Arcutis Reports P-III (ARRECTOR) Trial Results of Roflumilast Foam for the Treatment of Scalp and Body Psoriasis
Shots:
- The P-III (ARRECTOR) trial evaluating roflumilast foam (0.3%) vs vehicle in 432 patients aged ≥12yrs. with scalp & body psoriasis
- The study met co-primary EPs & 2EPs i.e., 67.3% vs 28.1% of patients achieved S-IGA success @8wk., 46.5% vs 20.8% achieved B-IGA success. The therapy also showed an improvement on all 2EPs incl. scalp itch & overall itch as measured by SI-NRS & WI-NRS @8wk., was well-tolerated, & the overall safety and tolerability profile was consistent with prior studies, the incidence of TEAEs was low, and similar b/w active treatment & vehicle
- AEs leads to treatment discontinuation (2.5% vs 1.3%). The company plans to submit an NDA of roflumilast foam to the US FDA for seborrheic dermatitis in Q1’23
Ref: GlobeNewswire | Image: Arcutis
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