drugset / Trial / NCT04919252

Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease

NCT04919252

Phase 3 Unknown 60 enrolled Yonsei University
NaSingle-groupOpen-labelTreatment

Summary

If subjects voluntarily consent to participation in the study, those who are finally determined to be eligible for the study after whether all of the inclusion criteria and none of the exclusion criteria are met is checked will receive the study drug. Efficacy and safety will be evaluated at baseline, baseline, 2 weeks, 6 weeks, 14 weeks, 22 weeks, 30 weeks, 38 weeks, 46 weeks, and 54 weeks.

Timeline

Start
2021-06-01
Primary completion
2022-12-31
Completion
2023-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Vedolizumab Monoclonal antibody 300 mg Intravenous