MedTrace Logo

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

NCT03836001 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-02-14

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Epidermolysis Bullosa

Interventions

DRUG

Serlopitant Tablet

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.

DRUG

Placebo Oral Tablet

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

Sponsors & Collaborators

  • Epidermolysis Bullosa Research Partnership

    collaborator OTHER_GOV

  • Vyne Therapeutics Inc.

    collaborator INDUSTRY

  • Stanford University

    lead OTHER

Principal Investigators

  • Albert S Chiou, MD/MBA · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-18
Primary Completion
2021-12-06
Completion
2022-06-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03836001 on ClinicalTrials.gov