Enrollment in ARRECTOR Pivotal Phase 3 Trial Completed

The ARRECTOR pivotal phase 3 trial (NCT05028582) finished enrollment on April 6, 2022. Its purpose is to determine the efficacy and safety of topical roflumilast foam (ARQ-154, Arcutis Biotherapeutics Inc) as a treatment in adolescent and adult patients with scalp and body psoriasis. Roflumilast foam is a selective and highly potent phosphodiesterase-4 (PDE4) inhibitor and was formulated for use on all areas of the body.

Arcutis Biotherapeutics, in the press release, stated it believes the trial will give the basis to file a New Drug Application (sNDA) with the FDA for roflumilast foam in both scalp and body psoriasis.

“The scalp and hair-bearing areas of the body create unique treatment challenges, not easily solved through creams or ointments, and often requiring patients to use multiple therapies, complicated treatment regimens or resort to expensive systemic or biologic therapies. This can result in lack of compliance to treatment and worsening symptoms. Roflumilast foam has been formulated to overcome these challenges and provide a once-daily treatment option for use on all areas of the body,” said Patrick Burnett, MD, PhD, FAAD, in the press release. “We are proud of the continued execution of our clinical development program as demonstrated by the completion of enrollment in a second pivotal phase 3 program for roflumilast foam this year. More importantly, we move one step closer to providing an important treatment option to millions of individuals impacted by scalp psoriasis.”

Reference:

Arcutis completes enrollment in arrector pivotal phase 3 trial of topical roflumilast foam in scalp and body psoriasis. Arcutis Biotherapeutics. Published April 6, 2022. Accessed April 19, 2022. https://www.arcutis.com/arcutis-completes-enrollment-in-arrector-pivotal-phase-3-trial-of-topical-roflumilast-foam-in-scalp-and-body-psoriasis/