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Clinical Trials in the USA / NCT04075266
Active, not recruiting Phase 2

A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis

NCT04075266 · tracked via the Priya Life Science USA tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2020-01-09
Last updated
2026-09-14

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

Ocrelizumab

Ocrelizumab: Ocrelizumab is administered as two infusions of half the dose given 14 days apart for the first dose, then subsequent doses are administered as a single infusion every 24 weeks. Cohort 1: total dose of 300 mg Cohort 2: total dose of 600 mg Cohort 3 and 4: additional dose level(s) may be lower than 300 mg, between 300 mg and 600 mg, or higher than 600 mg, but will be no higher than 1200 mg

Study summary

This 12-year study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18 years with relapsing-remitting multiple sclerosis (RRMS). The data from this study will serve to determine the dosing regimen of ocrelizumab to be further investigated in the subsequent Phase III study in children and adolescents.

Eligibility

Sex
ALL
Min age
10 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Age at screening between =/\>10 to \<18 years * 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 * 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 acute disseminated encephalomyelitis (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

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
University of Colorado Denver Childrens Hospital Rocky Mountain MS Center Aurora Colorado
Childrens National Health Center Washington D.C. District of Columbia
Boston Childrens Hospital Boston Massachusetts
Washington Universtiy school of Medicine St Louis Missouri
Cleveland Clinic Cleveland Ohio
Ospedale Pediatrico Bambino Gesù Rome Lazio
Azienda Ospedaliera Sant'Andrea Rome Lazio
AOU Policlinico V. Emanuele - P.O G. Rodolico Catania Sicily
Uniwersyteckie Centrum Kliniczne Gda?sk Poland
Uniwersytecki Szpital Kliniczny w Poznaniu Późna Poland
Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego Warsaw Poland
Instytut Pomnik Centrum Zdrowia Dziecka Warsaw Poland
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04075266 on ClinicalTrials.gov ↗ ← All trials in the USA