline in PROMIS Cognitive Function T-Score

Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score

Improvement in the Maximum Daily NRS-Pain Score at Day 84

Number of BILAG-2004 Disease Flares

Number of BILAG-2004 Disease Flares

Number of BILAG-2004 Disease Flares

Number of BILAG-2004 Disease Flares

Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)

Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)

Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)

Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)

Percentage of Participants as Responders Using the SLE Responder Index (SRI)

Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits

Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits

Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits

Number of Grade 3 or Higher Treatment-emergent Adverse Events (TEAE) Related to Study Product

Percentage of Participants With Increased Scores From Baseline on ARCI-M

Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI

Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score

Number of Treatment Emergent Events With Elevated Liver Tests

Number of Treatment Emergent Intolerability Events

Number of Treatment Emergent QTc Prolongation Events

Pulmonary Exacerbation (PEx) Rate Over 28 Weeks

Time to First New Pulmonary Exacerbation (PEx)

FEV1 % Predicted

Pulmonary Exacerbation (PEx)

CFQ-R Respiratory Symptom Domain

Pulmonary Exacerbation (PEx) Rate

Related Drugs (58)

Related Conditions (51)