Phase III TRuE-AD3 study of Opzelura meets primary endpoint in atopic dermatitis – Incyte

Incyte announced positive topline results from its randomized, vehicle-controlled, pivotal Phase III TRuE-AD3 study evaluating the safety and efficacy of Opzelura (ruxolitinib cream) in children (age at least 2 to <12 years) with atopic dermatitis (AD).

The study met its primary endpoint and showed significantly more patients treated with ruxolitinib cream 0.75% and 1.5% achieved Investigator’s Global Assessment Treatment Success (IGA-TS) than patients treated with vehicle control (non-medicated cream). Investigator’s Global Assessment Treatment Success (IGA-TS) is defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline at Week 8.

The overall safety profile of ruxolitinib cream is consistent with previous data, and no new safety signals were observed. The long-term safety portion of the study will continue as planned. Data from TRuE-AD3 will be submitted for presentation at an upcoming scientific meeting.