Arcutis Concludes Dosing In Late-Stage Itchy Skin Study, Anticipates Regulatory Submission By Next Year

Arcutis Biotherapeutics ARQT has completed the enrollment of subject in its INTEGUMENT-2 pivotal Phase 3 trial of roflumilast cream 0.15% in adults and children with Atopic dermatitis (AD).

The INTEGUMENT-2 study is the second of two Phase 3 clinical trials in which roflumilast cream 0.15% or vehicle is applied once daily for four weeks to individuals six years of age and older with mild to moderate Atopic dermatitis (AD).

A total of 683 individuals have been enrolled in this study.

Arcutis recently completed enrollment in an identically designed pivotal Phase 3 trial, INTEGUMENT-1.

Topline data readout from both the trials are expected by end of this year.

Patrick Burnett, Chief Medical Officer, said, "We are excited to have completed enrollment in the second of two phase 3 pivotal trials with roflumilast cream 0.15% in individuals with atopic dermatitis age six years and older, just weeks after closing enrollment for INTEGUMENT-1. We believe there is a large unmet need for a once-daily non-steroidal therapy for atopic dermatitis that is effective and well-tolerated, and investigational roflumilast cream has the potential to fill this need."

Upon successful clinical results, the trials will provide a sufficient basis for the company to submit a supplemental New Drug Application (sNDA) for roflumilast cream 0.15% for the treatment of mild to moderate AD in individuals six years of age and older in 2023.

Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States.

Price Action : Arcutis shares closed Monday’s trading down 1.6 percent at $25.27