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An Open Label, 4-Week, Phase 2, Maximal Usage Pharmacokinetics and Safety Study of ARQ-151 Cream 0.3% Administered QD in Pediatric Subjects (Ages 6 to 11 Years Old) With Plaque Psoriasis

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Trial Profile

An Open Label, 4-Week, Phase 2, Maximal Usage Pharmacokinetics and Safety Study of ARQ-151 Cream 0.3% Administered QD in Pediatric Subjects (Ages 6 to 11 Years Old) With Plaque Psoriasis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 17 Dec 2023

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At a glance

  • Drugs Roflumilast (Primary)
  • Indications Plaque psoriasis
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Arcutis Biotherapeutics
  • Most Recent Events

    • 06 Oct 2023 According to an Arcutis Biotherapeutics media release, company announced that based on data from this study the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) to expand the indication of ZORYVE (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children ages 6 to 11 years.
    • 19 Dec 2022 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 the expanded indication of ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children ages 2 to 11. As with adults and adolescents, plaque psoriasis is the most common form of psoriasis in children 2 to 11 years of age, with very similar clinical features.
    • 13 Jan 2022 Status changed from recruiting to completed.
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