drugset / Trial / NCT07503340
A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)
NaSingle-groupOpen-labelTreatment
Summary
The main purpose of this study is to evaluate the pharmacokinetics (PK) of ocrelizumab administered subcutaneously (SC) in children and adolescents aged 10 to \<18 years with RRMS. The study consists of a 48-week treatment period, an Optional Ocrelizumab Extension (OOE) period of at least 48 weeks, and Safety Follow-up (SFU) for 104 weeks.
Timeline
- Start
- 2026-08-01
- Primary completion
- 2029-08-01
- Completion
- 2031-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ocrelizumab | Monoclonal antibody | 480 mg | Subcutaneous |
| Subject | Ocrelizumab | Monoclonal antibody | 920 mg | Subcutaneous |