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A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis

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Trial Profile

A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Mar 2025

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At a glance

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

Most Recent Events

  • 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 deriving patient level data from the VARSITY and other study, confirming the drug specificity in prediction of endoscopic remission, and the impact of integrating the CDST into clinical practice, 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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