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New MS drug trial targets kids: could ocrelizumab slow relapses?

NCT ID NCT04075266

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This study tests the safety and dosing of ocrelizumab in 23 children and teens (ages 10–18) with relapsing-remitting multiple sclerosis over 2 years. The goal is to find the best dose for a future larger study. Participants receive the drug and are monitored for side effects and B-cell levels.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

23 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Apr 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AOU Policlinico V. Emanuele - P.O G. Rodolico

    Catania, Sicily, 95123, Italy

  • Azienda Ospedaliera Sant'Andrea

    Rome, Lazio, 00189, Italy

  • Boston Childrens Hospital

    Boston, Massachusetts, 02115, United States

  • Childrens National Health Center

    Washington D.C., District of Columbia, 20010, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego

    Warsaw, 02-091, Poland

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warsaw, 04-730, Poland

  • Ospedale Pediatrico Bambino Gesù

    Rome, Lazio, 00165, Italy

  • University of Colorado Denver Childrens Hospital Rocky Mountain MS Center

    Aurora, Colorado, 80045, United States

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Późna, 60-355, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-952, Poland

  • Washington Universtiy school of Medicine

    St Louis, Missouri, 63110, United States

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