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)

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

For participants who are under 18 years old at the end of the OOE period, it may be extended until the participant turns 18 years old (or as required per local regulation) or until commercial ocrelizumab intravenous (IV) is approved for children and adolescents and available in the country for these participants, whichever occurs first.

Conditions

• Relapsing-remitting Multiple Sclerosis

Interventions

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

Timeline

• Start date: 2026-08-01
• Primary completion: 2029-08-01
• Completion: 2031-08-01
• First posted: 2026-03-31
• Last updated: 2026-03-31

Regulatory

• FDA-regulated drug study