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A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis 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, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Sep 2023

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At a glance

  • Drugs Vedolizumab (Primary) ; Vedolizumab
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms VISIBLE 1
  • Sponsors Takeda; Takeda Development Centre Europe

    • Most Recent Events

    • 27 Sep 2023 According to an Takeda media release, based on results from this trial the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) administration of ENTYVIO(vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) after induction therapy with ENTYVIO intravenous (IV).
    • 09 May 2023 Results of post-hoc pooled analysis GEMINI 1, VARSITY, and VISIBLE 1 assessing advanced therapies in patients with UC stratified by ethnicity and race in order to identify differential efficacy and safety outcomes among the populations investigated, presented at the Digestive Disease Week 2023.
    • 09 May 2023 Results of studies LIBERTY-UC, NCT02883452, NOR-SWITCH and VISIBLE 1, GEMINI 1, VARSITY; comparing the discontinuation rates due to lack of efficacy between IFX and VDZ, presented at the Digestive Disease Week 2023
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