Clinical Trial

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)

Study acronym: Operetta III
Not Yet Recruiting Phase 2
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2026-03-25; most recent amendment 2026-06-30.
Trial Details
NCT Number NCT07503340
Lead Sponsor Hoffmann-La Roche
Conditions Relapsing-remitting Multiple Sclerosis
Enrollment 25 participants
Start Date 2026-08-01
Primary Completion 2029-08-01 (estimated)
Study Completion 2031-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-06