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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 29 Nov 2017

At a glance

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

    • 23 Nov 2017 Planned End Date changed from 31 Mar 2018 to 30 Oct 2020.
    • 23 Nov 2017 Planned primary completion date changed from 31 Mar 2018 to 30 Oct 2020.
    • 04 May 2016 Planned End Date changed from 1 Nov 2018 to 1 Mar 2018.
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