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Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors

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Trial Profile

Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Etrolizumab (Primary) ; Adalimumab
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms HIBISCUS I
  • Sponsors Roche

Most Recent Events

  • 13 Oct 2020 Results of pooled analysis of HIBISCUS I & II assessing safety and efficacy of etrolizumab as induction therapy for active ulcerative colitis compared with placebo and with adalimumab in patients naive to anti-tumor necrosis factor agents, presented at the 28th United European Gastroenterology Week.
  • 10 Aug 2020 According to a Roche media release, further analyses of the data, including secondary endpoints, are ongoing and will be submitted for presentation at upcoming medical meetings.
  • 10 Aug 2020 Primary endpoint (Percentage of Participants With Induction of Remission With Etrolizumab Compared With Placebo at Week 10, as Determined by the Mayo Clinic Score (MCS)), has been met, according to a roche media release.

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