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)
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
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History