Summary

Eligibility
for people ages 10-18 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Ocrelizumab

Eligibility

You can join if…

Open to people ages 10-18

  • 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 baseline
  • 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

You CAN'T join if...

  • 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, tuberculosis)
  • Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment allocation
  • 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 situ
  • History of a severe allergic or anaphylactic reaction to humanized or murine monoclonal antibody (mAbs) or known hypersensitivity to any component of ocrelizumab solution
  • 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

Locations

  • University of California San Francisco not yet accepting patients
    San Francisco California 94117 United States
  • Loma Linda University health not yet accepting patients
    Loma Linda California 92354 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04075266
Phase
Phase 2
Study Type
Interventional
Last Updated