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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: 12 Jul 2024

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At a glance

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

Most Recent Events

  • 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
  • 14 May 2024 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) for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children ages 6 years and older, based on the positive results of INTEGUMENT-1, INTEGUMENT-2, INTEGUMENT-PED, NCT03764475 & NCT04279119 studies.
  • 24 Nov 2022 Results assessing the pharmacokinetic profile of roflumilast delivered topically from a phase I maximal usage study and data from phase II and phase III studies (NCT04279119, NCT03392168, NCT04211363, NCT04211389), published in the American Journal of Clinical Dermatology.

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