drugset / Trial / NCT05442567
A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.
Timeline
- Start
- 2023-05-16
- Primary completion
- 2033-02-07
- Completion
- 2033-02-07
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 |