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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

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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2019

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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

    • 04 Nov 2019 Planned End Date changed from 29 Dec 2020 to 1 Jul 2020.
    • 04 Nov 2019 Planned primary completion date changed from 6 Oct 2020 to 11 Mar 2020.
    • 09 Aug 2019 Planned primary completion date changed from 29 Dec 2020 to 6 Oct 2020.
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