A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Ef… (NCT07503340) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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)
25 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range10 Years – 17 Years
SexALL
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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
* Partic…
What they're measuring
1
Peak Concentration (Cmax) of Ocrelizumab After the First SC Injection
Timeframe: Up to 24 weeks
2
Area Under the Concentration-time Curve Over a Dosing Interval (AUCtau) After the First SC Injection of Ocrelizumab
Timeframe: Up to 24 weeks
Trial details
NCT IDNCT07503340
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2029-08-01
Contact for this trial
Reference Study ID Number: BA45841 https://forpatients.roche.com/