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

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ClinicalTrials.gov Identifier: NCT03343639
Recruitment Status : Completed
First Posted : November 17, 2017
Results First Posted : June 12, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Menlo 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
Psoriasis
Interventions Drug: 5 mg Serlopitant Tablets
Drug: Matching Placebo Tablets
Enrollment 204
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description Subjects received a 3-tablet oral loading dose (15 mg) on the first day of the treatment period followed by a 5 mg dose of Serlopitant taken once daily by mouth for 8 weeks Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a Placebo tablet taken once daily by mouth for 8 weeks
Period Title: Overall Study
Started 102 102
Completed 88 90
Not Completed 14 12
Reason Not Completed
Withdrawal by Subject             10             6
Lost to Follow-up             4             5
Protocol Violation             0             1
Arm/Group Title Serlopitant 5 mg Placebo Total
Hide Arm/Group Description Subjects received a 3-tablet oral loading dose (15 mg) on the first day of the treatment period followed by a 5 mg dose of Serlopitant taken once daily by mouth for 8 weeks Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a Placebo tablet taken once daily by mouth for 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 102 101 203
Hide Baseline Analysis Population Description
The populations here represent the Full Analysis Set, not all randomized subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 101 participants 203 participants
48.2  (15.2) 46.7  (12.34) 47.5  (13.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 101 participants 203 participants
Female
48
  47.1%
62
  61.4%
110
  54.2%
Male
54
  52.9%
39
  38.6%
93
  45.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 101 participants 203 participants
Hispanic or Latino
29
  28.4%
31
  30.7%
60
  29.6%
Not Hispanic or Latino
73
  71.6%
70
  69.3%
143
  70.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 101 participants 203 participants
American Indian or Alaska Native
1
   1.0%
0
   0.0%
1
   0.5%
Asian
3
   2.9%
4
   4.0%
7
   3.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.0%
1
   0.5%
Black or African American
12
  11.8%
6
   5.9%
18
   8.9%
White
84
  82.4%
89
  88.1%
173
  85.2%
More than one race
2
   2.0%
1
   1.0%
3
   1.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 102 participants 101 participants 203 participants
102 101 203
WI-NRS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 102 participants 101 participants 203 participants
8.303  (1.0277) 8.082  (1.0588) 8.193  (1.0466)
[1]
Measure Description: 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. Subject-reported score from reflection on past 24 hours. The baseline was established by averaging 7 daily scores leading up to randomization.
1.Primary Outcome
Title WI-NRS 4-point Responder Rate at Week 8
Hide Description 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.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
These figures represent full analysis set.
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description:
Subjects received a 3-tablet oral loading dose (15 mg) on the first day of the treatment period followed by a 5 mg dose of Serlopitant taken once daily by mouth for 8 weeks
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a Placebo tablet taken once daily by mouth for 8 weeks
Overall Number of Participants Analyzed 102 101
Measure Type: Number
Unit of Measure: % of subjects (incl. imputed data)
33.29 21.07
2.Secondary Outcome
Title WI-NRS 4-point Responder Rate at Week 4
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
These figures represent full analysis set
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description:
Subjects received a 3-tablet oral loading dose (15 mg) on the first day of the treatment period followed by a 5 mg dose of Serlopitant taken once daily by mouth for 8 weeks
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a Placebo tablet taken once daily by mouth for 8 weeks
Overall Number of Participants Analyzed 102 101
Measure Type: Number
Unit of Measure: percentage of subjects
20.78 11.49
3.Secondary Outcome
Title Change in WI-NRS From Baseline to Day 7
Hide Description 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.
Time Frame Change from baseline to day 7
Hide Outcome Measure Data
Hide Analysis Population Description
These figures represent full analysis set
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description:
Subjects received a 3-tablet oral loading dose (15 mg) on the first day of the treatment period followed by a 5 mg dose of Serlopitant taken once daily by mouth for 8 weeks
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a Placebo tablet taken once daily by mouth for 8 weeks
Overall Number of Participants Analyzed 102 101
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.307  (1.8741) -0.785  (1.8391)
4.Secondary Outcome
Title Change in WI-NRS From Baseline to Day 3
Hide Description 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.
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
These figures represent full analysis set.
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description:
Subjects received a 3-tablet oral loading dose (15 mg) on the first day of the treatment period followed by a 5 mg dose of Serlopitant taken once daily by mouth for 8 weeks
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a Placebo tablet taken once daily by mouth for 8 weeks
Overall Number of Participants Analyzed 102 101
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.702  (1.4111) -0.461  (1.4060)
Time Frame Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the Follow-up visit, for a total of approximately 10 weeks.
Adverse Event Reporting Description The safety population is a subset of participants who received at least one dose of study medication with at least one post-baseline assessment or a reported treatment emergent adverse event. This population was analyzed based upon the actual treatment received.
 
Arm/Group Title Serlopitant 5 mg Placebo
Hide Arm/Group Description Subjects received a 3-tablet oral loading dose (15 mg) on the first day of the treatment period followed by a 5 mg dose of Serlopitant taken once daily by mouth for 8 weeks Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a Placebo tablet taken once daily by mouth for 8 weeks
All-Cause Mortality
Serlopitant 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/102 (0.00%)      1/100 (1.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Serlopitant 5 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/102 (0.00%)      2/100 (2.00%)    
Injury, poisoning and procedural complications     
Overdose   0/102 (0.00%)  0 1/100 (1.00%)  1
Road traffic accident   0/102 (0.00%)  0 1/100 (1.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Serlopitant 5 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/102 (8.82%)      17/100 (17.00%)    
Gastrointestinal disorders     
Diarrhoea   3/102 (2.94%)  3 3/100 (3.00%)  4
Infections and infestations     
Nasopharyngitis   2/102 (1.96%)  2 6/100 (6.00%)  6
Upper Respiratory Tract Infection   1/102 (0.98%)  1 4/100 (4.00%)  4
Nervous system disorders     
Headache   3/102 (2.94%)  3 5/100 (5.00%)  7
Indicates events were collected by 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: Paul Kwon
Organization: Chief Scientific Officer
Phone: 650-486-1416
EMail: pkwon@menlotx.com
Layout table for additonal information
Responsible Party: Menlo Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03343639     History of Changes
Other Study ID Numbers: MTI-109
First Submitted: November 10, 2017
First Posted: November 17, 2017
Results First Submitted: May 23, 2019
Results First Posted: June 12, 2019
Last Update Posted: June 27, 2019