Active — Not RecruitingPhase 2

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

United States, Italy, Poland23 participantsStarted 2020-01-09

Plain-language summary

This 2-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.

Who can participate

Age range

10 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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 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 hospit…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose Exploration Period: Area Under the Concentration Versus Time Curve of Ocrelizumab

Timeframe: Pre-dose 5- 30 minutes and post-dose 30 mins on Days 1, 15 and 169; At any time on Days 29, 57, 85 and 113

Dose Exploration Period: Maximum Concentration (Cmax) of Ocrelizumab

Timeframe: Pre-dose 5- 30 minutes and post-dose 30 mins on Days 1, 15 and 169; At any time on Days 29, 57, 85 and 113

Dose Exploration Period: Levels of CD 19+ B-cell Count in Blood

Timeframe: At Week 24

Trial details

NCT IDNCT04075266

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-05

Results submitted2024-10-16

View on ClinicalTrials.gov More Multiple Sclerosis trials

Plain-language summary

Who can participate

Age range

10 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Dose Exploration Period: Area Under the Concentration Versus Time Curve of Ocrelizumab

Timeframe: Pre-dose 5- 30 minutes and post-dose 30 mins on Days 1, 15 and 169; At any time on Days 29, 57, 85 and 113

Dose Exploration Period: Maximum Concentration (Cmax) of Ocrelizumab

Timeframe: Pre-dose 5- 30 minutes and post-dose 30 mins on Days 1, 15 and 169; At any time on Days 29, 57, 85 and 113

Dose Exploration Period: Levels of CD 19+ B-cell Count in Blood

Timeframe: At Week 24