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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 Crohn's Disease

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 Crohn's Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jun 2019

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At a glance

  • Drugs Vedolizumab (Primary)
  • Indications Crohn's disease
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Takeda
  • Most Recent Events

    • 10 Jun 2019 Status changed from active, no longer recruiting to completed.
    • 22 May 2019 According to a Takeda media release, based on the data from GEMINI II, GEMINI III [NCT01224171] and CCT001(NCT02038920), the Ministry of Health, Labour and Welfare (MHLW) has approved Entyvio for the treatment of adult patients with moderately to severely active Crohn's disease (CD) in Japan.
    • 22 Apr 2019 Planned End Date changed from 21 Feb 2019 to 28 Jun 2019.
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