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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: 19 Aug 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

  • 29 Jul 2025 According to Johnson & Johnson media release, Additional data will be presented at future medical meetings.
  • 24 Jul 2025 According to Johnson & Johnson media release, Based on data from this trial ,the company have submitted supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval to include new evidence in the TREMFYA (guselkumab) label for the inhibition of progression of structural damage in adults with active psoriatic arthritis (PsA).
  • 22 Jun 2025 Planned End Date changed from 27 Nov 2027 to 12 Jul 2030.

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