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- Operetta III
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)
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Autoimmune Disorder -
Multiple Sclerosis (MS) -
Relapsing-Remitting Multiple Sclerosis (RRMS)
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Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Study Identifier
NCT07503340, BA45841, 2025-524164-37-00
Condition
Relapsing-remitting Multiple Sclerosis
Official Title
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
Study 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.
Eligibility Criteria
All
≥10 Years & ≤ 17 Years
No
Inclusion Criteria
- 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 Criteria
- Participants who are positive for aquaporin 4 (AQP4) or myelin oligodendrocyte glycoprotein (MOG) antibody are not eligible to participate in the study
- 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
- 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 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)
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com