Arcutis Reports P-III (INTEGUMENT-1) Trial Results of Roflumilast Cream for Atopic Dermatitis in Adults and Children Aged ≥6 Years
Shots:
- The P-III (INTEGUMENT-1) trial evaluating roflumilast (0.15%, qd) vs vehicle in 654 patients aged ≥6yrs. with AD
- The trial met its 1EPs i.e., 32.0% vs 15.2% of patients achieved IGA success & 2-grade improvement from baseline @4wk., improvements on all 2EPs, incl. 43.2% achieved a 75% vs 22.0% reduction in EASI-75 @4wk., 33.6% vs 20.7% achieved a 4-point reduction in WI-NRS @4wk., was well-tolerated, TEAEs was low & similar b/w active treatment & vehicle with no treatment-related SAEs, few discontinuations due to AEs (1.4% vs 1.4%) along with a favorable safety and tolerability profile
- The P-III (INTEGUMENT-2) trial results are expected at the end of 2022. The company plans to submit an sNDA of roflumilast cream in 2023
Ref: Globenewswire | Image: Arcutis
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