Incyte Announces 24-Week Data For Opzelura Cream In Adults With Moderate Atopic Dermatitis

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) 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%).

Data support Type-II variation application submitted for ruxolitinib cream 1.5% for the treatment of adults with moderate AD in the European Union (EU), feedback expected in First Half 2026. TRuE-AD4 (NCT06238817) is a randomized, double-blind, vehicle-controlled Phase 3b study designed to evaluate the efficacy and safety of Opzelura (ruxolitinib) cream in adults with moderate atopic dermatitis (AD). The study enrolled 241 patients (=18 years old) who met the specific inclusion criteria, including an IGA (Investigator's Global Assessment) score of 3 and an EASI (Eczema Area and Severity Index) score greater than 7 at both screening and Day 1, and who have AD on 10% to 20% of their Body Surface Area (BSA; excluding scalp).

Patients also had to have a documented history of inadequate response, intolerance or contraindication to topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) within the 12 months prior to the screening visit. Patients were randomized 2:1 to receive Opzelura applied twice daily (BID) or vehicle (non-medicated cream) BID. At Week 8, patients who achieved EASI50 continued double-blind, BID treatment, applied as needed for an additional 16 weeks.

Patients for whom EASI50 was not achieved at two consecutive visits =1 week apart were eligible to enter the escape arm at Week 8 or later, in which open-label Opzelura cream was applied as needed. The co-primary endpoints of TRuE-AD4 were the proportion of patients achieving IGA Treatment Success (IGA-TS), defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline, and EASI75, defined as =75% improvement in EASI score, at Week 8. Secondary endpoints included the proportion of patients with a =4-point improvement in NRS4 (=4-point improvement in Itch Numeric Rating Scale) score at various time points. Other efficacy measures included the proportion of patients who achieved IGA-TS, NRS4, EASI75, a negative change from baseline in the affected body surface area (%BSA), change from baseline in the skin pain NRS score, EASI50 and more, measured at various time points.

The study also tracked the frequency, duration and severity of adverse events associated with the use of Opzelura. Opzelura (ruxolitinib) cream, a novel cream formulation of Incyte?s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. FDA for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of nonsegmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Incyte has worldwide rights for the development and commercialization of Opzelura.