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A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

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Trial Profile

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Nov 2023

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At a glance

  • Drugs Vedolizumab (Primary)
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms GEMINI 2; GEMINI-II
  • Sponsors Millennium

Most Recent Events

  • 17 Oct 2023 Results comparing discontinuation rates due to lack of efficacy during maintenance treatment with infliximab or vedolizumab in patients with Crohn'S Disease (NCT02883452, NOR-SWITCH, PLANETCD, and LIBERTY-CD) infliximab and two RCTs (GEMINI 2 and VISIBLE 2) on vedolizumab, presented at the 31st United European Gastroenterology Week.
  • 23 May 2021 Results of post-hoc analysis presented at the Digestive Disease Week 2021.
  • 22 Dec 2019 Results, an analysis of the data from GEMINI-2 study,GETAID and VICTORY dataset assessing the role of clinical decision support tool (CDST) in predicting efficacy of vedolizumab in Crohn's disease, published in the Alimentary Pharmacology and Therapeutics

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