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A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting Radiographic Progression in Participants With Active Psoriatic Arthritis

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Trial Profile

A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting Radiographic Progression in Participants With Active Psoriatic Arthritis

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Dec 2025

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At a glance

  • Drugs Guselkumab (Primary)
  • Indications Plaque psoriasis; Psoriatic arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms APEX
  • Sponsors Janssen Research & Development; Janssen-Cilag

Most Recent Events

  • 17 Nov 2025 According to Johnson & Johnson media release, the recent results support Johnson & Johnson's recent submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval to include new evidence in the TREMFYA label for the inhibition of progression of structural damage in adults with active PsA.
  • 17 Nov 2025 According to Johnson & Johnson media release, 24 Week data from the APEX study was recently published in the Annals of the Rheumatic Diseases.
  • 17 Nov 2025 According to Johnson & Johnson media release, data from this study data were presented at the Inflammatory Skin Disease Summit (ISDS) 2025.

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