2025-524164-37-00RecruitingPhase 2
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
F. Hoffmann-La Roche AG7 sites in 3 countries9 target enrollmentStarted: August 3, 2026Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- F. Hoffmann-La Roche AG
- Enrollment
- 9
- Locations
- 7
Study Overview
Brief Summary
To evaluate the pharmacokinetic (PK) of ocrelizumab subcutaneous (SC) in children and adolescents with RRMS
Eligibility Criteria
- Ages
- 0 years to 17 years (0-17 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Body weight ≥ 25 kg
- •Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria
- •The 2024 McDonald criteria will also be accepted (Montalban et al 2025).
- •Must have received all childhood required vaccinations as per local/national recommendations for childhood vaccination against infectious diseases
- •Expanded Disability Status Scale (EDSS) score, 0-5.5, at screening
- •Agreement to adhere to the contraception requirements
- •Neurologic stability for at least 30 days prior to screening, and between screening and baseline
Exclusion Criteria
- •Any known presence or suspicion of other neurologic disorders that may mimic MS, including, but not limited to, acute disseminated encephalomyelitis (ADEM), neuromyelitis-optica or neuromyelitis-optica spectrum disorders and any neurologic, somatic, or metabolic condition that could interfere with brain function or normal cognitive or neurological development
- •Participants who are positive for aquaporin 4 (AQP4) or myelin oligodendrocyte glycoprotein (MOG) antibody are not eligible to participate in the study
- •Infection requiring hospitalization or treatment with IV anti-infective agents
- •History or known presence of recurrent or chronic infection (e.g., human immunodeficiency virus, syphilis, tuberculosis)
- •Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment allocation
- •⦁ Previous treatment with B-cell-targeted therapies ⦁ Percentage of CD4 < 30% ⦁ Absolute Neutrophil Count < 1.5x1000/microliter ⦁ Lymphocyte count below the lower limit of normal (LLN) for age- and sex-specific reference range
Arms & Interventions
Ocrevus, Ocrevus 920 mg solution for injection
Test
Intervention: Ocrevus 920 mg solution for injection (Drug)
Ocrevus, Ocrevus 920 mg solution for injection
Test
Intervention: Ocrevus (Drug)
Investigators
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
Study Sites (7)
Loading locations...
Similar Trials
Not yet recruiting
Phase 3
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)Relapsing-remitting Multiple SclerosisNCT07503340Hoffmann-La Roche25
Recruiting
Phase 2
A Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Participants with Multiple Sclerosis2024-517980-22-00F. Hoffmann-La Roche AG86
Recruiting
Phase 3
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis2023-505980-36-00F. Hoffmann-La Roche AG363
Recruiting
Phase 3
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis2023-506467-34-00F. Hoffmann-La Roche AG357
Recruiting
Phase 3
A study to learn if rozanolixizumab is safe, how it moves through the body, and if it works in children with myasthenia gravisGeneralized Myasthenia Gravis2022-502074-16-00UCB Biopharma7