A phase 3 trial evaluating the efficacy and safety of roflumilast foam in patients with scalp and body psoriasis met its coprimary and all secondary endpoints.

Roflumilast foam is an investigational topical formulation of a highly potent and selective phosphodiesterase type 4 inhibitor. The parallel group, double-blind, vehicle-controlled ARRECTOR study (ClinicalTrials.gov Identifier: NCT05028582) included 432 patients 12 years of age and older with scalp and body psoriasis. Patients were randomly assigned to receive either roflumilast foam 0.3% or vehicle once daily for 8 weeks.

The coprimary endpoints were the proportion of patients achieving Scalp Investigator Global Assessment (S-IGA) success and the proportion of patients achieving Body Investigator Global Assessment (B-IGA) success, with IGA Success defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement from baseline after 8 weeks.

Findings demonstrated that a greater proportion of patients treated with roflumilast foam achieved S-IGA success (67.3% vs 28.1%, respectively; P <.0001) and B-IGA success (46.5% vs 20.8%, respectively; P <.0001) at week 8 compared with those treated with vehicle. The study also met all secondary endpoints at week 8, including significant improvements in scalp itch as measured by Scalp Itch Numeric Rating Scale (SI-NRS) and overall itch as measured by Worst Itch NRS (WI-NRS).

The frequency of treatment emergent adverse events with roflumilast foam was low and similar to vehicle. Most treatment emergent adverse events were mild to moderate in severity and included headache, diarrhea, and COVID-19.

“Roflumilast foam provided significant clearance with a rapid onset of action on both the scalp and body as measured by S-IGA and B-IGA respectively,” said Melinda Gooderham, MSc, MD, FRCPC Medical Director, SKiN Centre for Dermatology, investigator with Probity Medical Research, and study author. “These data demonstrate that investigational roflumilast foam, if approved, could provide both an effective and well-tolerated new treatment option for scalp and body psoriasis.”

Roflumilast foam is also being evaluated for the treatment of moderate to severe seborrheic dermatitis. The Company plans to submit a New Drug Application to the Food and Drug Administration (FDA) for this indication in the first quarter of 2023.

The cream formulation of roflumilast is marketed under the brand name Zoryve for the treatment of plaque psoriasis.

Reference

Arcutis announces positive topline results from ARRECTOR pivotal phase 3 trial of roflumilast foam 0.3% in scalp and body psoriasis. News release. Arcutis Biotherapeutics, Inc. Accessed September 26, 2022. https://www.globenewswire.com/news-release/2022/09/26/2522479/0/en/Arcutis-Announces-Positive-Topline-Results-from-ARRECTOR-Pivotal-Phase-3-Trial-of-Roflumilast-Foam-0-3-in-Scalp-and-Body-Psoriasis.html