Arcutis initiates phase 3 trial of roflumilast foam for scalp, body psoriasis

The first patient has been enrolled in a phase 3 clinical trial of topical roflumilast foam for the treatment of scalp and body psoriasis, Arcutis Biotherapeutics announced in a press release.

Roflumilast foam (ARQ-154), a once-daily formulation of a highly potent and selective phosphodiesterase type 4 inhibitor, is in development for both psoriasis and seborrheic dermatitis.

The parallel-group, double-blind, vehicle-controlled pivotal ARRECTOR study is evaluating the safety and efficacy of ARQ-154 0.3% foam compared with vehicle in approximately 420 patients aged 12 years and older with scalp and body psoriasis.

The study’s co-primary endpoints are scalp and body Investigator’s Global Assessment scores of clear or almost clear, plus a two-point improvement from baseline after 8 weeks.

“One challenge for patients with scalp psoriasis is that they often require two or more medications for different areas of the body to manage their disease,” Patrick Burnett, PhD, MD, FAAD, chief medical officer of Arcutis, said in the release. “We are pleased to initiate this phase 3 trial, as we believe roflumilast foam, if approved, may represent a much-needed, new standard of care for people with scalp and body psoriasis that is suitable for use in hair-bearing areas, unlike creams and ointments, and does not pose the safety concerns typically seen with topical steroids.”