Summary

for people ages 10-18 (full criteria)
at San Francisco, California and other locations
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 of other neurologic disorders that may mimic MS, including, but not limited to, acute disseminated encephalomyelitis, neuromyelitis optica or neuromyelitis optica spectrum disorders
  • 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
  • T-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
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04075266
Phase
Phase 2
Study Type
Interventional
Last Updated