A Phase 3, Randomized, Placebo-controlled, Blinded, Multi-center Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis (C13006 Millennium) (IRB No. 081067)

Trial Profile

A Phase 3, Randomized, Placebo-controlled, Blinded, Multi-center Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis (C13006 Millennium) (IRB No. 081067)

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Oct 2017

At a glance

  • Drugs Vedolizumab (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms GEMINI-I
  • Sponsors Millennium
  • Most Recent Events

    • 16 Oct 2017 According to a Takeda media release, post-hoc analysis from this trial will be presented at the World Congress of Gastroenterology (WCOG) at ACG2017.
    • 22 Aug 2017 According to a Takeda media release, based on the data from this and another phase III trial (NCT02039505), the company has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare in Japan for vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (UC).
    • 08 May 2017 According to a Takeda Pharmaceutical media release, results of post-hoc analysis of GEMINI-1 and GEMINI-II presented at he 2017 Digestive Disease Week (DDW) annual scientific meeting.
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