Enrollment in INTEGUMENT-PED pivotal phase III trial of roflumilast cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5

Roflumilast cream is a once-daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), which the Company is evaluating in two doses for AD: 0.15% for adults and children 6 years of age and older, and 0.05% for children aged 2 to 5 years. Arcutis previously reported positive topline data in similarly designed Pivotal Phase III trials of roflumilast cream 0.15% in ages 6 and above.

AD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States. Topical therapies are an important treatment option for the majority of individuals who use pharmaceuticals to treat their disease.

“Topical steroids are the first-line of treatment for AD in children, and there are few treatment options available for chronic use. It was critical for Arcutis that we developed and studied the effectiveness and safety of roflumilast cream in children as young as age 2 because of the tremendous burden AD can represent, including lack of sleep and persistent itch,” said Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer at Arcutis. “Roflumilast cream is a once-daily, steroid free treatment that was formulated to be a non-greasy, moisturizing cream that absorbs quickly. In addition, roflumilast cream does not include sensitizing excipients or irritants such as propylene glycol.”

The Company plans to report topline data for the INTEGUMENT-PED trial in the third quarter 2023. If successful, the Company expects these data to be sufficient basis for a separate supplemental new drug application (sNDA) submission after the approval of roflumilast cream 0.15% in AD for ages 6 and above. Arcutis plans to submit the new drug application (NDA) for roflumilast cream 0.15% for adults and children age 6 and older in the second half of 2023.

About INTEGUMENT-PED : The “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients” (INTEGUMENT-PED) is a Phase III, parallel group, double blind, vehicle-controlled trial in which roflumilast cream 0.05% or vehicle is applied once-daily for four weeks to children 2 to 5 years of age with mild to moderate AD. A total of 652 individuals have been enrolled in the study. 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.