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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jul 2025

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At a glance

  • Drugs Mirikizumab (Primary) ; Mirikizumab (Primary) ; Ustekinumab; Ustekinumab
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms VIVID-1
  • Sponsors Eli Lilly and Company

Most Recent Events

  • 15 Jul 2025 According to an Eli Lilly and Company Media Release, Health Canada has approved Omvoh for the treatement of adult patients with moderately to severely active Crohn's disease (CD) and also approved a new citrate-free formulation of Omvoh for subcutaneous injection for the existing UC indication, as well as the new CD indication. The authorization of Omvoh for CD was based on results from the VIVID-1 clinical study.
  • 01 Feb 2025 Results of analysis used Phase 3 study data from patients with moderately to severely active CD, for whom fatigue could be more severe published in the Quality of Life Research.
  • 21 Jan 2025 According to an Eli Lilly and Company media release, announced today that the U.S. FDA has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease in adults based on results from this trial.

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