Incyte has announced results from the Phase IIIb TRuE-AD4 trial of Opzelura (ruxolitinib cream) for adults with moderate atopic dermatitis (AD) who had contraindications, inadequate response or intolerance to topical corticosteroids and calcineurin inhibitors.
The double-blind, randomised, vehicle-controlled study is designed to assess the safety and efficacy of Opzelura and enrolled 241 patients aged 18 years and above.
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Study data showed that the trial achieved its co-primary endpoints at week eight.
Statistically, 70% of participants on Opzelura attained at least 75% improvement in the Eczema Area and Severity Index (EASI75) compared to 18.5% in the vehicle group.
In this trial, 61.3% subjects achieved Investigator’s Global Assessment Treatment Success (IGA-TS), ahead of 13.6% for the vehicle.
Incyte Inflammation and Autoimmunity Group vice-president Jim Lee said: “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.
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By GlobalData“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.”
Nearly 62.5% of Opzelura participants achieved a four-point improvement in itch by week eight versus 19.8% on vehicle.
Significant itch reduction occurred as soon as day two, and a moderate effect was documented 15 minutes after application.
Additional endpoints included improved Patient-Oriented Eczema Measure (POEM) and Dermatology Life Quality Index (DLQI) scores.
Near-clear status was achieved by 39.7% of Opzelura recipients by week eight, and a mean DLQI score improvement was observed from 19.3 to 4.3 versus 19.1 to 10.7 for vehicle.
Opzelura was found to be well tolerated, with no major adverse cardiovascular events (MACE), serious infection, thromboses, or malignancies reported. The most frequent adverse event was application site acne.
