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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: 22 Dec 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

    • 16 Dec 2024 According to an Arcutis Biotherapeutics media release, based on results form INTEGUMENT-PED and INTEGUMENT-OLE trial, the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for ZORYVE (roflumilast) cream 0.05%, a once-daily, next generation phosphodiesterase 4 for the topical treatment of mild to moderate AD in children 2 to 5 years old.
    • 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.

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