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A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Trial Profile

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2024

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At a glance

  • Drugs Vedolizumab (Primary) ; Vedolizumab
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms VISIBLE 2
  • Sponsors Takeda; Takeda Development Centre Europe
  • Most Recent Events

    • 01 Feb 2024 According to a Takeda media release, ENTYVIO U.S. FDA Approval Decision on Crohn's Disease Filing is Expected in early FY2024.
    • 17 Oct 2023 Results comparing discontinuation rates due to lack of efficacy during maintenance treatment with infliximab or vedolizumab in patients with Crohn'S Disease (NCT02883452, NOR-SWITCH, PLANETCD, and LIBERTY-CD) infliximab and two RCTs (GEMINI 2 and VISIBLE 2) on vedolizumab, presented at the 31st United European Gastroenterology Week.
    • 13 Sep 2023 According to a Takeda media release, the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for the investigational subcutaneous (SC) administration of ENTYVIO (vedolizumab) for maintenance therapy in adults with moderately to severely active Crohn's disease (CD) after induction therapy with ENTYVIO intravenous (IV), based on data from this trial.
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