CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Serlopitant Tablet +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03836001
NCT03836001Phase 2Completed
CompareCT.gov

A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa

Stanford University·interventional·Posted Feb 11, 2019·Updated Feb 14, 2023

In Brief

A Phase 2 clinical trial evaluating Serlopitant Tablet and Placebo Oral Tablet for Epidermolysis Bullosa. Completed, enrolled 28 participants across 1 site.

Detailed Summary

To determine if Serlopitant (when taken by mouth) is safe and works on itch in patients aged 13 and above with EB.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpidermolysis Bullosa
CountriesUnited States
CollaboratorsEpidermolysis Bullosa Research Partnership, Vyne Therapeutics Inc.

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedFeb 11, 2019
Enrollment StartApr 18, 2019
Primary CompletionDec 6, 2021
Study CompletionJun 24, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.4 years ago

Interventions

Serlopitant Tabletdrug

Serlopitant is a small molecule, highly selective NK1-R (neurokinin-1 receptor) antagonist. Two critical mediators of the urge to scratch are Substance P, or SP, and its receptor, NK1-R. SP is a naturally occurring peptide in the tachykinin neuropeptide family. Tachykinins have a broad range of functions in the nervous and immune systems. SP binding of NK1-R has been shown to be a key mediator of sensory nerve signaling, including the itch-scratch reflex and the vomiting reflex.

Placebo Oral Tabletdrug

The placebo is a tablet that looks like a drug but has no drug or other active ingredient in it.