Incyte says Phase 3 TruE-AD3 study meets primary endpoint

Incyte announced positive topline results from its randomized, vehicle-controlled, pivotal Phase 3 TRuE-AD3 study evaluating the safety and efficacy of ruxolitinib cream in children with atopic dermatitis. 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 than patients treated with vehicle control. Investigator’s Global Assessment Treatment Success is defined as an IGA score of 0 or 1 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. “AD is a chronic, immune-mediated skin condition that affects about 13% of all children in the U.S. It can cause disruptive symptoms like redness, dry skin and intense itch, which can detrimentally impact quality of life and be difficult to manage for both the child and their caregivers,” said Jim Lee, M.D., Group Vice President, Inflammation & AutoImmunity, Incyte. “We have already seen the benefit that ruxolitinib cream can have among adult and adolescent patients with atopic dermatitis in the TRuE-AD1 and TRuE-AD2 studies, and this new positive data reinforces the potential of ruxolitinib cream to offer children a much-needed effective, non-steroidal topical therapy. We look forward to discussing these data with regulatory agencies to determine next steps.”