Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03540160 · ClinicalTrials.gov registry record · Phase 3
Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)
A Phase 3 study, sponsored by Vyne Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 558
- Enrollment target
NCT03540160: Clinical Trial Phase 3 study, sponsored by Vyne Therapeutics.
NCT03540160 is a Phase 3 study that was terminated before completion, run by Vyne Therapeutics. The registered enrollment target is 558 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03540160, a Phase 3 study, was terminated before completion, sponsored by Vyne Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 558 participants
- Enrollment target
Study Summary
Study of the long term safety of serlopitant for the treatment of pruritus in adults.
Primary Outcome
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.
Interventions
- DRUG 5 mg Serlopitant Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 558 participants |
| Start Date | 2018-03-15 |
| Est. Completion | 2020-06-17 |
| Phase | Phase 3 |
Why NCT03540160 stopped before completion
NCT03540160 is an interventional study that assigns participants to a tested intervention. The registered 558 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 (28% lower).
The record links to 0 conditions, and to 1 intervention - of which 5 mg Serlopitant Tablets is the first listed.
NCT03540160 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03540160 about?
NCT03540160 is a clinical study titled "Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)". Study of the long term safety of serlopitant for the treatment of pruritus in adults.
What is the current status of trial NCT03540160?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 558 participants. The study started on 2018-03-15. Estimated completion is 2020-06-17.
What interventions are being tested in trial NCT03540160?
The interventions under investigation include: 5 mg Serlopitant Tablets (DRUG).
Who is sponsoring clinical trial NCT03540160?
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 NCT03540160's enrollment target sits among peer trials
558 673rd of 2000 higher than 1,327 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07173751 · 558 participants · Phase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
- NCT05708885 · 557 participants · NA
Striated Esophageal Motor Function Modulation in Health and Disease
- NCT04661358 · 560 participants · Phase 3
Fenofibrate for Prevention of DR Worsening
- NCT05473871 · 560 participants · NA
Enhancing Capacity in Churches to Implement PA Programs
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI