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An Open Label, Phase 1, Maximal Usage Pharmacokinetics and Safety Study of ARQ-151 Cream 0.3% Administered QD in Adolescent and Adult Subjects With Chronic Plaque Psoriasis

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Trial Profile

An Open Label, Phase 1, Maximal Usage Pharmacokinetics and Safety Study of ARQ-151 Cream 0.3% Administered QD in Adolescent and Adult Subjects With Chronic Plaque Psoriasis

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Dec 2025

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At a glance

  • Drugs Roflumilast (Primary)
  • Indications Plaque psoriasis
  • Focus Pharmacokinetics
  • Acronyms MUSE
  • Sponsors Arcutis Biotherapeutics

Most Recent Events

  • 17 Nov 2025 According to an Arcutis Biotherapeutics media release, FDA Accepts supplemental New Drug Application for ZORYVE (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children Ages 2 to 5. And, The FDA has set a PDUFA target action date of June 29, 2026, for this application.
  • 03 Sep 2025 According to an Arcutis Biotherapeutics media release, company announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication of ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children down to the age of 2, supported by data from this study, as well as data from a long-term open-label study.
  • 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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