Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
Summary
The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants with Hidradenitis Suppurativa. This is a randomized 16-week double-blind, vehicle-controlled (DBVC) study followed by a 16 week open label extension period (OLE) with an active treatment for participants who complete the DBVC period.
Timeline
- Start
- 2022-12-07
- Primary completion
- 2023-10-19
- Completion
- 2024-03-14
Outcome
Met primary endpoint
registry analysis (superiority test); Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID vs DBVC Period: Vehicle Cream BID; p = 0.0215; least squares mean difference -1.20 (95% CI -2.21 to -0.18); ANCOVA NCT05635838 ↗
release “Randomized Phase 2 study met the primary endpoint in patents with hidradenitis suppurativa (HS), reinforcing efficacy and safety profile of ruxolitinib cream” incyte.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ruxolitinib | Small molecule | 1.5 % | Topical |