Opzelura Showed Sustained 24-Week Disease Control in Phase 3 TRuE-AD4 Trial in Adults With Moderate Atopic Dermatitis – Incyte

Incyte announced final 24-week data from the Phase 3 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 were presented (Abstract ID: P0851) today at the 2026 European Academy of Dermatology and Venereology (EADV) Symposium, being held May 7–9, 2026, in Athens, Greece.

As previously reported, the TRuE-AD4 study met both of its co-primary endpoints at Week 8, with a statistically significantly higher proportion of patients on Opzelura versus vehicle cream achieving EASI75 (≥75% improvement in Eczema Area and Severity Index score from baseline) and, separately, IGA-TS (Investigator’s Global Assessment Treatment Success, defined as an IGA score of 0 [clear] or 1 [almost clear] with at least a two-point improvement from baseline).

Patients who achieved an EASI50 response at Week 8 continued double-blind treatment, as needed, through Week 24. Most patients (84.3%) in the Opzelura treatment group completed treatment through Week 24. Among those patients, 84.3% achieved EASI75 and 70.6% achieved IGA-TS at Week 24, similar to the frequencies at Week 8 (83.5% and 74.4%, respectively). Mean affected body surface area (BSA) remained low (2.5% at Weeks 8 and 24) and itch relief (NRS4; ≥4-point improvement in Itch Numeric Rating Scale) remained high (74.3% at Week 8 and 64.7% at Week 24) with Opzelura treatment.

As-needed treatment with Opzelura was well tolerated, with few application site reactions (1.7%) and no new safety signals up to 24 weeks. The most common treatment-emergent adverse events were upper respiratory tract infection (10.6%) and nasopharyngitis (6.3%).

“We are pleased to share these results, which demonstrate sustained disease control over 24 weeks in adults with moderate AD and further reinforce the well-tolerated safety profile of Opzelura. We look forward to continuing to work with EU regulatory authorities to bring this differentiated, nonsteroidal treatment option to European adults with moderate AD who have progressed on standard topical therapies.” – Pablo J. Cagnoni, M.D., President and Global Head of Research and Development, Incyte.

More information regarding the EADV Symposium can be found at: https://eadv.org/symposium/.