drugset / Trial / NCT04643483
A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of the study is to assess efficacy, safety and tolerability of 2 dose regimens of certolizumab pegol
Timeline
- Start
- 2021-06
- Primary completion
- 2023-09
- Completion
- 2026-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | 20 mg | Subcutaneous |
| Comparator | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Subject | Certolizumab Pegol | Protein / enzyme biologic | 100 mg | Subcutaneous |
| Subject | Certolizumab Pegol | Protein / enzyme biologic | 200 mg | Subcutaneous |
| Subject | Certolizumab Pegol | Protein / enzyme biologic | 300 mg | Subcutaneous |