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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: 03 Sep 2026

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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

  • 20 Aug 2026 Planned End Date changed from 5 Oct 2027 to 6 Oct 2027.
  • 28 May 2026 According to Johnson & Johnson media release, the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to include evidence in the TREMFYA (guselkumab) label for the inhibition of progression of structural joint damage in adults with active psoriatic arthritis (PsA).The label update is supported by 24 week results from the Phase 3b APEX study.
  • 04 Feb 2026 Planned End Date changed from 19 May 2028 to 5 Oct 2027.

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