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NOT YET RECRUITING
NCT07503340
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Ocrelizumab co-formulated with rHuPH20

Ocrelizumab co-formulated with rHuPH20 will be administered as per the schedule specified in the arm.