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NCT03546816 · ClinicalTrials.gov registry record · Phase 3
Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis
A Phase 3 study, sponsored by Vyne Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 285
- Enrollment target
NCT03546816: Completed Phase 3 study, sponsored by Vyne Therapeutics.
NCT03546816 is a Phase 3 study that has completed, run by Vyne Therapeutics. The registered enrollment target is 285 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03546816, a Phase 3 study, has completed, sponsored by Vyne Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 285 participants
- Enrollment target
Study Summary
Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with prurigo nodularis
Primary Outcome
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 t
Interventions
- DRUG Placebo Tablets
- DRUG 5mg Serlopitant Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 285 participants |
| Start Date | 2018-05-02 |
| Est. Completion | 2020-02-14 |
| Phase | Phase 3 |
What the finished NCT03546816 record still lists
NCT03546816 is an interventional study that assigns participants to a tested intervention. The registered 285 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Tablets is the first listed.
NCT03546816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03546816 about?
NCT03546816 is a clinical study titled "Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis". Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with prurigo nodularis
What is the current status of trial NCT03546816?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 285 participants. The study started on 2018-05-02. Estimated completion is 2020-02-14.
What interventions are being tested in trial NCT03546816?
The interventions under investigation include: Placebo Tablets (DRUG), 5mg Serlopitant Tablets (DRUG).
Who is sponsoring clinical trial NCT03546816?
This trial is sponsored by Vyne Therapeutics, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03546816's enrollment target sits among peer trials
285 1185th of 2000 higher than 812 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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