TRuE-AD2 pivotal trial of ruxolitinib cream met its primary endpoint in patients with atopic dermatitis.- Incyte Corpn.

Incyte announced positive topline results from its randomized, vehicle-controlled, pivotal Phase III TRuE-AD2 study evaluating the safety and efficacy of ruxolitinib cream in adolescent and adult patients (age greater than 12 years) with atopic dermatitis (AD). The study, part of the TRuE-AD clinical trial program, met its primary endpoint. Significantly more patients treated with ruxolitinib cream 0.75% and 1.5% achieved Investigator’s Global Assessment 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 at Week 8 – than patients treated with vehicle control (non-medicated cream). The overall efficacy and 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-AD2 will be submitted for presentation at an upcoming scientific meeting.