drugset / Trial / NCT05764161

A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

NCT05764161 ↗

Phase 3 Completed 190 enrolled Incyte Corporation
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).

Timeline

Start
2023-06-12
Primary completion
2024-12-30
Completion
2025-11-04

Outcome

Missed primary endpoint

registry analysis (superiority test); Vehicle Cream BID to Ruxolitinib 1.5% Cream BID vs Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID; p = 0.5859 NCT05764161 ↗

release “Topline data from a separate Phase 3 study, TRuE-PN2, showed that while the primary endpoint did not reach statistical significance” incyte.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ruxolitinib Small molecule 1.5 % Topical

Indications