2상모집 예정
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)
연구 개요
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.
- 스폰서
- 리드: 로슈
- 적응증
- Relapsing-remitting Multiple Sclerosis
- 중재
- Ocrelizumab co-formulated with rHuPH20
- 목표 등록
- 25명
- 시작일
- 2026-08-01
- 완료(예정)
- 2031-08-01
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