Incyte announces 24-week long-term data from Phase 3 TRuE-AD4 trial

Incyte (INCY) announced final 24-week data from the Phase 3 TRuE-AD4 study evaluating the efficacy and safety of Opzelura cream in adults with moderate atopic dermatitis who had an inadequate response, intolerance or contraindication to topical corticosteroids and topical calcineurin inhibitors. These data were presented at the 2026 European Academy of Dermatology and Venereology Symposium. 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 and, separately, IGA-TS. Patients who achieved an EASI50 response at Week 8 continued double-blind treatment, as needed, through Week 24. Most patients 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. Mean affected body surface area remained low and itch relief remained high with Opzelura treatment. As-needed treatment with Opzelura was well tolerated, with few application site reactions and no new safety signals up to 24 weeks. The most common treatment-emergent adverse events were upper respiratory tract infection and nasopharyngitis. “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,” said Pablo Cagnoni, President and Global Head of Research and Development, Incyte. “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.”