Arcutis reports positive Phase 3 results for roflumilast cream 0.15% in atopic dermatitis

Arcutis Biotherapeutics, Inc.

INTEGUMENT-1: 32.0% of roflumilast patients achieved IGA success vs 15.2% vehicle (p<0.0001); INTEGUMENT-2: 28.9% vs 12.0% (p<0.0001).
Key secondary endpoints met: EASI-75 (43.2% vs 22% in INTEGUMENT-1) and WI-NRS itch reduction (33.6% vs 20.7% in INTEGUMENT-1) at week 4.
Roflumilast cream was well-tolerated with low TEAEs; discontinuation rates low (<2%) in both trials.
Total 1,337 subjects enrolled across both trials (654 in INTEGUMENT-1, 683 in INTEGUMENT-2); completed study rates ~93% and 90%.
Company posted updated corporate presentation with trial details; results support potential NDA submission.

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