Arcutis Biotherapeutics, Inc. initiated a pivotal Phase 3 clinical trial evaluating topical roflumilast cream (ARQ-151) as a potential treatment for mild to moderate atopic dermatitis (AD) in patients between the ages of 2 and 5 years old. Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), which the Company is developing for plaque psoriasis and AD.

“Young children suffering from atopic dermatitis often struggle with intense, persistent itching that can lead to damage caused by scratching, and that can negatively impact quality of life for both the child and the caregiver,” says Patrick Burnett, MD, PhD, FAAD, Arcutis’ Chief Medical Officer, in a news release. “Since the majority of atopic dermatitis patients are children, safety is particularly important. We are pleased to initiate this pivotal Phase 3 trial because we believe topical roflumilast has the
potential to eliminate the need to compromise between safety, tolerability, and efficacy. In clinical trials, roflumilast cream has demonstrated a favorable safety and tolerability profile, and importantly, unlike steroids, it is safe to use chronically. In a previous Phase 2 trial, topical roflumilast has also shown encouraging efficacy in adult patients with atopic dermatitis. If approved, roflumilast cream may offer an additional treatment option to physicians and parents with otherwise limited choices.”

The “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients” (or INTEGUMENT-PED) is a Phase 3, parallel group, double blind, vehicle-controlled trial in which roflumilast cream 0.05% or vehicle is applied once daily for four weeks to patients between the ages of 2 and 5 years old with mild to moderate AD involving ≥3% body surface area (excluding the scalp, palms, soles).

In the trial, approximately 650 subjects will be randomized 2:1 to either roflumilast cream 0.05% or matching vehicle cream. The primary endpoint of the trial 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 percent reduction in the Eczema Area and Severity Index (EASI-75) at Week 4. The Company anticipates topline data from INTEGUMENT-PED in the second half of 2022.

Arcutis recently initiated two other pivotal Phase 3 trials (INTEGUMENT-1 and -2), which 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.