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A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% Administered QD in Subjects With Atopic Dermatitis

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Trial Profile

A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% Administered QD in Subjects With Atopic Dermatitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Aug 2024

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At a glance

  • Drugs Roflumilast (Primary)
  • Indications Atopic dermatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms INTEGUMENT-PED
  • Sponsors Arcutis Biotherapeutics

    • Most Recent Events

    • 28 Aug 2024 According to an Arcutis Biotherapeutics media release, company intends to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2025 for roflumilast cream 0.05% for the treatment of AD in individuals ages 2-5 years.
    • 28 Aug 2024 Results published in an Arcutis Biotherapeutics media release.
    • 09 Jul 2024 According to an Arcutis Biotherapeutics media release, company has been in communication with the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) for adults and children down to the age of 6. The FDA has indicated that they are working to finalize the action letter and have not indicated they would extend the PDUFA goal date of July 7, 2024

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