Arcutis Initiates Pivotal Phase 3 Clinical Trials Evaluating Topical Roflumilast Cream (ARQ-151) as a Potential Treatment for Atopic Dermatitis - Seite 2

The “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis” 1 and 2 (or INTEGUMENT-1 and -2) are identical Phase 3, parallel group, double blind, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle is applied once daily for 4 weeks to subjects 6 years of age and older with mild to moderate AD involving ≥3% body surface area.

In each trial, approximately 650 subjects are planned to be randomized 2:1 to either roflumilast cream 0.15% or matching vehicle cream. The primary endpoint of both trials 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. After completing INTEGUMENT-1 or -2, subjects may be eligible to enroll in a 12‑month, open label extension study (INTEGUMENT-OLE) evaluating once daily roflumilast cream. The Company anticipates topline data from INTEGUMENT-1 and -2 in the second half of 2022.

Arcutis also plans to initiate a third pivotal Phase 3 study, the “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients” (or INTEGUMENT-PED) shortly to evaluate roflumilast cream in subjects 2 to 5 years of age with mild to moderate AD.

About Atopic Dermatitis
Atopic dermatitis (AD) is the most common type of eczema, occurring in approximately 6% of the U.S. population. AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. This reaction produces a red, itchy rash, most frequently occurring on the face, arms and legs, and the rash can cover significant areas of the body, in some cases half of the body or more. Disease onset is most common by 5 years of age, and the Company estimates that approximately 60% of patients suffering from AD are pediatric patients. The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing. Given that most of the patients are pediatric, the safety and tolerability of AD therapies is paramount.