Incyte Presents Phase 3b TRuE-AD4 Trial Results of Opzelura® (Ruxolitinib Cream) for Moderate Atopic Dermatitis in Adults

10/25/2025 – 07:55 PM

Incyte (Nasdaq:INCY) has released compelling new data from its Phase 3b TRuE-AD4 trial, showcasing the efficacy and safety of Opzelura^® (ruxolitinib cream) in adult patients grappling with moderate atopic dermatitis (AD). The study focused on individuals who experienced inadequate responses, intolerance, or contraindications to topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs). The findings, presented at the 15th Georg Rajka International Symposium on Atopic Dermatitis (ISAD) in Melbourne, Australia, are poised to influence treatment strategies for this prevalent skin condition.

The TRuE-AD4 trial’s eight-week results demonstrated notable improvements in AD clinical signs. Specifically, patients treated with Opzelura exhibited significant itch reduction as early as Day 2, alongside a favorable tolerability profile. At Week 8, a substantial 70% of patients achieved a ≥75% improvement in the Eczema Area and Severity Index (EASI75), a key metric for assessing AD severity, compared to the vehicle group. Furthermore, 61.3% of patients achieved Investigator’s Global Assessment Treatment Success (IGA-TS), another co-primary endpoint, indicating the cream’s effectiveness in achieving clear or almost clear skin with at least a two-point improvement from baseline.

• Eight-week results from the TRuE-AD4 trial demonstrate treatment with Opzelura^® (ruxolitinib cream) significantly improved the clinical signs of atopic dermatitis (AD), including improved itch as early as Day 2, and was well tolerated in adults with moderate AD who had an inadequate response, intolerance or contraindication to topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs)
  
• At Week 8, 70% of patients treated with Opzelura achieved a ≥75% improvement in the Eczema Area and Severity Index (EASI75) and 61.3% achieved Investigator’s Global Assessment Treatment Success (IGA-TS), co-primary endpoints of the study
  

These results are particularly significant given the limitations of existing topical treatments for many AD patients. TCSs, while effective, can have long-term side effects with prolonged use, and TCIs are not suitable for all patients. Opzelura represents a non-steroidal alternative, targeting the JAK-STAT signaling pathway, which plays a critical role in the inflammation and itch associated with AD. The cream selectively inhibits JAK1 and JAK2, potentially offering a more targeted approach compared to broader immunosuppressants.

“The TRuE-AD4 data further reinforce 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,” said Jim Lee, M.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “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.”

Based on these findings, Incyte plans to file a Type-II variation application for ruxolitinib cream 1.5% for the treatment of adults with moderate AD in the European Union (EU) by the end of the year. This regulatory submission could pave the way for broader access to Opzelura for European patients seeking alternatives to traditional topical treatments.

• Based on these results, Incyte expects to file a Type-II variation application for ruxolitinib cream 1.5% for the treatment of adults with moderate AD in the European Union (EU) by end of year

Further analysis of the TRuE-AD4 data revealed additional benefits:

• Rapid Itch Relief: A clinically meaningful ≥4-point improvement in Itch Numeric Rating Scale (NRS4) score was achieved by nearly two-thirds (62.5%) of Opzelura-treated patients by Week 8, versus 19.8% in the vehicle group (P<0.0001). Notably, significant improvement in worst daily itch was observed as early as Day 2, with 29.1% of patients in the Opzelura arm achieving Itch NRS4 compared to 14.3% with vehicle (P=0.0072). This rapid onset of action is crucial for patients seeking immediate relief from the debilitating itch associated with AD.
  • Nearly two-thirds (62.5%) of patients treated with Opzelura achieved Itch NRS4 by Week 8 (vs. 19.8% with vehicle, P
  • There was significant improvement in worst daily itch at Day 2 with 29.1% of patients treated with Opzelura achieving Itch NRS4 vs. 14.3% with vehicle (P=0.0072; by multiple imputation).

  • Current Itch NRS4 was also measured at 15 minutes (16.4% with Opzelura vs. 7.7% with vehicle).

• Improved Quality of Life: Patient-reported outcomes, as measured by the Patient-Oriented Eczema Measure (POEM) and Dermatology Life Quality Index (DLQI) scores, also showed significant improvements. A greater proportion of patients treated with Opzelura achieved a POEM score of 0–2 (clear or almost clear) at Week 8 (39.7% vs. 8.6% with vehicle). Furthermore, patients treated with Opzelura demonstrated a substantial mean DLQI score improvement at Week 8 (from 19.3 to 4.3 with Opzelura vs. 19.1 to 10.7 with vehicle), highlighting the positive impact on patients’ daily lives.
  • More patients treated with Opzelura vs. vehicle achieved a POEM score 0–2 (clear or almost clear) at Week 8 (39.7% vs. 8.6%).

  • Patients treated with Opzelura showed a mean DLQI score improvement at Week 8 (from 19.3 to 4.3 with Opzelura vs. 19.1 to 10.7 with vehicle).

From a safety perspective, Opzelura was well-tolerated throughout the study. “AD is a challenging, chronic condition and I believe that these data reinforce Opzelura as an important therapeutic option.” said Dr. Andreas Wollenberg, Professor of Dermatology and Allergy, Augsburg University Hospital, Germany. No serious infections, major adverse cardiovascular events (MACE), malignancies, or thromboses were reported during the eight-week vehicle-controlled period. The most common treatment-related adverse event observed in the Opzelura arm was application site acne (4.4% vs 0% in the vehicle arm), which is generally considered manageable.

The market for AD treatments is substantial, driven by the high prevalence of the condition and the unmet needs of many patients. Analysts are closely watching Incyte’s progress with Opzelura, as its potential to offer a safe and effective non-steroidal alternative could significantly impact the competitive landscape. The upcoming regulatory decision in Europe will be a key milestone for the company and for AD patients seeking innovative treatment options.