Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis

Summary

The purpose of this study is to investigate the efficacy and safety of vedolizumab intravenous (IV) dose optimization on mucosal healing compared with the standard vedolizumab IV dosing regimen over a 30 week treatment period in participants with moderately to severely active ulcerative colitis (UC) and high vedolizumab clearance, based on a Week 5 predefined serum vedolizumab concentration threshold less than (\<) 50 microgram per milliliter (microg/mL) and who are Week 6 non-responders based on partial Mayo score.

Timeline

Start

2017-03-29

Primary completion

2020-10-16

Completion

2020-10-16

Outcome

Missed primary endpoint

registry analysis (other test); RTP: Standard Treatment Arm vs RTP: Dose Optimized Arm; p =0.401; Odds Ratio (OR) 0.6 (95% CI 0.2 to 1.8); Chi-squared NCT03029143 ↗

Publications

• Jairath V, Yarur A, Osterman MT, James A, Balma D, Mehrotra S, Yang L, Yajnik V, Qasim Khan RM. ENTERPRET: A Randomized Controlled Trial of Vedolizumab Dose Optimization in Patients With Ulcerative Colitis Who Have Early Nonresponse. Clin Gastroenterol Hepatol. 2024 May;22(5):1077-1086.e13. doi: 10.1016/j.cgh.2023.10.029. Epub 2023 Nov 10.

Drugs

Indications