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An Open-Label, Parallel-Group Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis


Brief Summary:

This 2-year study will evaluate the safety, tolerability, pharmacokinetics (PK), and
pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages >/= 10 to < 18 years with relapsing-remitting multiple sclerosis (RRMS). The first 24-week period will serve to determine the dose of ocrelizumab to be further investigated in the subsequent Phase III study in children and adolescents.


Inclusion Criteria:

– Body weight >/= 25 kg

– Children and adolescents must have received all childhood required vaccinations

– Female participants of childbearing potential must agree to either remain completely
abstinent or to use reliable means of contraception

– Diagnosis of relapsing-remitting multiple sclerosis (RRMS)

– Expanded Disability Status Scale (EDSS) at screening: 0-5.5, inclusive

– Neurologic stability for >/= 30 days prior to screening, and between screening and

– Participants naive to prior disease-modifying therapy (DMT)

– Participants who have had at least 6 contiguous months of DMT within the past 1 year
must have evidence of disease activity occurring after the full 6-month course of
treatment, that is, at least one relapse or >/= 1 Gd-enhancing lesion(s) on a
T1-weighted brain MRI

Exclusion Criteria:

– Known presence or suspicion of other neurologic disorders that may mimic MS,
including, but not limited to, acute disseminated encephalomyelitis, 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

– Patients that are aquaporin 4 positive and myelin oligodendrocyte glycoprotein (MOG)
antibody positive are not eligible to participate in the study.

– In case of an ADEM-like appearance of the first MS attack, a second attack with clear
MS-like features is required.

– Infection requiring hospitalization or treatment with IV anti-infective agents

– History or known presence of recurrent or chronic infection (e.g., HIV, syphilis,

– Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment

– History or laboratory evidence of coagulation disorders

– Peripheral venous access that precludes IV administration and venous blood sampling

– Inability to complete a magnetic resonance imaging (MRI) scan

– History of cancer, including solid tumors, hematologic malignancies, and carcinoma in

– History of a severe allergic or anaphylactic reaction to humanized or murine
monoclonal antibody (mAbs) or known hypersensitivity to any component of ocrelizumab

– 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


  • Loma Linda University health, Loma Linda, California, United States, 92354
  • University of California San Francisco, San Francisco, California, United States, 94117
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