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A Randomized tRial Employing topiCal roflumilasT Foam to Treat Scalp Psoriasis (ARRECTOR)

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Trial Profile

A Randomized tRial Employing topiCal roflumilasT Foam to Treat Scalp Psoriasis (ARRECTOR)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2024

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At a glance

  • Drugs Roflumilast (Primary)
  • Indications Psoriasis
  • Focus Registrational; Therapeutic Use
  • Acronyms ARRECTOR
  • Sponsors Arcutis Biotherapeutics

    • Most Recent Events

    • 06 Nov 2024 According to an Arcutis Biotherapeutics media release, submitted sNDA for ZORYVE foam for scalp and body psoriasis to the FDA based on the positive results from the pivotal ARRECTOR Phase 3 trial and a Phase 2b trial, was accepted by the FDA in September with a PDUFA action date set for May 22, 2025.
    • 24 Sep 2024 According to an Arcutis Biotherapeutics media release, announced the FDA has accepted its sNDA for ZORYVE (roflumilast) foam 0.3%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis. The FDA assigned the application a PDUFA target action date of May 22, 2025 on basis of result of this trial.
    • 23 Jul 2024 According to an Arcutis Biotherapeutics media release, the company announced submission of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam 0.3%, a once-daily,for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis.

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