Incyte Announces Positive Topline Results from Phase 3 Trial Evaluating Ruxolitinib Cream (Opzelura) in Children with Atopic Dermatitis

Incyte (Nasdaq:INCY) today announced positive topline results from its randomized, vehicle-controlled, pivotal Phase 3 TRuE-AD3 study evaluating the safety and efficacy of ruxolitinib cream (Opzelura) in children (age ≥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.

"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."

Data from TRuE-AD3 will be submitted for presentation at an upcoming scientific meeting.

AD – the most common type of eczema – is a chronic skin disease, which in the U.S. affects an estimated 2-3 million patients ages 2-11 and more than 21 million people 12 years and older^1,2. It is characterized by inflammation and itch. Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust. People with AD are also more susceptible to bacterial, viral and fungal infections³.

About TRuE-AD3
TRuE-AD3 (NCT04921969) is a randomized, double-blind, vehicle-controlled Phase 3 study evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in children with atopic dermatitis (AD). The study enrolled over 300 patients (age ≥2 to <12 years) diagnosed with AD for at least 3 months and who were candidates for topical therapy.