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

Incyte announced the positive review results from the pivotal study TRuE-AD3, randomized, vehicle-controlled, evaluating the safety and efficacy of ruxolitinib cream (Opzelura) in children ( ages 2 to < 12 years old) with atopic dermatitis.The study met the primary endpoint and showed more patients treated with ruxolitinib cream 0.75% and 1.5 achieved Investigator Global Review Treatment Success (IGA-TS)) significantly compared with patients treated with the control vehicle (drug-free cream). The Investigator’s Global Assessment of Treatment Success (IGA-TS) was defined as an IGA score of 0 (obvious) or 1 (almost obvious) with an improvement of at least two points from baseline. at week 8. The overall safety profile of ruxolitinib cream was consistent with previous data and no new safety signal was 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,”
“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.”
Jim Lee, M.D., Group Vice President, Inflammation & AutoImmunity, Incyte.
The TRuE-AD3 data will be submitted for presentation at an upcoming scientific meeting.AD – the most common type of eczema – is a chronic skin disease that, in the United States, affects approximately 2 to 3 million patients 2 to 11 years old and more than 21 million people 12 years of age and older. It is characterized by inflammation and itching. Signs and symptoms include irritated, itchy skin, which can cause red sores that can ooze and crust over. People with AD are also more susceptible to bacterial, viral, and fungal infections3.
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