New MS drug trial targets kids: could ocrelizumab slow relapses?
NCT ID NCT04075266
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Multiple sclerosis are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Under-the-Skin MS drug: can a shot replace an IV drip?
- Can a common antihistamine boost multiple sclerosis treatment?
- Can exercise rebuild muscle and balance in MS?
- Can diet ease the crushing fatigue of multiple sclerosis?
- One-Time CAR-T infusion tested against progressive MS
- Can PET scans reveal hidden brain inflammation in MS?