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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

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

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 19 Feb 2019

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
  • Most Recent Events

    • 12 Feb 2019 Planned End Date changed from 23 Oct 2024 to 1 Feb 2025.
    • 04 Sep 2018 Planned primary completion date changed from 16 Aug 2022 to 3 Jun 2022.
    • 31 Aug 2018 Biomarkers information updated
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