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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: 17 Mar 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

  • 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.
  • 13 Dec 2024 According to an Eli Lilly and Company media release, Lilly has submitted marketing applications for Omvoh in Crohn's disease around the globe, including the U.S. and Japan. Decisions are expected from these regulatory authorities starting in the first half of 2025.

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