A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST)
Phase of Trial: Phase IV
Latest Information Update: 19 Jan 2018
At a glance
- Drugs Vedolizumab (Primary) ; Ciprofloxacin
- Indications Pouchitis
- Focus Therapeutic Use
- Acronyms EARNEST
- Sponsors Takeda
- 12 Jul 2017 Planned number of patients changed from 200 to 110.
- 08 Jun 2017 Planned End Date changed from 30 Sep 2019 to 9 Mar 2019.
- 08 Jun 2017 Planned primary completion date changed from 30 Sep 2019 to 9 Mar 2019.