| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa [NCT03836001] | Phase 2 | 28 participants (Actual) | Interventional | 2019-04-18 | Completed |
| A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus in Adults With Prurigo Nodularis [NCT03546816] | Phase 3 | 285 participants (Actual) | Interventional | 2018-05-02 | Completed |
| A Randomized, Double-Blind, Placebo Controlled Study Of The Efficacy, Safety, And Tolerability Of Serlopitant For The Treatment Of Pruritus In Adults And Adolescents With A History Of Atopic Dermatitis [NCT02975206] | Phase 2 | 484 participants (Actual) | Interventional | 2016-11-30 | Completed |
| A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin [NCT03841331] | Phase 2 | 233 participants (Actual) | Interventional | 2019-01-22 | Completed |
| A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus in Adults With Plaque Psoriasis [NCT03343639] | Phase 2 | 204 participants (Actual) | Interventional | 2017-11-01 | Completed |
| An Open-Label Long-Term Safety Study of Serlopitant for the Treatment of Pruritus [NCT03540160] | Phase 3 | 558 participants (Actual) | Interventional | 2018-03-15 | Terminated(stopped due to No longer pursuing development of serlopitant) |
| A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus Following Burn Injury [NCT02975271] | Phase 2 | 1 participants (Actual) | Interventional | 2016-11-30 | Terminated(stopped due to Business Reasons) |
| A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus in Adults With Prurigo Nodularis [NCT03677401] | Phase 3 | 295 participants (Actual) | Interventional | 2018-08-29 | Completed |
| A Phase II Randomized, Double Blind, Parallel Group, Placebo-Controlled Dose Finding and Efficacy Study of VPD-737 in the Treatment of Subjects With Chronic Pruritus [NCT01951274] | Phase 2 | 257 participants (Actual) | Interventional | 2013-10-15 | Completed |
| A Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough [NCT03282591] | Phase 2 | 185 participants (Actual) | Interventional | 2017-10-03 | Completed |
| A Phase 2 Trial of Neurokinin-1 Receptor Antagonist for the Treatment of Itch in Epidermolysis Bullosa Patients [NCT02654483] | Phase 2 | 14 participants (Actual) | Interventional | 2016-08-31 | Completed |
| A Randomized, Double-Blind, Placebo-Controlled, Study of Neurokinin-1 Receptor Antagonist Serlopitant in Subjects With Prurigo Nodularis [NCT02196324] | Phase 2 | 128 participants (Actual) | Interventional | 2014-07-09 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
| Trial | Outcome |
|---|
| NCT02196324 (17) [back to overview] | Average Visual Analog Scale at Week 8 |
| NCT02196324 (17) [back to overview] | Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning |
| NCT02196324 (17) [back to overview] | Number of Participants With Adverse Events (AEs) |
| NCT02196324 (17) [back to overview] | Dermatology Life Quality Index (DLQI) |
| NCT02196324 (17) [back to overview] | Patient Benefit Index, Version for Patients With Pruritus (PBI-P) |
| NCT02196324 (17) [back to overview] | Worst Visual Analog Scale (VAS) |
| NCT02196324 (17) [back to overview] | Average Visual Analog Scale at Week 4 |
| NCT02196324 (17) [back to overview] | Average Visual Analog Scale at Week 2 |
| NCT02196324 (17) [back to overview] | Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA) |
| NCT02196324 (17) [back to overview] | Average Visual Analog Scale at Baseline |
| NCT02196324 (17) [back to overview] | Pruritus-specific Quality of Life (ItchyQoL) |
| NCT02196324 (17) [back to overview] | Participants With Rescue Medication Usage |
| NCT02196324 (17) [back to overview] | Numeric Rating Scale (NRS) |
| NCT02196324 (17) [back to overview] | Number of Participants With Improvement on Prurigo Activity Score (PAS) |
| NCT02196324 (17) [back to overview] | Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus |
| NCT02196324 (17) [back to overview] | Number of Participants With Improvement in Pruritus as Reported on Patient Global Assessment (PGA) |
| NCT02196324 (17) [back to overview] | Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging |
| NCT02654483 (3) [back to overview] | Wound Healing Determination |
| NCT02654483 (3) [back to overview] | Change in Mean NRS Itch Score During Bathing/Dressing Changes |
| NCT02654483 (3) [back to overview] | Comparative Weekly Change in NRS Itch Score Over the 8-week Active Treatment Period |
| NCT02975206 (3) [back to overview] | Change in Quality of Life (ItchyQoL) From Baseline to Week 6 |
| NCT02975206 (3) [back to overview] | Change in WI-NRS From Baseline to Week 6 |
| NCT02975206 (3) [back to overview] | WI-NRS 4-point Responder Rate at Week 6 |
| NCT03282591 (5) [back to overview] | Change in Awake Objective Cough Frequency |
| NCT03282591 (5) [back to overview] | Change From Baseline in Cough Severity Visual Analog Scale (VAS) |
| NCT03282591 (5) [back to overview] | Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency |
| NCT03282591 (5) [back to overview] | Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency |
| NCT03282591 (5) [back to overview] | Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo) |
| NCT03343639 (4) [back to overview] | Change in WI-NRS From Baseline to Day 3 |
| NCT03343639 (4) [back to overview] | WI-NRS 4-point Responder Rate at Week 4 |
| NCT03343639 (4) [back to overview] | WI-NRS 4-point Responder Rate at Week 8 |
| NCT03343639 (4) [back to overview] | Change in WI-NRS From Baseline to Day 7 |
| NCT03540160 (1) [back to overview] | Number of Subjects With Treatment-emergent Adverse Events |
| NCT03546816 (10) [back to overview] | Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10 |
| NCT03546816 (10) [back to overview] | Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) |
| NCT03546816 (10) [back to overview] | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 |
| NCT03546816 (10) [back to overview] | Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10 |
| NCT03546816 (10) [back to overview] | Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10 |
| NCT03546816 (10) [back to overview] | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10 |
| NCT03546816 (10) [back to overview] | Percent of Subjects With WI-NRS 4-point Responder at Week 4 |
| NCT03546816 (10) [back to overview] | Percent of Subjects With WI-NRS 4-point Responder at Week 2 |
| NCT03546816 (10) [back to overview] | Change From Baseline in DLQI Question 1 to Week 10 |
| NCT03546816 (10) [back to overview] | Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10 |
| NCT03677401 (10) [back to overview] | Percent of Participants With WI-NRS 4-point Responder Rate at Week 4 |
| NCT03677401 (10) [back to overview] | Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10 |
| NCT03677401 (10) [back to overview] | Percent of Participants With WI-NRS 4-point Responder Rate at Week 2 |
| NCT03677401 (10) [back to overview] | Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10 |
| NCT03677401 (10) [back to overview] | Change From Baseline in DLQI Question 1 to Week 10 |
| NCT03677401 (10) [back to overview] | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10 |
| NCT03677401 (10) [back to overview] | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Stage (IGA PN-S) to Weeks 2, 4, and 10 |
| NCT03677401 (10) [back to overview] | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 |
| NCT03677401 (10) [back to overview] | Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) |
| NCT03677401 (10) [back to overview] | Percent of Participants With WI-NRS 3-point Responder at Weeks 2, 4, and 10 |
| NCT03836001 (10) [back to overview] | Weekly AI-NRS |
| NCT03836001 (10) [back to overview] | Weekly Worst Itch NRS |
| NCT03836001 (10) [back to overview] | Patient Global Impression of Change (PGIC) |
| NCT03836001 (10) [back to overview] | Dressing/Bathing NRS |
| NCT03836001 (10) [back to overview] | Change in Static Participant Assessment of Itch |
| NCT03836001 (10) [back to overview] | Number of Patients Who Achieve at Least a 50% Reduction in AI-NRS. |
| NCT03836001 (10) [back to overview] | Number of Patients Who Achieve at Least a 4-point Reduction in AI-NRS. |
| NCT03836001 (10) [back to overview] | Number of Patients Who Achieve at Least a 30% Reduction in AI-NRS. |
| NCT03836001 (10) [back to overview] | Number of Patients Who Achieve at Least a 3-point Reduction in AI-NRS. |
| NCT03836001 (10) [back to overview] | Number of Patients Who Achieve at Least a 2-point Reduction in AI-NRS. |
| NCT03841331 (8) [back to overview] | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
| NCT03841331 (8) [back to overview] | WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8 |
| NCT03841331 (8) [back to overview] | WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10 |
| NCT03841331 (8) [back to overview] | Plasma Concentrations of Serlopitant and Metabolites |
| NCT03841331 (8) [back to overview] | Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10 |
| NCT03841331 (8) [back to overview] | Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10 |
| NCT03841331 (8) [back to overview] | Change From Baseline in Daily WI-NRS Scores Through Week 2 |
| NCT03841331 (8) [back to overview] | Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10 |
Average Visual Analog Scale at Week 8
"At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of no itch (0 cm) and worst imaginable itch (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome." (NCT02196324)
Timeframe: At Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Placebo | 5.56 |
| Serlopitant | 4.21 |
Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning
At study visits, participants used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present). Higher scores indicated worse outcome. (NCT02196324)
Timeframe: At Baseline and Week 8
| Intervention | Participants (Count of Participants) |
|---|
| Baseline, Not Present | Baseline, Mild Present | Baseline, Moderately Present | Baseline, Severely Present | Baseline, Very Severely Present | Week 8, Not Present | Week 8, Mild Present | Week 8, Moderately Present | Week 8, Severely Present | Week 8, Very Severely Present |
|---|
| Placebo | 14 | 8 | 13 | 18 | 9 | 11 | 9 | 15 | 5 | 3 |
,| Serlopitant | 21 | 5 | 21 | 12 | 5 | 31 | 10 | 8 | 6 | 1 |
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, without any judgment about causality. (NCT02196324)
Timeframe: From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10)
| Intervention | Participants (Count of Participants) |
|---|
| Participants with AEs | Participants with Treatment-emergent adverse events (TEAEs) | Participants with TEAEs leading to discontinuation | Participants with TEAEs related to study drug | Participants with TEAEs by maximum severity, Mild | Participants with TEAEs by maximum severity, Moderate | Participants with TEAEs by maximum severity, Severe | Participants with serious TEAEs |
|---|
| Placebo | 39 | 39 | 6 | 22 | 14 | 22 | 3 | 2 |
,| Serlopitant | 46 | 46 | 3 | 31 | 18 | 22 | 6 | 3 |
Dermatology Life Quality Index (DLQI)
"At each visit, participants completed a DLQI questionnaire. The DLQI is a validated questionnaire consisting of 10 questions relating to the degree to which the participant's skin condition affected his/her daily activities. The DLQI questionnaire is designed for use in adults, i.e. participants over the age of 16.~The scoring of each question is as follows:~Very much: scored 3, A lot: scored 2, A little: scored 1, Not at all: scored 0, Not relevant: scored 0, Question 7, 'prevented work or studying': scored 3.~The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.~Interpreting the DLQI Scores:~0 - 1: no effect at all on participant's life, 2 - 5: small effect on participant's life, 6 - 10: moderate effect on participant's life, 11 - 20: very large effect on participant's life, 21 - 30: extremely large effect on participant's life." (NCT02196324)
Timeframe: At Baseline, Weeks 2, 4, and 8
| Intervention | Units on a scale (Mean) |
|---|
| Baseline | Week 2 | Week 4 | Week 8 |
|---|
| Placebo | 14.9 | 12.4 | 11.6 | 11.3 |
,| Serlopitant | 13.7 | 11.6 | 11.4 | 10.6 |
Patient Benefit Index, Version for Patients With Pruritus (PBI-P)
"At Visits 2 and 5 (or Early termination) only, participants completed the standardized and validated PBI-P questionnaire. Prior to treatment, the first page of the questionnaire, the Patient Needs Questionnaire (PNQ), was administered to determine how different benefits of therapy were relevant for the individual participant. After treatment, using the Patient Benefit Questionnaire (PBQ), participants were asked to evaluate the extent to which the benefits they indicated were important to them were, in fact, realized. From all the items taken together, a weighted total benefit value was calculated, which represented the patient relevant therapy benefits. The mean score greater than 1 is considered to represent a clinically relevant improvement. The items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for does/did not apply to me = 5; and missing value = -9. Higher scores indicated better outcome." (NCT02196324)
Timeframe: At Week 8 / End of Treatment
| Intervention | Units on a scale (Mean) |
|---|
| Placebo | 0.81 |
| Serlopitant | 1.16 |
Worst Visual Analog Scale (VAS)
"At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of no itch (0 cm) and worst imaginable itch (10 cm). Worst VAS (worst itch over the past 24 hours) was recorded. Higher scores indicated worse outcome." (NCT02196324)
Timeframe: At Baseline, Weeks 2, 4, and 8
| Intervention | Units on a scale (Mean) |
|---|
| Baseline | Week 2 | Week 4 | Week 8 |
|---|
| Placebo | 8.75 | 7.92 | 7.46 | 6.73 |
,| Serlopitant | 8.43 | 6.85 | 6.19 | 4.82 |
Average Visual Analog Scale at Week 4
"At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of no itch (0 cm) and worst imaginable itch (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome." (NCT02196324)
Timeframe: At Week 4
| Intervention | Units on a scale (Mean) |
|---|
| Placebo | 6.32 |
| Serlopitant | 5.41 |
Average Visual Analog Scale at Week 2
"At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of no itch (0 cm) and worst imaginable itch (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome." (NCT02196324)
Timeframe: At Week 2
| Intervention | Units on a scale (Mean) |
|---|
| Placebo | 7.01 |
| Serlopitant | 6.06 |
Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)
"Using the IGA, physicians rated change in PN lesions (if any) from +5 (markedly improved) to -5 (markedly worse). Higher scores indicated better outcome." (NCT02196324)
Timeframe: At Week 8
| Intervention | Participants (Count of Participants) |
|---|
| Markedly Improved | Largely Improved | Moderately To Largely Improved | Moderately Improved | Mildly Improved | Baseline | Mildly Worse | Moderately Worse | Moderately To Largely Worse | Largely Worse |
|---|
| Placebo | 0 | 2 | 4 | 4 | 9 | 14 | 8 | 4 | 1 | 1 |
,| Serlopitant | 4 | 3 | 3 | 11 | 17 | 7 | 5 | 4 | 1 | 2 |
Average Visual Analog Scale at Baseline
"At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of no itch (0 cm) and worst imaginable itch (10 cm). Average Visual Analog Scale (VAS) (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome." (NCT02196324)
Timeframe: At Baseline
| Intervention | Units on a scale (Mean) |
|---|
| Placebo | 7.92 |
| Serlopitant | 7.88 |
Pruritus-specific Quality of Life (ItchyQoL)
"At each visit, participants completed an ItchyQoL questionnaire. The ItchyQoL is a validated questionnaire consisting of 22 questions based on the concerns and issues pertinent to participants with pruritus.~Items should be scored for the following answers:~Never: 1, Rarely: 2, Sometimes: 3, Often: 4, All the time:5. Higher scores indicated worse outcome. Total Score is obtained by calculating the unweighted mean of all ItchyQoL questions." (NCT02196324)
Timeframe: At Baseline, Weeks 2, 4, and 8
| Intervention | Units on a scale (Mean) |
|---|
| Baseline | Week 2 | Week 4 | Week 8 |
|---|
| Placebo | 3.68 | 3.50 | 3.36 | 3.33 |
,| Serlopitant | 3.52 | 3.36 | 3.26 | 3.09 |
Participants With Rescue Medication Usage
Rescue medications included cetirizine hydrochloride, desloratadine, levocetirizine, and loratadine. (NCT02196324)
Timeframe: Pre-treatment, upto 8 Weeks
| Intervention | Participants (Count of Participants) |
|---|
| Pre-treatment Rescue Medication Used | Used Rescue Medication |
|---|
| Placebo | 15 | 12 |
,| Serlopitant | 17 | 8 |
Numeric Rating Scale (NRS)
Numeric Rating Scale: Using the patient diary, participants rated the following using an 11-point NRS (0 = no itching; to 10 = worst itch imaginable): average itching over the past 24 hours (Average NRS). Higher scores indicated worse outcome. (NCT02196324)
Timeframe: At Baseline, Weeks 2, 4, and 8
| Intervention | Units on a scale (Mean) |
|---|
| Baseline | Week 2 | Week 4 | Week 8 |
|---|
| Placebo | 7.65 | 6.23 | 5.80 | 5.11 |
,| Serlopitant | 7.60 | 5.50 | 4.91 | 4.02 |
Number of Participants With Improvement on Prurigo Activity Score (PAS)
"Using the PAS, physicians described, localized, counted, and measured PN lesions.~One of the 7 items was:~Activity Stage (Stage 0-4: 0 = 0%, 1 = 1-25%, 2 = 26-50%, 3 = 51-75%, 4 = > 75%)~a. Prurigo lesions with excoriations/crusts~Participants with PAS activity stage (prurigo lesions with excoriations/crusts) is presented in the below table." (NCT02196324)
Timeframe: At Day 1 and Week 8
| Intervention | Participants (Count of Participants) |
|---|
| Day 1, 1 - 25 % | Day 1, 26 - 50 % | Day 1, 51 - 75 % | Day 1, >75 % | Week 8, 0 % | Week 8, 1 - 25 % | Week 8, 26 - 50 % | Week 8, 51 - 75 % | Week 8, >75 % |
|---|
| Placebo | 7 | 18 | 17 | 21 | 0 | 11 | 12 | 11 | 13 |
,| Serlopitant | 5 | 19 | 19 | 21 | 4 | 15 | 12 | 11 | 15 |
Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus
At study visits, participants used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present). Higher scores indicated worse outcome. (NCT02196324)
Timeframe: At Baseline and Week 8
| Intervention | Participants (Count of Participants) |
|---|
| Baseline, Mild Present | Baseline, Moderately Present | Baseline, Severely Present | Baseline, Very Severely Present | Week 8, Not Present | Week 8, Mild Present | Week 8, Moderately Present | Week 8, Severely Present | Week 8, Very Severely Present |
|---|
| Placebo | 2 | 18 | 20 | 22 | 2 | 11 | 18 | 9 | 5 |
,| Serlopitant | 0 | 17 | 32 | 15 | 4 | 27 | 17 | 7 | 2 |
Number of Participants With Improvement in Pruritus as Reported on Patient Global Assessment (PGA)
The PGA included a question: Did the pruritus improve during the treatment period (yes/no). (NCT02196324)
Timeframe: At Weeks 2, 4, and 8
| Intervention | Participants (Count of Participants) |
|---|
| Week 2 | Week 4 | Week 8 |
|---|
| Placebo | 23 | 29 | 25 |
,| Serlopitant | 37 | 43 | 47 |
Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging
At study visits, participants used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present). Higher scores indicated worse outcome. (NCT02196324)
Timeframe: At Baseline and Week 8
| Intervention | Participants (Count of Participants) |
|---|
| Baseline, Not Present | Baseline, Mild Present | Baseline, Moderately Present | Baseline, Severely Present | Baseline, Very Severely Present | Week 8, Not Present | Week 8, Mild Present | Week 8, Moderately Present | Week 8, Severely Present | Week 8, Very Severely Present |
|---|
| Placebo | 26 | 8 | 11 | 9 | 8 | 18 | 8 | 10 | 4 | 3 |
,| Serlopitant | 21 | 14 | 16 | 10 | 3 | 30 | 12 | 7 | 4 | 1 |
Wound Healing Determination
Wound dimensions, including length, width, and area (in cm2), will be obtained using the Canfield system. Changes in dimensions between visits as well as changes in dimensions from baseline will be recorded. Overall mean % change from baseline is reported as the secondary endpoint. (NCT02654483)
Timeframe: Baseline and 8 weeks
| Intervention | percentage change (Mean) |
|---|
| 5 mg VPD-737 | 154.54 |
| Placebo | 38.39 |
Change in Mean NRS Itch Score During Bathing/Dressing Changes
"Itch is exacerbated by activities such as dressing changes or bathing. NRS itch score during bathing or dressing in the past 24 hours were collected. Numeric rating scale (NRS) for itch severity is comprised of one item and represents the numbers 0 (no itch) to 10 (worst imaginable itch). This study was designed to detect differences between the two treatment groups. This secondary endpoint was the comparative change in Numeric Rating Scale (NRS) itch severity score during bathing/dressing changes from baseline over 8 weeks as determined by application of a linear mixed effects model." (NCT02654483)
Timeframe: Baseline and 8 weeks
| Intervention | score on a scale (Mean) |
|---|
| 5 mg VPD-737 | -2.5 |
| Placebo | -2 |
Comparative Weekly Change in NRS Itch Score Over the 8-week Active Treatment Period
"Determine the efficacy of Serlopitant compared with placebo on reducing EB-associated daily itch score as measured by patient self-reports using a numeric rating scale (NRS) for itch severity.The NRS is comprised of one item and represents the numbers 0 (no itch) to 10 (worst imaginable itch). Because itch is subjective and can vary day to day, nightly NRS scores were recorded in patients' Itch Diaries. NRS recorded by subject daily, from screening visit through the end of the study.~This study was designed to detect differences between the two treatment groups. The primary endpoint was the comparative weekly change in Numeric Rating Scale (NRS) itch severity score from baseline over 8 weeks; derived from a linear mixed effects model which utilizes observations from both the treatment and placebo groups to generate an interaction term of interest. Itch severity changes from day to day and this model can more appropriately report trends in patients' itch severity with treatment." (NCT02654483)
Timeframe: Baseline and 8 weeks
| Intervention | score/week comparative change (Mean) |
|---|
| 5 mg VPD-737 | -2 |
| Placebo | -1 |
Change in Quality of Life (ItchyQoL) From Baseline to Week 6
ItchyQoL is a 22-item pruritus-specific instrument that measures the degree to which pruritus affects quality-of-life. The responses to the items are Never (1), Rarely (2), Sometimes (3), Often (4) and All the Time (5). A higher score corresponds to a more adverse impact. The overall score is the average of the 22 items ranging from 1 to 5. (NCT02975206)
Timeframe: Week 6 compared to Baseline
| Intervention | score on a scale (Mean) |
|---|
| Serlopitant 5 mg | -0.57 |
| Serlopitant 1 mg | -0.58 |
| Placebo Oral Tablet | -0.53 |
Change in WI-NRS From Baseline to Week 6
Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline. (NCT02975206)
Timeframe: Week 6 compared to Baseline
| Intervention | score on a scale (Mean) |
|---|
| Serlopitant 5 mg | -2.25 |
| Serlopitant 1 mg | -2.32 |
| Placebo Oral Tablet | -2.01 |
WI-NRS 4-point Responder Rate at Week 6
Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Week 6 and baseline. (NCT02975206)
Timeframe: Week 6 compared to Baseline
| Intervention | Participants (Count of Participants) |
|---|
| Serlopitant 5 mg | 33 |
| Serlopitant 1 mg | 36 |
| Placebo Oral Tablet | 26 |
Change in Awake Objective Cough Frequency
Awake cough frequency = (total number of cough events during the monitoring period (24-hour interval) the subject is awake)/(Total duration (in hours) for the monitoring period the subject is awake) which is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd). (NCT03282591)
Timeframe: from Baseline to Day 84
| Intervention | coughs/hr (Least Squares Mean) |
|---|
| Day 28 (Week 4) | Day 56 (Week 8) | Day 84 (Week 12) |
|---|
| Placebo | -0.30 | -0.32 | -0.46 |
,| Serlopitant 5 mg | -0.12 | -0.25 | -0.19 |
Change From Baseline in Cough Severity Visual Analog Scale (VAS)
Visual Analog Scale (VAS) 101-point scale ranging from 0 (no cough) to 100 (worst cough). A higher score corresponds to higher cough severity. (NCT03282591)
Timeframe: from Baseline to Day 84
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Day 28 (Week 4) | Day 56 (Week 8) | Day 84 (Week 12) |
|---|
| Placebo | -9.9 | -7.4 | -9.9 |
,| Serlopitant 5 mg | -10.2 | -14.6 | -14.2 |
Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency
The percentage of participants with ≥ 30% of reduction from baseline in the awake cough frequency is the number of participants with ≤30% change in awake cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd). (NCT03282591)
Timeframe: from Baseline to Day 84
| Intervention | percentage of participants (Number) |
|---|
| Serlopitant 5 mg | 32.6 |
| Placebo | 37.0 |
Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency
The percentage of participants with ≥ 30% of reduction from baseline in 24-hour cough frequency is the number of participants with ≤-30% change in 24-hour cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd). (NCT03282591)
Timeframe: from Baseline to Day 84
| Intervention | Percentage of participants (Number) |
|---|
| Serlopitant 5 mg | 71.4 |
| Placebo | 90.2 |
Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo)
Change in 24-hour objective cough frequency is total number of cough events during the monitoring period (24-hour interval)/24 (Total duration (in hours) for the monitoring period) which is captured through sound recordings by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd). (NCT03282591)
Timeframe: from Baseline to Day 84
| Intervention | coughs/hr (Least Squares Mean) |
|---|
| Serlopitant 5 mg | -0.18 |
| Placebo | -0.45 |
Change in WI-NRS From Baseline to Day 3
Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The secondary outcome is the change in WI-NRS score at 3 days compared with Baseline. (NCT03343639)
Timeframe: 3 days
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Serlopitant 5 mg | -0.702 |
| Placebo | -0.461 |
WI-NRS 4-point Responder Rate at Week 4
Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Baseline and Week 4. (NCT03343639)
Timeframe: 4 weeks
| Intervention | percentage of subjects (Number) |
|---|
| Serlopitant 5 mg | 20.78 |
| Placebo | 11.49 |
WI-NRS 4-point Responder Rate at Week 8
Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Baseline and Week 8. (NCT03343639)
Timeframe: 8 weeks
| Intervention | % of subjects (incl. imputed data) (Number) |
|---|
| Serlopitant 5 mg | 33.29 |
| Placebo | 21.07 |
Change in WI-NRS From Baseline to Day 7
Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The secondary outcome is the change in WI-NRS score at 7 days compared with Baseline. (NCT03343639)
Timeframe: Change from baseline to day 7
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Serlopitant 5 mg | -1.307 |
| Placebo | -0.785 |
Number of Subjects With Treatment-emergent Adverse Events
Treatments emergent adverse events (TEAEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected. (NCT03540160)
Timeframe: From baseline until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 52 visit or the last dose of study drug for subjects who discontinued study drug early.
| Intervention | Participants (Count of Participants) |
|---|
| Subjects with any TEAE | Subjects with any related TEAE | Subjects with any SAE | Subjects with any related SAE | Subjects who died | Subjects who discontinued study drug due to TEAE |
|---|
| Serlopitant 5 mg | 325 | 55 | 45 | 1 | 0 | 28 |
Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10
During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. For the 3-point responder rate, subjects were considered responders if they had at least a 3-point reduction between baseline and the corresponding week. (NCT03546816)
Timeframe: At Weeks 2, 4, and 10
| Intervention | Percentage of subjects (Number) |
|---|
| Percentage of responders at Week 2 | Percentage of responders at Week 4 | Percentage of responders at Week 10 |
|---|
| Placebo | 9.27 | 14.31 | 27.83 |
,| Serlopitant 5 mg | 14.79 | 23.32 | 35.58 |
Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs)
Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected. (NCT03546816)
Timeframe: 35 days (+3 days) after Week 10 or Early Treatment Discontinuation
| Intervention | Participants (Count of Participants) |
|---|
| Subjects with any TEAE | Subjects with any Related TEAE | Subjects with any Serious TEAE | Subjects with any Related Serious TEAE | Subjects who Died | Subjects who discontinued drug due to TEAE |
|---|
| Placebo | 64 | 9 | 3 | 0 | 0 | 3 |
,| Serlopitant 5 mg | 74 | 20 | 6 | 0 | 0 | 5 |
Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10
During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. (NCT03546816)
Timeframe: At Weeks 2, 4, 6, and 10
| Intervention | Score on a scale (Mean) |
|---|
| Change from Baseline at Week 2 | Change from Baseline at Week 4 | Change from Baseline at Week 6 | Change from Baseline at Week 10 |
|---|
| Placebo | -0.96 | -1.32 | -1.65 | -2.06 |
,| Serlopitant 5 mg | -1.30 | -1.82 | -2.13 | -2.47 |
Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10
The IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis. (NCT03546816)
Timeframe: At Weeks 2, 4, and 10
| Intervention | Score on a scale (Mean) |
|---|
| Change from Baseline to Week 2 | Change from Baseline to Week 4 | Change from Baseline to Week 10 |
|---|
| Placebo | -0.1 | -0.3 | -0.4 |
,| Serlopitant 5 mg | -0.2 | -0.4 | -0.5 |
Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. Subjects were considered responders if they had at least a 4-point reduction from baseline in weekly average WI-NRS at Week 10. (NCT03546816)
Timeframe: At Week 10
| Intervention | Percentage of subjects (Number) |
|---|
| Serlopitant 5 mg | 26.45 |
| Placebo | 20.31 |
Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10
The IGA PN-A is an instrument used to assess the overall activity of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis. (NCT03546816)
Timeframe: At Weeks 2, 4, and 10
| Intervention | Score on a scale (Mean) |
|---|
| Change from Baseline at Week 2 | Change from Baseline at Week 4 | Change from Baseline at Week 10 |
|---|
| Placebo | -0.3 | -0.4 | -0.6 |
,| Serlopitant 5 mg | -0.3 | -0.6 | -0.7 |
Percent of Subjects With WI-NRS 4-point Responder at Week 4
During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. (NCT03546816)
Timeframe: At Week 4
| Intervention | Percentage of subjects (Number) |
|---|
| Serlopitant 5 mg | 17.66 |
| Placebo | 7.80 |
Percent of Subjects With WI-NRS 4-point Responder at Week 2
During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. (NCT03546816)
Timeframe: At Week 2
| Intervention | Percentage of subjects (Number) |
|---|
| Serlopitant 5 mg | 8.45 |
| Placebo | 4.93 |
Change From Baseline in DLQI Question 1 to Week 10
DLQI is a dermatology specific QoL instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment) The DLQI question 1 is to measure how itchy, sore, painful or stinging the subject's skin had been. It is rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL. (NCT03546816)
Timeframe: At Week 10
| Intervention | Score on a scale (Mean) |
|---|
| Serlopitant 5 mg | -0.8 |
| Placebo | -0.6 |
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10
Dermatology Life Quality Index (DLQI) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment). The DLQI questions are rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL. (NCT03546816)
Timeframe: At Week 10
| Intervention | Score on a scale (Mean) |
|---|
| Serlopitant 5 mg | -4.1 |
| Placebo | -4.3 |
Percent of Participants With WI-NRS 4-point Responder Rate at Week 4
During the study, WI-NRS assessments were reported by the participant via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4). (NCT03677401)
Timeframe: At Week 4
| Intervention | percentage of participants (Number) |
|---|
| Success | Failure |
|---|
| Placebo | 11.49 | 88.51 |
,| Serlopitant 5 mg | 12.63 | 87.37 |
Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10
During the study, WI-NRS assessments were reported by the participant via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4). (NCT03677401)
Timeframe: At Week 10
| Intervention | Percentage of participants (Number) |
|---|
| Success | Failure |
|---|
| Placebo | 18.95 | 81.05 |
,| Serlopitant 5 mg | 25.90 | 74.10 |
Percent of Participants With WI-NRS 4-point Responder Rate at Week 2
During the study, WI-NRS assessments were reported by the participant via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4). (NCT03677401)
Timeframe: At Week 2
| Intervention | percentage of participants (Number) |
|---|
| Success | Failure |
|---|
| Placebo | 6.76 | 93.24 |
,| Serlopitant 5 mg | 5.55 | 94.45 |
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10
Dermatology Life Quality Index (DLQI) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the skin disease on a participant's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment). The DLQI questions are rated by the participant as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.). (NCT03677401)
Timeframe: At Week 10
| Intervention | Score on a scale (Mean) |
|---|
| Placebo | -4.4 |
| Serlopitant 5 mg | -4.5 |
Change From Baseline in DLQI Question 1 to Week 10
Dermatology Life Quality Index (DLQI) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the skin disease on a participant's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment). The DLQI questions are rated by the participant as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.). (NCT03677401)
Timeframe: At Week 10
| Intervention | Score on a scale (Mean) |
|---|
| Placebo | -0.6 |
| Serlopitant 5 mg | -0.6 |
Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10
The IGA PN-A is an instrument used to assess the overall activity of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis. (NCT03677401)
Timeframe: At Weeks 2, 4, and 10
| Intervention | Score on a scale (Mean) |
|---|
| Change from Baseline at Week 2 | Change from Baseline at Week 4 | Change from Baseline at Week 10 |
|---|
| Placebo | -0.2 | -0.5 | -0.7 |
,| Serlopitant 5 mg | -0.3 | -0.5 | -0.7 |
Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Stage (IGA PN-S) to Weeks 2, 4, and 10
The IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis. (NCT03677401)
Timeframe: At Weeks 2, 4 and 10
| Intervention | Score on a scale (Mean) |
|---|
| Change from Baseline at Week 2 | Change from Baseline at Week 4 | Change from Baseline at Week 10 |
|---|
| Placebo | -0.2 | -0.4 | -0.5 |
,| Serlopitant 5 mg | -0.2 | -0.3 | -0.5 |
Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10
During the study, WI-NRS assessments were reported by the participant via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. (NCT03677401)
Timeframe: At Weeks 2, 4, 6, and 10
| Intervention | Score on a scale (Mean) |
|---|
| Change from Baseline at Week 2 | Change from Baseline at Week 4 | Change from Baseline at Week 6 | Change from Baseline at Week 10 |
|---|
| Placebo | -0.94 | -1.42 | -1.61 | -1.86 |
,| Serlopitant 5 mg | -1.25 | -1.60 | -1.93 | -2.24 |
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs)
Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected. (NCT03677401)
Timeframe: From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for participants who discontinued study drug early
| Intervention | Participants (Count of Participants) |
|---|
| Participants with any TEAE | Participants with any related TEAE | Participants with any serious TEAE | Participants with any related serious TEAE | Participants who Died | Participants who discontinued study drug |
|---|
| Placebo | 87 | 24 | 2 | 0 | 0 | 4 |
,| Serlopitant 5 mg | 84 | 30 | 5 | 0 | 0 | 13 |
Percent of Participants With WI-NRS 3-point Responder at Weeks 2, 4, and 10
During the study, WI-NRS assessments were reported by the participant via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3). (NCT03677401)
Timeframe: At Weeks 2, 4, and 10
| Intervention | Percentage of participants (Number) |
|---|
| Percentage of responders at Week 2 | Percentage of responders at Week 4 | Percentage of responders at Week 10 |
|---|
| Placebo | 8.11 | 18.24 | 25.65 |
,| Serlopitant 5 mg | 11.89 | 20.03 | 37.58 |
Weekly AI-NRS
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching. (NCT03836001)
Timeframe: baseline and week 1, 2, 3, 4, 5, 6, 7, and 8
| Intervention | score on a scale (Mean) |
|---|
| baseline | week 1 | week 2 | week 3 | week 4 | week 5 | week 6 | week 7 | week 8 |
|---|
| Placebo Oral Tablet | 5.3 | 5.1 | 5.3 | 5.5 | 5.4 | 5.2 | 5.0 | 4.8 | 4.8 |
,| Serlopitant Tablet | 6.3 | 5.6 | 5.6 | 5.2 | 5.2 | 5.1 | 5.1 | 5.2 | 5.0 |
Weekly Worst Itch NRS
Participants will be asked to complete a daily itch diary with their worst itch numeric rating scale (WI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching. (NCT03836001)
Timeframe: baseline and week 1, 2, 3, 4, 5, 6, 7, and 8
| Intervention | score on a scale (Mean) |
|---|
| baseline | week 1 | week 2 | week 3 | week 4 | week 5 | week 6 | week 7 | week 8 |
|---|
| Placebo Oral Tablet | 6.1 | 6.0 | 6.1 | 6.5 | 6.4 | 6.4 | 6.0 | 6.0 | 6.0 |
,| Serlopitant Tablet | 7.3 | 6.3 | 5.9 | 5.7 | 5.6 | 5.7 | 5.8 | 5.6 | 5.4 |
Patient Global Impression of Change (PGIC)
"PGIC categorized as Very much better, Moderately better, A little better, No change, A little worse, Moderately worse, and Very much worse." (NCT03836001)
Timeframe: month 2
| Intervention | Participants (Count of Participants) |
|---|
| Very much better | Moderately better | A little better | No change | A little worse | Moderately worse | Very much worse |
|---|
| Placebo Oral Tablet | 0 | 1 | 5 | 5 | 0 | 1 | 0 |
,| Serlopitant Tablet | 2 | 0 | 3 | 5 | 0 | 0 | 0 |
Dressing/Bathing NRS
Participants will be asked to complete a daily itch diary with their itch Numeric Rating Scale (NRS) during dressing/bathing. Score range: 0 to 10, higher scores mean more itching. (NCT03836001)
Timeframe: baseline and week 1, 2, 3, 4, 5, 6, 7, and 8
| Intervention | score on a scale (Mean) |
|---|
| baseline | week 1 | week 2 | week 3 | week 4 | week 5 | week 6 | week 7 | week 8 |
|---|
| Placebo Oral Tablet | 5.3 | 5.1 | 5.0 | 5.5 | 5.4 | 5.6 | 5.6 | 5.6 | 5.3 |
,| Serlopitant Tablet | 6.8 | 5.7 | 6.0 | 5.4 | 5.1 | 5.5 | 5.5 | 5.4 | 5.4 |
Change in Static Participant Assessment of Itch
"Severity of itch over past 7 days assessed as Very Severe, Severe, Moderate, Mild, or None.~Change is reported as the number of participants with 3-category improvement, 2-category improvement, 1-category improvement, no change, or worse." (NCT03836001)
Timeframe: month 2
| Intervention | Participants (Count of Participants) |
|---|
| 3-category improvement | 2-category improvement | 1-category improvement | No change | Worse |
|---|
| Placebo Oral Tablet | 0 | 0 | 2 | 3 | 0 |
,| Serlopitant Tablet | 1 | 1 | 0 | 2 | 0 |
Number of Patients Who Achieve at Least a 50% Reduction in AI-NRS.
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching. (NCT03836001)
Timeframe: baseline and after two months of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Placebo Oral Tablet | 1 |
| Serlopitant Tablet | 1 |
Number of Patients Who Achieve at Least a 4-point Reduction in AI-NRS.
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching. (NCT03836001)
Timeframe: baseline and after two months of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Placebo Oral Tablet | 1 |
| Serlopitant Tablet | 1 |
Number of Patients Who Achieve at Least a 30% Reduction in AI-NRS.
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching. (NCT03836001)
Timeframe: baseline and after two months of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Placebo Oral Tablet | 4 |
| Serlopitant Tablet | 3 |
Number of Patients Who Achieve at Least a 3-point Reduction in AI-NRS.
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching. (NCT03836001)
Timeframe: baseline and after two months of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Placebo Oral Tablet | 1 |
| Serlopitant Tablet | 3 |
Number of Patients Who Achieve at Least a 2-point Reduction in AI-NRS.
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching. (NCT03836001)
Timeframe: baseline and after two months of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Placebo Oral Tablet | 2 |
| Serlopitant Tablet | 3 |
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Adverse events (AEs) were recorded to assess the safety and tolerability of repeated oral doses of serlopitant in adult subjects with chronic pruritus of unknown origin. Adverse events (AEs) and SAEs were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected. (NCT03841331)
Timeframe: From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.
| Intervention | Participants (Count of Participants) |
|---|
| TEAEs | TEAEs Leading to Treatment Discontinuation | TEAEs Likely Related to Study Drug | Serious TEAEs |
|---|
| Placebo | 38 | 2 | 3 | 0 |
,| Serlopitant 5 mg | 49 | 2 | 12 | 2 |
WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8
"During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.~The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4)." (NCT03841331)
Timeframe: At Weeks 2, 4, 6, and 8
| Intervention | Participants (Count of Participants) |
|---|
| Responders at Week 2 | Responders at Week 4 | Responders at Week 6 | Responders at Week 8 |
|---|
| Placebo | 19 | 29 | 35 | 40 |
,| Serlopitant 5 mg | 18 | 24 | 38 | 37 |
WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10
"During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.~The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3). Results presented below is of subjects who were a 3-point responder but not a 4-point responder." (NCT03841331)
Timeframe: At Weeks 2, 4, 6, 8, and 10
| Intervention | Participants (Count of Participants) |
|---|
| Responders at Week 2 | Responders at Week 4 | Responders at Week 6 | Responders at Week 8 | Responders at Week 10 |
|---|
| Placebo | 6 | 8 | 15 | 14 | 13 |
,| Serlopitant 5 mg | 6 | 14 | 10 | 15 | 16 |
Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10
The Itch Visual Analog Scale (VAS) is a validated, self-reported instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the worst intensity of their itch on a 100-mm horizontal line ranging from 0 mm (no itch) to 100 mm (worst itch imaginable). Higher scores indicated greater itch intensity. The VAS measurement were summarized in centimeters. WI-VAS assessments were reported by the subject via a paper form administered at study visits. (NCT03841331)
Timeframe: At Weeks 2, 4, 6, and 10
| Intervention | score on a scale (Mean) |
|---|
| Baseline (Observed Value) | Change from Baseline at Week 2 | Change from Baseline at Week 4 | Change from Baseline at Week 6 | Change from Baseline at Week 10 |
|---|
| Placebo | 82.09 | -22.96 | -27.01 | -32.83 | -37.64 |
,| Serlopitant 5 mg | 83.53 | -20.52 | -28.28 | -30.92 | -37.42 |
Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10
"During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.~The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity." (NCT03841331)
Timeframe: At Weeks 2, 4, 6, 8, and 10
| Intervention | score on a scale (Mean) |
|---|
| Baseline (Observed value) | Change from Baseline at Week 2 | Change from Baseline at Week 4 | Change from Baseline at Week 6 | Change from Basline at Week 8 | Change from Baseline at Week 10 |
|---|
| Placebo | 8.37 | -1.65 | -2.41 | -2.83 | -2.99 | -3.34 |
,| Serlopitant 5 mg | 8.44 | -1.61 | -2.46 | -2.94 | -2.97 | -3.25 |
Change From Baseline in Daily WI-NRS Scores Through Week 2
"During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.~The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity." (NCT03841331)
Timeframe: Through 2 weeks
| Intervention | score on a scale (Mean) |
|---|
| Baseline (observed value) | Change from Baseline at Day 1 | Change from Baseline at Day 2 | Change from Baseline at Day 3 | Change from Baseline at Day 4 | Change from Baseline at Day 5 | Change from Baseline at Day 6 | Change from Baseline at Day 7 | Change from Baseline at Day 8 | Change from Baseline at Day 9 | Change from Baseline at Day 10 | Change from Baseline at Day 11 | Change from Baseline at Day 12 | Change from Baseline at Day 13 | Change from Baseline at Day 14 |
|---|
| Placebo | 8.37 | -0.22 | -0.85 | -0.94 | -1.16 | -1.34 | -1.33 | -1.44 | -1.35 | -1.53 | -1.63 | -1.73 | -1.67 | -1.82 | -1.92 |
,| Serlopitant 5 mg | 8.44 | -0.09 | -0.69 | -0.77 | -0.96 | -0.99 | -1.15 | -1.35 | -1.35 | -1.35 | -1.41 | -1.69 | -1.58 | -1.75 | -1.74 |
Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10
"During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.~The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4)." (NCT03841331)
Timeframe: At Week 10
| Intervention | Participants (Count of Participants) |
|---|
| Placebo | 46 |
| Serlopitant 5 mg | 44 |