drugset / Trial / NCT03138655
Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active UC or CD.
Timeline
- Start
- 2017-11-08
- Primary completion
- 2020-03-31
- Completion
- 2020-05-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |