Incyte presented final 24-week Phase 3 TRuE-AD4 data showing sustained efficacy and a favorable safety profile for Opzelura® (ruxolitinib) cream in adults with moderate atopic dermatitis who had inadequate response or intolerance to standard topical therapies.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
Incyte has presented final 24-week data from the Phase 3 TRuE-AD4 study showing sustained efficacy and a consistent safety profile for Opzelura® (ruxolitinib) cream in adults with moderate atopic dermatitis (AD). The data were presented at the 2026 European Academy of Dermatology and Venereology (EADV) Symposium in Athens, Greece.
TRuE-AD4 (NCT06238817) evaluated Opzelura in adults with moderate AD who had an inadequate response, intolerance, or contraindication to topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs). The study had previously met both co-primary endpoints at Week 8, demonstrating significantly higher rates of EASI75 and Investigator’s Global Assessment Treatment Success (IGA-TS) versus vehicle cream.
Among patients in the Opzelura group who completed treatment through Week 24, 84.3% achieved EASI75 and 70.6% achieved IGA-TS, indicating durable disease control. Patients also maintained low affected body surface area, averaging 2.5% at both Week 8 and Week 24, and 64.7% achieved at least a four-point improvement in Itch Numeric Rating Scale (NRS4) at Week 24.
Opzelura continued to show a favorable tolerability profile through 24 weeks of as-needed treatment. Application-site reactions occurred in 1.7% of patients, and no new safety signals were identified. The most common treatment-emergent adverse events were upper respiratory tract infection (10.6%) and nasopharyngitis (6.3%).
Pablo J. Cagnoni, M.D., President and Global Head of Research and Development at Incyte, said the results support sustained disease control and reinforce the treatment’s well-tolerated safety profile. Incyte said the findings will support ongoing discussions with European regulators and a planned Type-II variation application for adults with moderate AD in Europe.
Opzelura® (ruxolitinib) cream is a topical JAK1/JAK2 inhibitor approved in the United States for nonsegmental vitiligo in patients aged 12 years and older and for short-term, non-continuous treatment of mild-to-moderate atopic dermatitis in eligible patients aged 2 years and older. In Europe, Opzelura 15 mg/g cream is approved for nonsegmental vitiligo with facial involvement in adults and adolescents aged 12 years and older.
Atopic dermatitis (AD), the most common form of eczema, is a chronic inflammatory skin disease characterized by intense itching, irritated skin, and recurrent lesions, affecting up to 25% of children and 12% of adults worldwide.
TRuE-AD4 enrolled 241 adult patients with moderate AD involving 10% to 20% body surface area and randomized them 2:1 to receive Opzelura or vehicle cream twice daily.
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About the Writer
Fariha Sameen, PharmD (Linkedin) is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.