drugset / Trial / NCT02790138
A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to compare the efficacy of vedolizumab intravenous (IV) and placebo in terms of the percentage of participants with chronic or recurrent pouchitis achieving clinically relevant remission.
Timeline
- Start
- 2016-10-12
- Primary completion
- 2020-06-11
- Completion
- 2021-02-02
Publications
- Jairath V, Feagan BG, Silverberg MS, Danese S, Gionchetti P, Lowenberg M, Bressler B, Ferrante M, Hart A, Lindner D, Escher A, Jones S, Shen B, Travis S. Mucosal Healing With Vedolizumab in Patients With Chronic Pouchitis: EARNEST, a Randomized, Double-Blind, Placebo-Controlled Trial. Clin Gastroenterol Hepatol. 2025 Feb;23(2):321-330.e3. doi: 10.1016/j.cgh.2024.06.037. Epub 2024 Jul 16.
- Travis S, Silverberg MS, Danese S, Gionchetti P, Lowenberg M, Jairath V, Feagan BG, Bressler B, Ferrante M, Hart A, Lindner D, Escher A, Jones S, Shen B; EARNEST Study Group. Vedolizumab for the Treatment of Chronic Pouchitis. N Engl J Med. 2023 Mar 30;388(13):1191-1200. doi: 10.1056/NEJMoa2208450.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vedolizumab | Monoclonal antibody | 300 mg | Intravenous |
| Comparator | Ciprofloxacin | Small molecule | 500 mg | Oral |