Arcutis Announces Phase 3 Trial of ZORYVE Cream 0.3% for Moderate to Severe Atopic Dermatitis

Arcutis Biotherapeutics has enrolled the first participant in INTEGUMENT-3, a Phase 3 clinical trial evaluating ZORYVE (roflumilast) cream 0.3% for moderate to severe atopic dermatitis in children and adults aged 6 years and older.

The randomized, double-blind, vehicle-controlled study will assess the efficacy, safety, and tolerability of the higher-concentration topical phosphodiesterase-4 (PDE4) inhibitor, potentially expanding treatment options for patients with more severe atopic dermatitis.

INTEGUMENT-3 Study Design and Endpoints

INTEGUMENT-3 (ARQ-151-323) is a multicenter study expected to enroll approximately 415 participants aged 6 years and older with moderate to severe atopic dermatitis. Eligible participants must have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 3 or 4, an Eczema Area and Severity Index (EASI) score of at least 5, and 3% to 30% body surface area involvement.

Participants will be randomized 2:1 to receive once-daily ZORYVE cream 0.3% or matching vehicle for 4 weeks. The study will evaluate treatment efficacy and safety during this initial period.

Participants completing the double-blind phase may enter a 48-week open-label extension, during which all participants will receive ZORYVE cream 0.3%. The extension will assess long-term safety, tolerability, and efficacy over a total treatment period of up to 52 weeks.

Potential Expansion of ZORYVE in Atopic Dermatitis

ZORYVE cream is already available in lower concentrations for mild to moderate atopic dermatitis, including 0.15% for patients aged 6 years and older and 0.05% for children aged 2 to 5 years. According to Arcutis, the investigational 0.3% formulation could provide another nonsteroidal topical treatment option for patients with moderate to severe disease.

Source

Arcutis press release. November 5, 2026.