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Arcutis enrolls first patient in Phase III trial of topical roflumilast foam as a potential treatment for scalp and body psoriasis.

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Published:26th Aug 2021
Arcutis Biotherapeutics, Inc. announced it had enrolled the first patient in its single Phase III clinical trial evaluating topical roflumilast foam (ARQ-154) as a potential treatment for scalp and body psoriasis.

Roflumilast foam is a once-daily topical foam formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor, which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis.

The “A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis” (ARRECTOR) study is a parallel group, double blind, vehicle-controlled pivotal Phase III study of the safety and efficacy of ARQ-154 0.3% foam or a matching vehicle administered once-daily in approximately 420 subjects with scalp and body psoriasis ages 12 and older. The co-primary endpoints of the study include 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. Based on prior discussions with the FDA, the Company believes that, if successful, this trial will provide sufficient basis to file a supplemental NDA for ARQ-154 in scalp and body psoriasis.

Condition: Psoriasis: Scalp
Type: drug

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