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: 15 Jun 2017
At a glance
- Drugs Etrolizumab (Primary) ; Adalimumab
- Indications Ulcerative colitis
- Focus Registrational; Therapeutic Use
- Acronyms HIBISUS II
- Sponsors Roche
- 04 May 2016 Planned End Date changed from 1 May 2018 to 1 Mar 2018.
- 04 May 2016 Planned primary completion date changed from 1 May 2018 to 1 Mar 2018.
- 31 Dec 2015 Planned End Date changed from 1 Mar 2018 to 1 May 2018 as per ClinicalTrials.gov record.