Incyte announced positive topline results from its randomized, vehicle-controlled, pivotal Phase 3 TRuE-AD2 study evaluating the safety and efficacy of ruxolitinib cream in adolescent and adult patients (age ≥ 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.
“This positive topline result reinforces the potential of ruxolitinib cream, if approved, to offer AD patients a much-needed effective, non-steroidal therapy,” said Jim Lee, M.D., Group Vice President, Inflammation & AutoImmunity, Incyte. “We look forward to the results of the TRuE-AD1 trial, the second study in the pivotal clinical trial program, later this quarter, and to sharing these data with the medical community as part of our commitment to develop a new first-line treatment option for these patients.”
Data from TRuE-AD2 will be submitted for presentation at an upcoming scientific meeting.
AD is a common chronic disease characterized by inflammation of the skin. At least 11 million people in the United States have been diagnosed with and are being treated for AD. The majority of these patients have a mild or moderate form of the disease and approximately 80% are adults or adolescents. Signs and symptoms of AD include irritated and itchy skin that can cause red lesions that may ooze and crust. Patients with AD are also more susceptible to bacterial, viral and fungal infections.