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A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis

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Trial Profile

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Nov 2023

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At a glance

  • Drugs Vedolizumab (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms GEMINI-I
  • Sponsors Millennium

Most Recent Events

  • 17 Oct 2023 Results of matching-adjusted indirect comparisons (MAIC) of the efficacy and safety of Upadacitinib vs Vedolizumab, Ustekinumab and Tofacitinib in the phase 3 maintenance studies U-ACHIEVE, GEMINI-1, UNIFI & OCTAVE Sustain, presented at the 31st United European Gastroenterology Week.
  • 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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