Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Examine the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Patients With Moderately or Severely Active Ulcerative Colitis
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 20 Sep 2017
At a glance
- Drugs Vedolizumab (Primary)
- Indications Ulcerative colitis
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Takeda
- 22 Aug 2017 According to a Takeda media release, based on the data from this and GEMINI I trial, 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).
- 07 Jul 2017 Planned End Date changed from 1 Dec 2019 to 12 Mar 2018.
- 07 Jul 2017 Planned primary completion date changed from 1 Apr 2018 to 12 Mar 2018.