drugset / Trial / NCT05764161
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ruxolitinib | Small molecule | 1.5 % | Topical |