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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)

Study acronym: Operetta III
StatusNot Yet Recruiting
PhasePhase 3
Started2026-10-30
View on ClinicalTrials.gov ↗

Amendment history

2026-09-01
Study Status, Study Design v5
Phase changed: Phase 2 → Phase 3
Start date2026-08-01→2026-10-30
2026-08-04
Study Status v4
Re-verified, no change to tracked fields
2026-06-30
Study Status, Contacts/Locations, References v3
2026-05-22
2 amendments v1-v2
2 re-verifications since 2026-04-23, no change to tracked fields
2026-03-25
Original filing
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.
Trial Details
NCT Number NCT07503340
Lead Sponsor Hoffmann-La Roche
Conditions Relapsing-remitting Multiple Sclerosis
Enrollment 25 participants
Start Date 2026-10-30
Primary Completion 2029-08-01 (estimated)
Study Completion 2031-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-03