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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)
Sponsor: Hoffmann-La Roche
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.
Official title: An Open-label Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis
Key Details
Gender
All
Age Range
10 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2026-08-01
Completion Date
2031-08-01
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Ocrelizumab co-formulated with rHuPH20
Ocrelizumab co-formulated with rHuPH20 will be administered as per the schedule specified in the arm.