Arcutis Completes Enrollment in Phase 3 Trial of Topical Roflumilast Foam in Scalp and Body Psoriasis

April 8, 2022

If successful, the Company believes that this trial will provide sufficient basis to file a supplemental New Drug Application (sNDA) in the U.S. for roflumilast foam in scalp and body psoriasis.

Enrollment in Arcutis’ ARRECTOR pivotal Phase 3 trial of topical roflumilast foam in adolescents and adults with scalp and body psoriasis is complete, the company reported.

Roflumilast foam is a once-daily, topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor (roflumilast). The foam formulation was designed to treat all areas of the body, including the face and particularly hair-bearing areas such as the scalp. 

Topline data is anticipated in late Q3/early Q4 2022. If successful, the Company believes that this trial will provide sufficient basis to file a supplemental New Drug Application (sNDA) in the U.S. for roflumilast foam in 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,” says Arcutis’ chief medical officer Patrick Burnett, MD, PhD, FAAD. “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.”

About ARRECTOR
The “A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis” (ARRECTOR) study is a parallel group, double blind, vehicle-controlled pivotal Phase 3 study of the safety and efficacy of roflumilast foam 0.3% or a matching vehicle administered once-daily in subjects with scalp and body psoriasis ages 12 and older. A total of 432 subjects have enrolled in the study. The co-primary endpoints of the study are the proportion of subjects achieving Scalp-Investigator’s Global Assessment (IGA) success and the proportion of subjects achieving Body-IGA success, with IGA success defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement from baseline after eight weeks.

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