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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jul 2018

At a glance

  • Drugs Vedolizumab (Primary)
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms GEMINI-III
  • Sponsors Millennium
  • Most Recent Events

    • 18 Jul 2018 According to a Takeda media release, based on the data from GEMINI II, GEMINI III [700060538] and CCT001(700240592) company has submitted an Application to the Ministry of Health, Labour and Welfare (MHLW) in Japan for the investigational humanized monoclonal antibody Entyvio for the treatment of adult patients with moderately to severely active Crohns disease (CD) in Japan.
    • 01 Jul 2018 According to a Takeda media release, Takeda received a New Drug Application Approval for Entyvio from the MHLW for the treatment of adults with moderate to severely active ulcerative colitis (UC).
    • 29 May 2018 Results validating a clinical prediction model (data collected from GEMINI-I and GEMINI-II trials) published in the Gastroenterology
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