A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus in Adults With Prurigo Nodularis

Last updated: N/A
Sponsor: N/A
Overall Status: Active - Recruiting

Phase

3

Condition

Prurigo Nodularis

Treatment

N/A

Clinical Study ID

TX205367
  • Ages 18-100
  • All Genders

Study Summary

This is a double-blind, randomized, placebo-controlled study to assess the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus (itching) in adults with prurigo nodularis (abbreviated as PN, a skin condition with multiple very itchy, solid skin bumps that develop due to scratching).

All enrolled subjects will receive oral medication to be taken daily for 8 weeks. There are 9 in-office visits throughout the study and can include a physical exam, blood draws, urine sampling, assessments by qualified professionals and other assessments which will be reviewed in detail at your screening visit. All services are provided at no cost.

Eligibility Criteria

Inclusion

Eligible male and female participants will be 18 years of age or older, have a diagnosis of PN with 10+ nodules on 2 different body parts. Female subjects cannot plan to be pregnant or breast feeding during the study. Subjects must be available for the 9 office visits during the study and be willing to comply with all study instructions. Several other restrictions and criteria may apply that the study doctor will review with you to determine if you qualify to enter the study.

Study Design

Study Start date:
Estimated Completion Date:

Study Description

- Physical exam and assessments of study condition to be provided at no cost by an experienced provider. - No insurance necessary. - Compensation will be provided for time and travel for all completed study visits. - Stipend range: up to $540.00.