Roflumilast cream atopic dermatitis trial completes enrollment

Arcutis Biotherapeutics has completed patient enrollment for its phase 3 trial of roflumilast cream for the treatment of atopic dermatitis, the company announced in a press release.

The parallel group, double blind, vehicle controlled INTEGUMENT-1 trial includes 654 adults and children aged 6 years and older with at least 3% body surface area involvement of AD.

Participants will receive roflumilast cream 0.15%, a PDE4 inhibitor, or vehicle to apply once daily for four weeks.

“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,” Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer at Arcutis, said in the release. “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 6 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 nonsteroidal therapy for individuals with atopic dermatitis.”

The trial’s primary endpoint is an IGA score of clear or almost clear, plus a 2-grade approvement. Secondary endpoints include itch measured by the Worst Itch Numerical Rating scale and a reduction in EASI score.

Enrollment is continuing in an identical second phase 3 trial, INTEGUMENT-2.