drugset
drugset / Trial / NCT03196427

Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

NCT03196427 ↗

Phase 2 Completed 59 enrolled Takeda Takeda Development Center Americas, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.

Timeline

Start
2018-07-30
Primary completion
2025-04-03
Completion
2025-07-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Vedolizumab Monoclonal antibody 100 mg Intravenous
Subject Vedolizumab Monoclonal antibody 150 mg Intravenous
Subject Vedolizumab Monoclonal antibody 200 mg Intravenous
Subject Vedolizumab Monoclonal antibody 300 mg Intravenous

Indications

Crohn disease ulcerative colitis