Arcutis Reports P-III Trial (INTEGUMENT-2) Results of Roflumilast for the Treatment of Atopic Dermatitis in Adults and Children Aged ≥6 Years
Shots:
- The P-III trial (INTEGUMENT-2) evaluates roflumilast (0.15%, qd for 4wks.) vs vehicle in 683 patients aged ≥6yrs. with mild to mod. AD
- The trial met its 1EPs & 2EPs i.e., 28.9% vs 12.0% of patients achieved IGA success defined as vIGA-AD score with 2-grade improvement from baseline @4wk., 42.0% vs 19.7% achieved a 75% improvement in EASI-75 @4wk., reduction in itch in patients aged ≥12yrs. & 30.2% vs 12.4% achieved a 4-point reduction in WI-NRS @4wk. The therapy was well tolerated, the incidence of TEAEs was low in both treatment arms, and AEs leading to treatment discontinuations (1.8% & 0.9%)
- The company plans to file an sNDA to the US FDA for roflumilast to treat AD in H2’23. The company also highlighted the P-III (INTEGUMENT-1) study results
Ref: Arcutis | Image: Arcutis
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