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A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects With Atopic Dermatitis

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Trial Profile

A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects With Atopic Dermatitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jun 2025

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At a glance

  • Drugs Roflumilast (Primary)
  • Indications Atopic dermatitis
  • Focus Adverse reactions; Registrational
  • Acronyms INTEGUMENT-OLE
  • Sponsors Arcutis Biotherapeutics

Most Recent Events

  • 06 Jun 2025 According to an Arcutis Biotherapeutics media release, the data from this study will be presented at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference, which is taking place in Nashville, TN, from June 6-7, 2025.
  • 17 Mar 2025 According to an Arcutis Biotherapeutics media release, Health Canada has approved PrZORYVE (roflumilast cream 0.15%), for the treatment of mild to moderate atopic dermatitis (AD) in adults and children ages 6 years and older. The approval of ZORYVE cream 0.15% for atopic dermatitis in Canada was supported by positive results from the vehicle-controlled pivotal Phase 3 INTEGUMENT-1, INTEGUMENT-2 trials and additional data from INTEGUMENT-OLE trial.
  • 26 Feb 2025 According to an Arcutis Biotherapeutics media release, company announced the FDAs acceptance of a supplemental New Drug Application (sNDA) for?ZORYVE (roflumilast) cream 0.05%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the topical treatment of mild to moderate AD in children 2 to 5 years old. The FDA has set a PDUFA target action date of October 13, 2025 for this application

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