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Arcutis Completes Enrollment in ARRECTOR Pivotal Phase 3 Trial of Topical Roflumilast Foam in Scalp and Body Psoriasis
Topline data anticipated in late Q3/early Q4A total of 432 subjects are enrolled in the ARRECTOR studyArcutis progressing topical roflumilast in four
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Topline data anticipated in late Q3/early Q4A total of 432 subjects are enrolled in the ARRECTOR studyArcutis progressing topical roflumilast in four dermatological indicationsOver 3 million patients in the U.S. have plaque psoriasis in the scalp WESTLAKE VILLAGE, Calif., April 06, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the enrollment of the last subject in its ARRECTOR pivotal Phase 3 trial of topical roflumilast foam in adolescents and adults with scalp and body psoriasis. Roflumilast foam is a once-daily, topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor (roflumilast). The foam formulation was designed to treat all areas of the body, including the face and particularly hair-bearing areas such as the scalp. If successful, the Company believes that this trial will provide sufficient basis to file a supplemental New Drug Application (sNDA) in the U.S. for roflumilast foam in scalp and body psoriasis. Scalp psoriasis occurs in approximately 40% of individuals with plaque psoriasis and can cause physical and emotional distress, with 97% of individuals with scalp psoriasis reporting that the condition impacts their daily life. i “The scalp and hair-bearing areas of the body create unique treatment challenges, not easily solved through creams or ointments, and often requiring patients to use multiple therapies, complicated treatment regimens or resort to expensive systemic or biologic therapies. This can result in lack of compliance to treatment and worsening symptoms. Roflumilast foam has been formulated to overcome these challenges and provide a once-daily treatment option for use on all areas of the body,” said Patrick Burnett, MD, PhD, FAAD. “We are proud of the continued execution of our clinical development program as demonstrated by the completion of enrollment in a second pivotal phase 3 program for roflumilast foam this year. More importantly, we move one step closer to providing an important treatment option to millions of individuals impacted by scalp psoriasis.” About ARRECTORThe “A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis” (ARRECTOR) study is a parallel group, double blind, vehicle-controlled ...