drugset / Trial / NCT03841331

Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin

NCT03841331 ↗

Phase 2 Completed 233 enrolled Vyne Therapeutics Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin

Timeline

Start
2019-01-22
Primary completion
2019-12-10
Completion
2020-01-21

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Serlopitant 5 mg; p = 0.5861; Treatment Effect -1.4 (95% CI -13.9 to 11.1) NCT03841331 ↗

registry analysis (superiority test); Placebo vs Serlopitant 5 mg; p = 0.2440; Mean Difference (Final Values) 2.44 (95% CI -4.98 to 9.87) NCT03841331 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Serlopitant Small molecule 5 mg —

Indications

No indication recorded.