Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis
Status:
Completed
Trial end date:
2020-10-16
Target enrollment:
Participant gender:
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 subjects 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.