drugset / Trial / 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)

NCT07503340

Phase 2 Not yet recruiting 25 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-08-01
Primary completion
2029-08-01
Completion
2031-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ocrelizumab Monoclonal antibody 480 mg Subcutaneous
Subject Ocrelizumab Monoclonal antibody 920 mg Subcutaneous