BridgeMD
A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic effects of Subcutaneous Ocrelizumab in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis
EU CTIS ID: 2025-524164-37-00
What this study is testing
To evaluate the pharmacokinetic (PK) of ocrelizumab subcutaneous (SC) in children and adolescents with RRMS
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 2017. 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.