Incyte has reported final 24-week data from the Phase III TRuE-AD4 study.

The results show sustained efficacy along with a consistent safety profile for Opzelura (ruxolitinib) cream in adults with moderate atopic dermatitis who were unable to adequately manage disease with topical corticosteroids or topical calcineurin inhibitors.

The data, presented at the 2026 European Academy of Dermatology and Venereology Symposium in Athens, build on previously reported Week 8 results in which the study met both co-primary endpoints. Opzelura demonstrated statistically significant improvements versus vehicle cream in EASI75 and Investigator’s Global Assessment Treatment Success.¹

What is Atopic Dermatitis?

Atopic Dermatitis, the most common type of eczema, is a chronic, recurring, inflammatory and highly pruritic skin condition that affects up to 25% of children and up to 12% of adults worldwide, with signs and symptoms including irritated and itchy skin that can cause red lesions that may ooze and crust.¹

What is Opzelura cream?

Opzelura cream is a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib. The treatment is currently approved in the United States for mild-to-moderate atopic dermatitis in non-immunocompromised patients aged two years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.¹ The therapy is also approved in the U.S. and Europe for certain patients with nonsegmental vitiligo.

What were the results at Week 24?

The TRuE-AD4 trial enrolled adults with moderate atopic dermatitis affecting 10% to 20% of body surface area who had an inadequate response, intolerance, or contraindication to standard topical therapies. Patients achieving at least a 50% improvement in Eczema Area and Severity Index scores at Week 8 continued treatment through Week 24 on an as-needed basis.²

Among patients treated with Opzelura who completed treatment through Week 24, 84.3% achieved EASI75, while 70.6% achieved Investigator’s Global Assessment Treatment Success.¹ Disease control remained stable over the treatment period, with mean affected body surface area remaining at 2.5% at both Week 8 and Week 24.¹ Itch relief also remained durable, with 64.7% of patients maintaining at least a four-point improvement on the Itch Numeric Rating Scale at Week 24.

“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 J. Cagnoni, MD, president and global head of research and development at 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.”

The safety profile remained consistent with prior findings, as few application site reactions were reported.¹ The most common treatment-emergent adverse events were upper respiratory tract infection and nasopharyngitis, and no new safety signals were identified through 24 weeks.

Why is the data important?

The data adds to growing evidence supporting the use of nonsteroidal topical therapies in atopic dermatitis, particularly for patients seeking alternatives to long-term corticosteroid use. As the atopic dermatitis treatment landscape continues to evolve, topical Janus kinase inhibitors such as Opzelura are increasingly being evaluated for their ability to provide durable symptom control while minimizing systemic exposure.

Last year when Incyte announced results from the Phase IIIb TRuE-AD4 trial, Jim Lee, M.D., group vice president, Inflammation & Autoimmunity, Incyte touched on the importance of ther trial findings, saying: “The TRuE-AD4 data further reinforces the safety and efficacy profile of Opzelura and its ability to control key signs and symptoms of moderate AD, including improvement in bothersome symptoms like itch.”

Lee continued, saying: “These data will support the filing of a Type-II variation application for ruxolitinib cream 1.5% (Opzelura) in Europe, as we seek to meet the needs of more patients around the world who require nonsteroidal topical treatments for moderate AD.”

Sources

1. Incyte Announces 24-Week Long-Term Data from Phase 3 TRuE-AD4 Trial of Opzelura® (ruxolitinib) Cream in Adults with Moderate Atopic Dermatitis Incyte May 7, 2026 https://www.businesswire.com/news/home/20260507606978/en/Incyte-Announces-24-Week-Long-Term-Data-from-Phase-3-TRuE-AD4-Trial-of-Opzelura-ruxolitinib-Cream-in-Adults-with-Moderate-Atopic-Dermatitis
2. A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis (TRuE-AD4) National Library of Medicine October 28, 2025 https://clinicaltrials.gov/study/NCT06238817
3. Incyte Announces New Data from Phase 3b TRuE-AD4 Trial of Opzelura® (Ruxolitinib Cream) in Adults with Moderate Atopic Dermatitis Incyte October 25, 2025 https://investor.incyte.com/news-releases/news-release-details/incyte-announces-new-data-phase-3b-true-ad4-trial-opzelurar