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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

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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: 19 Apr 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

  • 18 Apr 2024 According to a Takeda media release, based on this trial the U.S. Food and Drug Administration (FDA) has approved ENTYVIO (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohns disease (CD) after induction therapy with intravenous (IV) ENTYVIO.
  • 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.

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