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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Jan 2022

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At a glance

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

    • Most Recent Events

    • 19 Aug 2021 Results of an exploratory analysis assessing clinical efficacy in patients allocated to 300 mg intravenous vedolizumab for induction and maintenance phases published in the Journal of Gastroenterology and Hepatology
    • 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).

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