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Phase 3 Trials Initiated for Topical Roflumilast Cream in AD


Arcutis Biotherapeutics announces the commencement of two identical phase 3 clinical trials evaluating topical PDE4 inhibitor roflumilast cream in patients with mild-to-moderate atopic dermatitis.

Arcutis Biotherapeutics announces it has initiated a phase 3 clinical trial evaluating topical roflumilast cream (ARQ-151, Arcutis Biotherapeutics) for the treatments of atopic dermatitis (AD).

Roflumilast cream is a once-daily topical phosphodiesterase type 4 inhibitor (PDE4) defined as an intracellular enzyme that increases production of pro-inflammatory mediators while decreasing production of anti-inflammatory mediators.

The enzyme has been linked to a variety of inflammatory diseases including AD, psoriasis and chronic obstructive pulmonary disease (COPD). Roflumilast cream has the potential to be a “Best in Class” topical PDE4 inhibitor, according to a company press release.1

“More than 19 million people in the U.S. suffer from AD, of which at least 60 percent [sic] are young children, thereby making safety and tolerability particularly important in this disease,” says Patrick Burnett, MD, PhD, FAAD, Arcutis’ chief medical officer. “Atopic dermatitis is characterized by a defect in the skin barrier, which results in a red, itchy rash that in many cases can cover significant areas of the body. Current treatments often fall short, resulting in patients, parents and physicians having to make trade-offs between efficacy, safety and tolerability.”

The INTEGUMENT 1 and 2 (INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis) studies are identical, parallel group, double blind and vehicle-controlled phase 3 clinical trials. Each trial will evaluate roflumilast cream 0.15% or vehicle once-daily for 4 weeks in 650 patients ages six years and older with mild-to-moderate AD involving ≥3% body surface area.

The primary endpoint of the studies is Investigator Global Assessment (IGA) Success, which is defined as a Validated Investigator Global Assessment - Atopic Dermatitis (vIGA-AD) score of clear or almost clear, as well as a 2-grade improvement from baseline at Week 4. Various secondary endpoints will also be assessed, including itch, measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and proportion of participants who achieve at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) at Week 4.

Following the completion of INTEGUMENT 1 or 2, patients will have the option to enroll in a 12-month, open label extension study (INTEGUMENT-OLE). Additionally, the company has plans to commence a third phase 3 study (INTEGUMENT-PED), evaluating roflumilast cream in pediatric patients two to five years of age with mild-to-moderate AD, according to Arcutis.

“We are excited to begin our pivotal Phase 3 trials in patients with atopic dermatitis,” says Burnett. “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. 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.”


1. Arcutis initiates pivotal phase 3 clinical trials evaluating topical roflumilast cream (ARQ-151) as a potential treatment for atopic dermatitis - arcutis biotherapeutics. Accessed January 19, 2021. https://investors.arcutis.com/news-releases/news-release-details/arcutis-initiates-pivotal-phase-3-clinical-trials-evaluating/

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