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A Phase 3b, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis

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Trial Profile

A Phase 3b, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis

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 PSTELLAR
  • Sponsors Janssen Biotech
  • Most Recent Events

    • 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).
    • 09 Dec 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 23 Jul 2015 Planned End Date changed from 1 Jul 2015 to 1 Aug 2015 as reported by ClinicalTrials.gov.
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