Arcutis Biotherapeutics completes enrollment in ITNEGUMENT-PED Phase 3 trial

Arcutis Biotherapeutics announced the enrollment of the last subject in the INTEGUMENT-PED Pivotal Phase 3 trial evaluating roflumilast cream 0.05% for the treatment of mild to moderate AD 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, 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 3 trials of roflumilast cream 0.15% in ages 6 and above. "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.