Arcutis Completes Enrollment in Pivotal Phase 3 Roflumilast AD Trial

August 5, 2022
Arcutis Completes Enrollment in Pivotal Phase 3 Roflumilast AD Trial image

Arcutis Biotherapeutics, Inc. has completed 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). Arcutis 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 says it 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 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.”

The “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis” 1 (INTEGUMENT-1) is a Phase 3, parallel group, double blind, vehicle-controlled trial in which roflumilast cream 0.15% or vehicle is applied once daily for four weeks to individuals six years of age and older with mild to moderate AD involving ≥3% body surface area. A total of 654 individuals have been enrolled in the study. The primary endpoint is Investigator Global Assessment (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. Multiple secondary endpoints will also be evaluated, including itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS) as well as the proportion of subjects who attain at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) at Week 4.

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.

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