Trial Outcomes & Findings for Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Plaque Psoriasis (NCT NCT03343639)
NCT ID: NCT03343639
Last Updated: 2021-05-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
204 participants
Primary outcome timeframe
8 weeks
Results posted on
2021-05-20
Participant Flow
Participant milestones
| Measure |
Serlopitant 5 mg
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
|
Placebo
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 Study
STARTED
|
102
|
102
|
|
Overall Study
COMPLETED
|
88
|
90
|
|
Overall Study
NOT COMPLETED
|
14
|
12
|
Reasons for withdrawal
| Measure |
Serlopitant 5 mg
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
|
Placebo
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 Study
Withdrawal by Subject
|
10
|
6
|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Serlopitant 5 mg
n=102 Participants
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
|
Placebo
n=101 Participants
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
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.2 years
STANDARD_DEVIATION 15.2 • n=99 Participants
|
46.7 years
STANDARD_DEVIATION 12.34 • n=107 Participants
|
47.5 years
STANDARD_DEVIATION 13.84 • n=206 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
84 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
173 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=99 Participants
|
101 participants
n=107 Participants
|
203 participants
n=206 Participants
|
|
WI-NRS
|
8.303 units on a scale
STANDARD_DEVIATION 1.0277 • n=99 Participants
|
8.082 units on a scale
STANDARD_DEVIATION 1.0588 • n=107 Participants
|
8.193 units on a scale
STANDARD_DEVIATION 1.0466 • n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: These figures represent full analysis set.
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.
Outcome measures
| Measure |
Serlopitant 5 mg
n=102 Participants
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
|
Placebo
n=101 Participants
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
|
|---|---|---|
|
WI-NRS 4-point Responder Rate at Week 8
|
33.29 % of subjects (incl. imputed data)
|
21.07 % of subjects (incl. imputed data)
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: These figures represent full analysis set
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.
Outcome measures
| Measure |
Serlopitant 5 mg
n=102 Participants
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
|
Placebo
n=101 Participants
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
|
|---|---|---|
|
WI-NRS 4-point Responder Rate at Week 4
|
20.78 percentage of subjects
|
11.49 percentage of subjects
|
SECONDARY outcome
Timeframe: Change from baseline to day 7Population: These figures represent full analysis set
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.
Outcome measures
| Measure |
Serlopitant 5 mg
n=102 Participants
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
|
Placebo
n=101 Participants
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
|
|---|---|---|
|
Change in WI-NRS From Baseline to Day 7
|
-1.307 units on a scale
Standard Deviation 1.8741
|
-0.785 units on a scale
Standard Deviation 1.8391
|
SECONDARY outcome
Timeframe: 3 daysPopulation: These figures represent full analysis set.
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.
Outcome measures
| Measure |
Serlopitant 5 mg
n=102 Participants
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
|
Placebo
n=101 Participants
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
|
|---|---|---|
|
Change in WI-NRS From Baseline to Day 3
|
-0.702 units on a scale
Standard Deviation 1.4111
|
-0.461 units on a scale
Standard Deviation 1.4060
|
Adverse Events
Serlopitant 5 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Serlopitant 5 mg
n=102 participants at risk
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
|
Placebo
n=100 participants at risk
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
|
|---|---|---|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/102 • 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.
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.
|
1.0%
1/100 • Number of events 1 • 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.
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.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/102 • 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.
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.
|
1.0%
1/100 • Number of events 1 • 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.
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.
|
Other adverse events
| Measure |
Serlopitant 5 mg
n=102 participants at risk
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
|
Placebo
n=100 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
3/102 • Number of events 3 • 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.
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.
|
3.0%
3/100 • Number of events 4 • 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.
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.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
2/102 • Number of events 2 • 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.
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.
|
6.0%
6/100 • Number of events 6 • 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.
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.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.98%
1/102 • Number of events 1 • 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.
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.
|
4.0%
4/100 • Number of events 4 • 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.
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.
|
|
Nervous system disorders
Headache
|
2.9%
3/102 • Number of events 3 • 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.
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.
|
5.0%
5/100 • Number of events 7 • 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.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place