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

Trial Profile

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
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top