Ocrelizumab given under the skin in children and teens with relapsing multiple sclerosis
Tests ocrelizumab given under the skin in children and teens with relapsing-remitting multiple sclerosis.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Gdansk, Poznan, and Warsaw, PolandSee the 3 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 17 years old?
Source: NCT07503340, who can take part
Where in Poland
- Uniwersyteckie Centrum KliniczneGdansk, PolandNot yet recruiting
- Uniwersytecki Szpital Kliniczny w PoznaniuPoznan, PolandNot yet recruiting
- Instytut Pomnik Centrum Zdrowia DzieckaWarsaw, PolandNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07503340EU 2025-524164-37-00
- Record updated
- 14 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Children and adolescents from 10 years to less than 18 years of age, at the time of baseline visit; 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 or 2024; Neurologic stability for at least 30 days prior to screening, and between screening and baseline; Expanded Disability Status Scale (EDSS) score, 0-5.5, at screening; Must have received all childhood required vaccinations as per local/national recommendations for childhood vaccination against infectious diseases.
Exclusion: Participants who are positive for aquaporin 4 (AQP4) or myelin oligodendrocyte glycoprotein (MOG) antibody are not eligible to participate in the study; Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to baseline visit or oral anti-infective agents within 2 weeks prior to baseline visit; Contraindications to mandatory premedications (i.e., corticosteroids and histamines), including closed-angle glaucoma for antihistamines; Participants who have previously received treatment with B cell-targeted therapies, including ocrelizumab; Any previous treatment with cyclophosphamide, alemtuzumab, anti-CD4, cladribine, mitoxantrone, daclizumab, laquinimod, total body irradiation, or bone marrow transplantation; Treatment with any investigational agent within 24 weeks of screening or 5 half-lives, whichever is longer (or longer if indicated by the PD action of the drug); Any known presence or suspicion of other neurologic disorders that may mimic multiple sclerosis (MS); History or known presence of recurrent or chronic infection (e.g., human immunodeficiency virus [HIV], syphilis, tuberculosis [TB]); Contraindications against SC injections or other conditions not suitable for SC injections, e.g., extremely thin SC fat layer; History of a severe allergic or anaphylactic reaction to humanized or murine monoclonal antibody or known hypersensitivity to any component of ocrelizumab solution.