Arcutis' INTEGUMENT-PED Phase 3 Study Of Roflumilast Cream 0.05% Meets Primary Goal

(RTTNews) - Arcutis Biotherapeutics, Inc. (ARQT) Tuesday said that INTEGUMENT-PED, the company's pivotal Phase 3 study of roflumilast cream 0.05% to treat mild to moderate atopic dermatitis (AD) in children ages 2 to 5 years met its primary goal.

Atopic dermatitis is a chronic skin condition that causes itchy rashes and inflammation.

INTEGUMENT-PED, a vehicle-controlled trial, in which Roflumilast cream 0.05% or vehicle was applied once daily for four weeks to children 2 to 5 years of age with mild to moderate AD. The study enrolled 652 children.

The primary endpoint of the study was Investigator Global Assessment (IGA) Success, defined as a vIGA-AD score of "clear" or "almost clear" plus a 2-grade improvement from baseline at Week 4.

At week 4, 25.4% of children treated with roflumilast cream 0.05% achieved IGA Success compared to 10.7% of children treated with vehicle. Significant improvements were seen as early as Week 1.

The data from this study is highly consistent with the findings from INTEGUMENT-1 and INTEGUMENT-2 pivotal studies.

The company has recently submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis in adults and children ages 6 years and older.