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 IN PATIENTS WHO ARE NAIVE TO TNF INHIBITORS
Phase of Trial: Phase III
Latest Information Update: 17 May 2017
At a glance
- Drugs Etrolizumab (Primary) ; Adalimumab
- Indications Ulcerative colitis
- Focus Registrational; Therapeutic Use
- Acronyms HIBISCUS I
- Sponsors Roche
- 04 May 2016 Planned End Date changed from 1 Nov 2018 to 1 Mar 2018.
- 04 May 2016 Planned primary completion date changed from 1 Nov 2018 to 1 Mar 2018.
- 31 Dec 2015 Planned End Date changed from 1 Mar 2018 to 1 Nov 2018 as per ClinicalTrials.gov.record.