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Arcutis Reports P-III (INTEGUMENT-1) Trial Results of Roflumilast Cream for Atopic Dermatitis in Adults and Children Aged ≥6 Years

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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

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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