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Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the of Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis (CADMUS)

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Trial Profile

Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the of Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis (CADMUS)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Feb 2024

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At a glance

  • Drugs Ustekinumab (Primary)
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Acronyms CADMUS
  • Sponsors Janssen Research & Development

    • Most Recent Events

    • 28 Sep 2022 Results of pooled analysis of data from 3 studies (CADMUS, CADMUS Jr, Go-VIVA) describe extrapolation approaches used to support intravenous (IV) golimumab for polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA) and subcutaneous (SC) ustekinumab for jPsA published in the Pediatric Drugs
    • 01 Aug 2022 According to a Janssen Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has approved STELARA (ustekinumab) for the treatment of pediatric patients six years of age and older with active psoriatic arthritis (PsA).The FDA's approval was based on multiple phase 3 studies including (PSTELLAR, CADMUS, and CADMUS Jr) and adult patients with active PsA (PSUMMIT I and II).
    • 23 Sep 2020 Results of pooled analysis of data pooled from 4 studies ( CADMUS, CADMUS-JR, LOTUS and PEARL) extrapolating pharmacodynamic effects of Ustekinumab from Adults to Pediatrics, presented at the 2020 American College of Clinical Pharmacology Annual Meeting

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