A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis
Summary
This study is being conducted to establish the efficacy of ruxolitinib cream in participants with moderate AD who had an inadequate response to, or are intolerant to, or contraindicated to topical corticosteroid (TCS)s and topical calcineurin inhibitor (TCI)s.
Timeline
- Start
- 2024-04-26
- Primary completion
- 2025-05-21
- Completion
- 2025-10-17
Outcome
Met primary endpoint
registry analysis (superiority test); Vehicle Cream vs Ruxolitinib 1.5% Cream; p <0.0001; Odds Ratio (OR) 11.26 (95% CI 5.692 to 22.260); Cochran-Mantel-Haenszel NCT06238817 ↗
registry analysis (superiority test); Vehicle Cream vs Ruxolitinib 1.5% Cream; p <0.0001; Odds Ratio (OR) 10.14 (95% CI 4.904 to 20.975); Cochran-Mantel-Haenszel NCT06238817 ↗
release “Data from TRuE-AD4, which build on previously announced topline results, show the study met its co-primary endpoints at Week 8” incyte.com ↗
release “the TRuE-AD4 study met both of its co-primary endpoints at Week 8” incyte.com ↗
release “In the TRuE‑AD4 study the co‑primary endpoints were met at Week 8” incyte.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ruxolitinib | Small molecule | 1.5 % | Topical |