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A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Ustekinumab, a Fully Human Anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNFalpha Agent(s)

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Trial Profile

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Ustekinumab, a Fully Human Anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNFalpha Agent(s)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Aug 2022

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At a glance

  • Drugs Ustekinumab (Primary)
  • Indications Psoriatic arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms PSUMMIT II
  • Sponsors Janssen Research & Development; Janssen-Cilag

    • 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 Nov 2021 Results of pooled analysis identifying joint and skin efficacy of guselkumab versus ustekinumab up to week 52, using pooled patient-level trial data from DISCOVER 1&2 and PSUMMIT 1&2 presented at the ACR Convergence 2021
    • 05 Jun 2021 Results of pooled analysis comparing efficacy of guselkumab arms of DISCOVER 1 & 2 were pooled with the data from the ustekinumab trials PSUMMIT 1 & 2, presented at the 22nd Annual Congress of the European League Against Rheumatism.
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