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A Phase 3 Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Subjects Greater Than or Equal to 6 to Less Than 12 Years of Age

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Trial Profile

A Phase 3 Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Subjects Greater Than or Equal to 6 to Less Than 12 Years of Age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Feb 2024

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At a glance

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

    • 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 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).
    • 31 Oct 2020 The trial has been completed in Belgium, according to European Clinical Trials Database record.
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