Arcutis Completes Enrollment in INTEGUMENT-1 Pivotal Phase 3 Trial of Roflumilast Cream in Atopic Dermatitis
WESTLAKE VILLAGE, Calif., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the enrollment of the last subject in its INTEGUMENT-1 pivotal Phase 3 trial of roflumilast cream 0.15% in adults and children with atopic dermatitis (AD). Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4). The Company is continuing enrollment in an identically designed pivotal Phase 3 trial, INTEGUMENT-2, with topline data from both trials expected by end of 2022. If successful, the Company believes that the trials will provide a sufficient basis to submit a supplemental New Drug Application (sNDA) for roflumilast cream 0.15% for the treatment of mild to moderate AD in individuals age six years and older in 2023.
Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the U.S. Topical therapies are an important treatment option for the majority of individuals who use pharmaceuticals to treat their disease.
“Atopic dermatitis is a chronic condition that typically begins in childhood. The red, itchy rash most frequently occurs on sensitive areas such as the face, and on arms and legs,” said Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer at Arcutis. “We are pleased to have completed enrollment in the first of two phase 3 pivotal trials with roflumilast cream 0.15% in individuals with atopic dermatitis age six and older, moving Arcutis one step closer to potentially providing an important new treatment option for the millions of children and adults suffering from this disease. We believe roflumilast cream, if approved, has the potential to be an effective and well-tolerated once-daily non-steroidal therapy for individuals with atopic dermatitis.”
After completing INTEGUMENT-1 and INTEGUMENT-2, individuals may be eligible to enroll in an open label extension study (INTEGUMENT-OLE) evaluating treatment with once daily roflumilast cream 0.15% for up to 12 months.
Arcutis is enrolling a third pivotal Phase 3 trial, the “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients” (INTEGUMENT-PED) to evaluate roflumilast cream 0.05% in children two to five years of age with mild to moderate AD.
About Atopic Dermatitis
About Roflumilast Cream
Roflumilast cream 0.3% (ZORYVE™) was approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.