Press release
Incyte Announces New Data from Phase 3b TRuE-AD4 Trial of Opzelura® (Ruxolitinib Cream) in Adults with Moderate Atopic Dermatitis
Eight-week results from the TRuE-AD4 trial demonstrate treatment with Opzelura® (ruxolitinib cream) significantly improved the clinical signs of atopic
About this update from Incyte Corporation
[{"type":"text","content":"\n\nEight-week results from the TRuE-AD4 trial demonstrate treatment with Opzelura® (ruxolitinib cream) significantly improved the clinical signs of atopic dermatitis (AD), including improved itch as early as Day 2, and was well tolerated in adults with moderate AD who had an inadequate response, intolerance or contraindication to topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs)\n\n\n\n\n\nAt Week 8, 70% of patients treated with Opzelura achieved a ≥75% improvement in the Eczema Area and Severity Index (EASI75) and 61.3% achieved Investigator’s Global Assessment Treatment Success (IGA-TS), co-primary endpoints of the study\n\n\n\n\n\nBased on these results, Incyte expects to file a Type-II variation application for ruxolitinib cream 1.5% for the treatment of adults with moderate AD in the European Union (EU) by end of year\n\n\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced new data from the Phase 3b TRuE-AD4 study evaluating the efficacy and safety of Opzelura® (ruxolitinib cream) in adults with moderate atopic dermatitis (AD) who had an inadequate response, intolerance or contraindication to topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs). These data will be presented during the Systemic and New Therapies for Atopic Dermatitis session on Sunday, October 26 at 10:55 a.m. AEDT (Saturday, October 25 at 7:55 p.m. ET) (Abstract #1177) at the 15th Georg Rajka International Symposium on Atopic Dermatitis (ISAD), held from October 24 – 26, 2025, in Melbourne.\n\n\nData from TRuE-AD4, which build on previously announced topline results, show the study met its co-primary endpoints at Week 8, with a statistically significant proportion of patients achieving both a ≥75% improvement in Eczema Area and Severity Index (EASI75) score from baseline (70.0% with Opzelura vs. 18.5% with vehicle, P","length":2347,"tagName":"div"}]