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Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03546816
Recruitment Status : Completed
First Posted : June 6, 2018
Results First Posted : September 7, 2020
Last Update Posted : May 20, 2021
Sponsor:
Information provided by (Responsible Party):
Vyne Therapeutics Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Pruritus
Prurigo Nodularis
Interventions Drug: 5mg Serlopitant Tablets
Drug: Placebo Tablets
Enrollment 285
Recruitment Details The study was conducted at 49 sites in United States from 02 May 2018 to 14 February 2020. All subjects who met the study entry criteria were randomized in a 1:1 ratio to receive once-daily oral doses of serlopitant 5 mg or placebo for 10 weeks.
Pre-assignment Details During the screening period (2-4 weeks), all subjects were evaluated for eligibility and assessed for conditions associated with chronic pruritus. Subjects were to complete an electronic diary (eDiary) during screening visit.
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description Randomized subjects received serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day. Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Period Title: Overall Study
Started 142 143
Completed 121 124
Not Completed 21 19
Reason Not Completed
Adverse Event             5             3
Lack of Efficacy             2             4
Pregnancy             1             0
Physician Decision             2             0
Withdrawal by Subject             8             10
Lost to Follow-up             3             2
Arm/Group Title Serlopitant 5 mg Placebo Total
Hide Arm/Group Description Randomized subjects received serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day. Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day. Total of all reporting groups
Overall Number of Baseline Participants 142 143 285
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 139 participants 141 participants 280 participants
58.7  (13.54) 56.0  (12.99) 57.4  (13.30)
[1]
Measure Analysis Population Description: Three subjects were excluded in the serlopitant 5 mg arm and 2 subjects were excluded in the placebo arm due to no evidence of subject dosing and/or no post-Baseline assessment/treatment emergent adverse event (TEAE).
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants 141 participants 280 participants
Female
92
  66.2%
89
  63.1%
181
  64.6%
Male
47
  33.8%
52
  36.9%
99
  35.4%
[1]
Measure Analysis Population Description: Three subjects were excluded in the serlopitant 5 mg arm and 2 subjects were excluded in the placebo arm due to no evidence of subject dosing and/or no post-Baseline assessment/TEAE.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants 141 participants 280 participants
American Indian or Alaska Native
1
   0.7%
0
   0.0%
1
   0.4%
Asian
6
   4.3%
11
   7.8%
17
   6.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.7%
1
   0.4%
Black or African American
27
  19.4%
33
  23.4%
60
  21.4%
White
102
  73.4%
91
  64.5%
193
  68.9%
More than one race
3
   2.2%
5
   3.5%
8
   2.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Three subjects were excluded in the serlopitant 5 mg arm and 2 subjects were excluded in the placebo arm due to no evidence of subject dosing and/or no post-Baseline assessment/TEAE.
1.Primary Outcome
Title Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10
Hide Description 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.
Time Frame At Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description:
Randomized subjects received Serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Overall Number of Participants Analyzed 142 142
Measure Type: Number
Unit of Measure: Percentage of subjects
26.45 20.31
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.229
Comments P-value from a Cochran-Mantel-Haenszel (CMH) test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Percent of Subjects With WI-NRS 4-point Responder at Week 4
Hide Description 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.
Time Frame At Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description:
Randomized subjects received Serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day on an outpatient basis.
Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day on an outpatient basis.
Overall Number of Participants Analyzed 142 142
Measure Type: Number
Unit of Measure: Percentage of subjects
17.66 7.80
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Percent of Subjects With WI-NRS 4-point Responder at Week 2
Hide Description 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.
Time Frame At Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description:
Randomized subjects received Serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Overall Number of Participants Analyzed 142 142
Measure Type: Number
Unit of Measure: Percentage of subjects
8.45 4.93
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.236
Comments P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10
Hide Description 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.
Time Frame At Weeks 2, 4, 6, and 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description:
Randomized subjects received Serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Overall Number of Participants Analyzed 142 142
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Change from Baseline at Week 2 -1.30  (1.725) -0.96  (1.740)
Change from Baseline at Week 4 -1.82  (2.226) -1.32  (2.248)
Change from Baseline at Week 6 -2.13  (2.436) -1.65  (2.460)
Change from Baseline at Week 10 -2.47  (2.633) -2.06  (2.612)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments At Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.083
Comments P-values, least squares means (LS Mean) and standard deviations (LS SD) from an analysis of covariance (ANCOVA) with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments At Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments At Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.081
Comments P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments At Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.157
Comments P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10
Hide Description 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.
Time Frame At Weeks 2, 4, and 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description:
Randomized subjects received Serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Overall Number of Participants Analyzed 142 142
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of responders at Week 2 14.79 9.27
Percentage of responders at Week 4 23.32 14.31
Percentage of responders at Week 10 35.58 27.83
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments At Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.151
Comments P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments At Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments At Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10
Hide Description 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.
Time Frame At Weeks 2, 4, and 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description:
Randomized subjects received Serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Overall Number of Participants Analyzed 142 142
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Change from Baseline at Week 2 -0.3  (0.71) -0.3  (0.71)
Change from Baseline at Week 4 -0.6  (0.81) -0.4  (0.81)
Change from Baseline at Week 10 -0.7  (0.99) -0.6  (0.99)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments At Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.475
Comments P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments At Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments At Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.492
Comments P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10
Hide Description 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.
Time Frame At Weeks 2, 4, and 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description:
Randomized subjects received Serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Overall Number of Participants Analyzed 142 142
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Change from Baseline to Week 2 -0.2  (0.52) -0.1  (0.52)
Change from Baseline to Week 4 -0.4  (0.71) -0.3  (0.71)
Change from Baseline to Week 10 -0.5  (0.86) -0.4  (0.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments At Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments At Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.169
Comments P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments At Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.516
Comments P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10
Hide Description 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.
Time Frame At Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description:
Randomized subjects received Serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Overall Number of Participants Analyzed 142 142
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-4.1  (5.20) -4.3  (5.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments At Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.814
Comments P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in DLQI Question 1 to Week 10
Hide Description 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.
Time Frame At Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description:
Randomized subjects received Serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Overall Number of Participants Analyzed 142 142
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-0.8  (0.80) -0.6  (0.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serlopitant 5 mg, Placebo
Comments At Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
10.Secondary Outcome
Title Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame 35 days (+3 days) after Week 10 or Early Treatment Discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: included all treated subjects with at least one post-baseline assessment or a reported TEAE.
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description:
Randomized subjects received Serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
Overall Number of Participants Analyzed 139 141
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects with any TEAE
74
  53.2%
64
  45.4%
Subjects with any Related TEAE
20
  14.4%
9
   6.4%
Subjects with any Serious TEAE
6
   4.3%
3
   2.1%
Subjects with any Related Serious TEAE
0
   0.0%
0
   0.0%
Subjects who Died
0
   0.0%
0
   0.0%
Subjects who discontinued drug due to TEAE
5
   3.6%
3
   2.1%
Time Frame 35 days (+3 days) after Week 10 or Early Treatment Discontinuation
Adverse Event Reporting Description 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.
 
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description Randomized subjects received serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day. Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
All-Cause Mortality
Serlopitant 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/139 (0.00%)   0/141 (0.00%) 
Hide Serious Adverse Events
Serlopitant 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   6/139 (4.32%)   3/141 (2.13%) 
Gastrointestinal disorders     
Haematochezia * 1  1/139 (0.72%)  0/141 (0.00%) 
Infections and infestations     
Pneumonia * 1  1/139 (0.72%)  0/141 (0.00%) 
Abscess limb * 1  0/139 (0.00%)  1/141 (0.71%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc degeneration * 1  0/139 (0.00%)  1/141 (0.71%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous * 1  1/139 (0.72%)  0/141 (0.00%) 
Psychiatric disorders     
Schizoaffective disorder * 1  1/139 (0.72%)  0/141 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  1/139 (0.72%)  0/141 (0.00%) 
Acute respiratory failure * 1  1/139 (0.72%)  0/141 (0.00%) 
Surgical and medical procedures     
Knee arthroplasty * 1  0/139 (0.00%)  1/141 (0.71%) 
Vascular disorders     
Peripheral arterial occlusive disease * 1  1/139 (0.72%)  0/141 (0.00%) 
1
Term from vocabulary, MedDRA v21.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Serlopitant 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   18/141 (12.77%)   5/139 (3.60%) 
Infections and infestations     
Upper respiratory tract infection * 1  10/141 (7.09%)  3/139 (2.16%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  9/141 (6.38%)  2/139 (1.44%) 
1
Term from vocabulary, MedDRA v21.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Iain Stuart, PhD
Organization: Menlo Therapeutics Inc.
Phone: 1- 800-775-7936
EMail: Iain.Stuart@foamix.com
Layout table for additonal information
Responsible Party: Vyne Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03546816    
Other Study ID Numbers: MTI-105
First Submitted: May 23, 2018
First Posted: June 6, 2018
Results First Submitted: August 18, 2020
Results First Posted: September 7, 2020
Last Update Posted: May 20, 2021