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Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Subjects With Moderate or Severe Ulcerative Colitis

Trial Profile

Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Subjects With Moderate or Severe Ulcerative Colitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 May 2019

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At a glance

  • Drugs Vedolizumab (Primary)
  • Indications Ulcerative colitis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Takeda
  • Most Recent Events

    • 26 Mar 2018 Status changed from active, no longer recruiting to completed.
    • 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.
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