WILMINGTON, DE — Incyte (Nasdaq: INCY) recently reported 24-week Phase 3 trial results showing sustained disease control for adults with moderate atopic dermatitis treated with Opzelura cream, as the company seeks expanded regulatory approval for the therapy in Europe.
The data, presented at the 2026 European Academy of Dermatology and Venereology Symposium in Athens, evaluated Opzelura, or ruxolitinib cream, in patients whose eczema had not responded adequately to standard topical corticosteroids or calcineurin inhibitors.
The results support Incyte’s Type-II variation application in the European Union seeking approval of ruxolitinib cream 1.5% for adults with moderate atopic dermatitis. The company expects regulatory feedback during the first half of 2026.
Patients who achieved at least a 50% improvement in Eczema Area and Severity Index scores at Week 8 continued double-blind treatment through Week 24 on an as-needed basis.
Among patients continuing treatment through Week 24, 84.3% achieved at least a 75% improvement in Eczema Area and Severity Index scores, while 70.6% achieved Investigator’s Global Assessment Treatment Success.
Incyte reported that affected body surface area remained low through Week 24 and itch relief levels remained elevated throughout the treatment period.
The company also reported low rates of application-site reactions and no new safety concerns during the 24-week period.
Upper respiratory tract infections and nasopharyngitis were the most commonly reported adverse events.
“We are pleased to share these results, which demonstrate sustained disease control over 24 weeks in adults with moderate AD,” Pablo J. Cagnoni, president and global head of research and development at Incyte, said.
The Phase 3 TRuE-AD4 study previously met its co-primary endpoints at Week 8, with statistically significant improvements compared with vehicle cream across both disease severity and treatment success measures.
Opzelura is a nonsteroidal topical Janus kinase inhibitor approved in several markets for inflammatory skin conditions including atopic dermatitis.
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