Arcutis initiates phase 3 trials of roflumilast cream for atopic dermatitis

Arcutis Biotherapeutics has begun two phase 3 trials of topical roflumilast cream for the treatment of atopic dermatitis.

Once-daily roflumilast cream (ARQ-151), a PDE4 inhibitor, is in development for the treatment of plaque psoriasis and atopic dermatitis.

The identical phase 3 parallel-group, double-blind, vehicle-controlled trials will each include approximately 650 subjects randomly assigned 2:1 to receive roflumilast 0.15% or vehicle.

Primary endpoints for both arms of the INTEGUMENT-1 and -2 trials will be Investigator Global Assessment scores of “clear” or “almost clear,” as well as a two-grade improvement from baseline, after 4 weeks.

“We are excited to begin our pivotal phase 3 trials in patients with atopic dermatitis. If approved, roflumilast cream would be the first once-a-day topical nonsteroidal treatment for AD and would also offer patients a cosmetically elegant, non-greasy formulation. In clinical trials, roflumilast cream has demonstrated a benign safety and tolerability profile, without the local tolerability or safety issues associated with many other topical AD treatments, and importantly, unlike steroids, it can safely be used chronically,” Patrick Burnett, MD, PhD, FAAD, Arcutis’ chief medical officer, said in a press release. “We believe topical roflumilast has the potential to eliminate the need to compromise between safety, efficacy and tolerability, and we look forward to reporting topline data in the second half of 2022.”

A third pivotal phase 3 study, INTEGUMENT-PED, which will evaluate the drug’s efficacy in children aged 2 to 5 years with mild to moderate AD, is expected to begin soon.