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A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

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Trial Profile

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

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

Latest Information Update: 22 May 2024

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At a glance

  • Drugs Guselkumab (Primary) ; Guselkumab (Primary) ; Ustekinumab; Ustekinumab
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms GALAXI; GALAXI 1; GALAXI 2; GALAXI 3
  • Sponsors Janssen Research & Development; Janssen-Cilag; Johnson & Johnson Innovative Medicine
  • Most Recent Events

    • 21 May 2024 Primary endpoint has been met. (Phase 3: Clinical Response at Week 12 and Endoscopic Response at Week 48 for TREMFYA 200mg SC q4w versus ustekinumab)
    • 21 May 2024 Primary endpoint has not been met. (Phase 3: Clinical Response at Week 12 and Endoscopic Response at Week 48 for TREMFYA 100mg SC q4w versus ustekinumab)
    • 21 May 2024 Primary endpoint has not been met. (Phase 3: Clinical Response at Week 12 and Clinical Remission at Week 48 for TREMFYA 100mg SC q4w versus ustekinumab)
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