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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)

NCT07503340

Not Yet RecruitingPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Relapsing-remitting Multiple Sclerosis

Interventions: Ocrelizumab co-formulated with rHuPH20

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 overview

Sex: ALL

Age: 10 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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)