Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis

Condition(s) studied

Investigational drug(s) / intervention(s)

Roflumilast Cream 0.3%: Roflumilast cream 0.3% administered topically once daily to affected areas during the 4-week double-blind treatment period. Participants may continue treatment with roflumilast cream 0.3% during the 48-week open-label extension.

Vehicle Cream: Matching vehicle cream administered topically once daily to affected areas during the 4-week double-blind treatment period. Participants will receive roflumilast cream 0.3% during the open-label extension phase.

Study summary

This Phase 3 study is designed to evaluate the efficacy and safety of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis. Approximately 415 participants will be randomized in a 2:1 ratio to receive roflumilast cream 0.3% or matching vehicle cream during a 4-week double-blind, vehicle-controlled treatment period.

Following completion of the double-blind treatment period, all participants will enter a 48-week open-label extension and receive roflumilast cream 0.3%. The study will assess the efficacy of roflumilast cream 0.3% in improving signs and symptoms of atopic dermatitis and evaluate its long-term safety and tolerability through Week 52.

Eligibility

Primary outcome measure(s)

• Achievement of vIGA-AD Success at Week 4 — Week 4
  vIGA-AD Success is defined as achieving a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from Baseline.

Trial sites (1)

More Arcutis Biotherapeutics, Inc. trials in the USA

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