Arcutis Finalizes Enrollment in Pivotal Phase 3 Trial of Roflumilast Cream for AD

INTEGUMENT-1 and 2 trial data for atopic dermatitis are expected at the end of 2022.

Arcutis Biotherapeutics, a biopharmaceutical company that develops therapies in immuno-dermatology, has completed the enrollment of participants in its INTEGUMENT-2 pivotal phase 3 trial of roflumilast cream 0.15%.1 If data from both trials are successful, the trials will provide a sufficient basis to submit a supplemental New Drug Application (sNDA) in 2023 for the treatment of mild-to-moderate atopic dermatitis (AD) in patients aged 6 years and older.

INTEGUMENT-2 includes 683 adults and children with AD. INTEGUMENT-1 enrollment was finalized in early August 2022 and was an identically designed pivotal phase 3 trial. After completing both clinical trials, participants will be eligible to enroll in an open-label extension study (INTEGUMENT-OLE) which evaluates AD treatment with once-daily roflumilast cream 0.15% for up to 12 months.

The “Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis” 2 (INTEGUMENT-2) is a phase 3, parallel group, double blind, vehicle-controlled trial designed to monitor the safety and efficacy of roflumilast cream 0.15% or vehicle applied once daily for 4 weeks to participants 6 years of age and older with mild-to-moderate AD. Roflumilast cream 0.15% is a topical formulation of roflumilast applied once a day, and a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4).

According to Arcutis, “The primary endpoint is Investigator Global Assessment (IGA) Success, defined as a Validated Investigator Global Assessment – Atopic Dermatitis (vIGA- AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. Multiple secondary endpoints will also be evaluated, including itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS) as well as the proportion of subjects who attain at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) at week 4.”

AD affects more than 9.6 million children and 16.5 million adults in the US as the most common type of eczema.2 As a chronic condition, it can flare up at any time and even overlap with other types of eczema. AD typically appears during childhood, as early as 6 months old. In some patients, symptoms may reduce over time, while others will experience severe flare ups into adulthood.

Reference:

  1. Arcutis completes enrollment in integument-2 pivotal phase 3 trial of roflumilast cream in atopic dermatitis. Arcutis Biotherapeutics. Published August 23, 2022. Accessed August 24, 2022. https://www.arcutis.com/arcutis-completes-enrollment-in-integument-2-pivotal-phase-3-trial-of-roflumilast-cream-in-atopic-dermatitis/
  2. What is atopic dermatitis and how can I tell if I have it? National Eczema Association. Accessed August 24, 2022. https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/