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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 0.15% 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 0.15% Administered QD in Subjects With Atopic Dermatitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jul 2024

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At a glance

  • Drugs Roflumilast (Primary)
  • Indications Atopic dermatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms INTEGUMENT-2
  • Sponsors Arcutis Biotherapeutics
  • Most Recent Events

    • 10 Jul 2024 According to an Arcutis Biotherapeutics media release, based on positive results from phase 3 studies (INTEGUMENT-1 and INTEGUMENT-2) , US FDA approved the supplemental new drug application (sNDA) for roflumilast cream, 0.15% (Zoryve) for the treatment of mild to moderate atopic dermatitis (AD) in adult and pediatric patients aged 6 years and older.
    • 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
    • 05 Jun 2024 According to an Arcutis Biotherapeutics media release, data from this trial will be presented at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference
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