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Arcutis Completes Enrollment in INTEGUMENT-PED Pivotal Phase 3 Trial of Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
A total of 652 children, ages 2 to 5, were enrolled in the studyTopline data expected in the third quarterAtopic dermatitis (AD) affects approximately 26
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"A total of 652 children, ages 2 to 5, were enrolled in the studyTopline data expected in the third quarterAtopic dermatitis (AD) affects approximately 26 million adults and children in the United States WESTLAKE VILLAGE, Calif., May 02, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immune-dermatology, today announced the enrollment of the last subject in the INTEGUMENT-PED Pivotal Phase 3 trial evaluating roflumilast cream 0.05% for the treatment of mild to moderate AD in children ages 2 to 5. Roflumilast cream is a once-daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), which the Company is evaluating in two doses for AD: 0.15% for adults and children 6 years of age and older, and 0.05% for children aged 2 to 5 years. Arcutis previously reported positive topline data in similarly designed Pivotal Phase 3 trials of roflumilast cream 0.15% in ages 6 and above. AD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States. Topical therapies are an important treatment option for the majority of individuals who use pharmaceuticals to treat their disease. “Topical steroids are the first-line of treatment for AD in children, and there are few treatment options available for chronic use. It was critical for Arcutis that we developed and studied the effectiveness and safety of roflumilast cream in children as young as age 2 because of the tremendous burden AD can represent, including lack of sleep and persistent itch,” said Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer at Arcutis. “Roflumilast cream is a once-daily, steroid free treatment that was formulated to be a non-greasy, moisturizing cream that absorbs quickly. In addition, roflumilast cream does not include sensitizing excipients or irritants such as propylene glycol.” The Company plans to report topline data for the INTEGUMENT-PED trial in the third quarter 2023. If successful, the Company expects these data to be sufficient basis for a separate supplemental new drug application (sNDA) submission after the approval of roflumilast cream 0.15% in AD for ages 6 and above. Arcutis plans to submit the new drug application (N...