drugset / Trial / NCT03478956
A Phase I Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients With Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn's Disease
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will evaluate pharmacokinetics, pharmacodynamics and safety of etrolizumab in pediatric patients of 4 to \<18 years of age with moderate to severe ulcerative colitis (UC) or with moderate to severe Crohn's disease (CD).
Timeline
- Start
- 2018-03-27
- Primary completion
- 2019-12-02
- Completion
- 2023-09-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Etrolizumab | Monoclonal antibody | 1.5 mg/kg | Subcutaneous |
| Subject | Etrolizumab | Monoclonal antibody | 3 mg/kg | Subcutaneous |