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Arcutis Announces Positive Topline Results from INTEGUMENT-1 Pivotal Phase 3 Trial of Roflumilast Cream in Atopic Dermatitis in Adults and Children Aged Six Years and Older

Last Updated on November 15, 2022 by GlobeNewsWire

WESTLAKE VILLAGE, Calif., Nov. 15, 2022 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced positive topline results from its INTEGUMENT-1 pivotal Phase 3 trial of roflumilast cream 0.15%, a once-daily, non-steroidal topical phosphodiesterase-4 (PDE4) inhibitor, in adults and children six years and older with mild to moderate atopic dermatitis (AD). The study met its primary endpoint with 32.0% of individuals treated with roflumilast cream 0.15% achieving IGA Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at Week 4, compared to 15.2% of individuals treated with vehicle (P<0.0001).

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