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New hope for kids with MS: major drug showdown begins

NCT ID NCT05123703

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Updated 2 times

Summary

This study tests whether ocrelizumab is safer and more effective than fingolimod for children and adolescents (ages 10 to under 18) with relapsing-remitting multiple sclerosis. Participants receive either drug and are monitored for relapses and brain lesions over at least 24 weeks. The goal is to find a better treatment option to control this chronic disease.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

188 people

The number who actually took part.

Started

May 2022

Expected to finish

Sep 2029

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: * Body weight ≥ 25 kg * Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric multiple sclerosis (MS), Version 2012, or McDonald criteria 2017 * Expanded Disability Status Scale (EDSS) at screening: 0-5.5, inclusive * For all countries except Germany, at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of at least one Gd-enhancing lesion on MRI within 6 months prior to randomization Inclusion Criteria for Optional OLE Period: -Participants in Group A (ocrelizumab in the DBP) and Group B (fingolimod in the DBP) who, in the opinion of the investigator, may benefit from switching to ocrelizumab and who have completed the DBP with study treatment (ocrelizumab/fingolimod), may participate in the OLE period Exclusion Criteria: * Known presence or suspicion of other neurologic disorders that may mimic MS * Significant uncontrolled somatic diseases, known active infection or any other significant condition that may preclude participant from participating in the study * Participants with severe cardiac disease or significant findings on the screening electrocardiograph (ECG) Exclusion Criteria for Optional OLE Period: -Participants who have discontinued the study during the DBP

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Conditions

The condition(s) this trial relates to.

relapsing-remitting multiple sclerosis

As listed by the trial registrant

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

Relapsing-remitting multiple sclerosis

Contacts and locations

Locations

  • Astra Kliinik

    Tallinn, 11315, Estonia

  • Azienda Ospedaliera Sant'Andrea

    Rome, Lazio, 00189, Italy

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Catania, Sicily, 95123, Italy

  • Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari

    Bari, Apulia, 70124, Italy

  • Baylor College of Medicine/Texas Children's Hospital

    Houston, Texas, 77030-2608, United States

  • Boston Children's Hospital Central Pharmacy

    Boston, Massachusetts, 02115-5724, United States

  • CHRU de Montpellier, Hopital Gui de Chauliac

    Montpellier, 34295, France

  • CHU Mohammed VI

    Marrakesh, 40000, Morocco

  • CPQuali Pesquisa Clínica Sao Paulo

    São Paulo, São Paulo, 01228-000, Brazil

  • Centre Hospitalier Universitaire de Bicêtre

    Le Kremlin-Bicêtre, 94275, France

  • Centro de Investigacion Clinica Chapultepec S. A. de C. V.

    Morelia, Michoacán, 58260, Mexico

  • Centro de Investigaciones Médicas Tucuman

    San Miguel de Tucumán, T4000AXL, Argentina

  • Children's Clinical University Hospital

    Riga, LV-1004, Latvia

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1, Canada

  • Children's National Hospital

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

  • Childrens University Hospital

    Belgrade, 11000, Serbia

  • Cleveland Clinic, Mellen Center for Multiple Sclerosis

    Cleveland, Ohio, 44195-0001, United States

  • Clinic for Neurology and Psychiatry for Children and Youth

    Belgrade, 11000, Serbia

  • Clinstile S.A de C.V.

    Mexico City, Mexico CITY (federal District), 06700, Mexico

  • Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

    Lviv, Kharkiv Governorate, 79010, Ukraine

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, H-4032, Hungary

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

    Warsaw, 02-091, Poland

  • Eginitio University General Hospital of Athens

    Athens, Attica, 115 28, Greece

  • FAICIC S de R.L. de C.V

    Veracruz, 91900, Mexico

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, Lombardy, 20133, Italy

  • Grupo Médico Camino S.C.

    Mexico City, Mexico CITY (federal District), 3310, Mexico

  • Hopital de Hautepierre

    Strasbourg, 67091, France

  • Hospices Civils de Lyon - Hôpital Pierre Wertheimer

    Bron, Rhône, 69003, France

  • Hospital Civil Fray Antonio Alcalde

    Guadalajara, Jalisco, 44280, Mexico

  • Hospital Sant Joan De Deu

    Esplugues de Llobregas, Barcelona, 08950, Spain

  • Hospital Santo Antonio dos Capuchos

    Lisbon, 1169-050, Portugal

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario de la Princesa

    Madrid, 28006, Spain

  • Hospital de Braga

    Braga, 4710-243, Portugal

  • Inst. Da Criança- Faculdade de Medicina Usp

    São Paulo, 05403-900, Brazil

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310, Brazil

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warsaw, 04-730, Poland

  • Johns Hopkins Medicine

    Baltimore, Maryland, 21287, United States

  • L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

    Brasília, Federal District, 70200-730, Brazil

  • Medizinische Universität Wien

    Vienna, 1090, Austria

  • Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

    Belgrade, 11000, Serbia

  • Neurociencias Estudios Clinicos S.C.

    Culiacán, Sinaloa, 80020, Mexico

  • Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR

    Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

  • Ospedale Pediatrico Bambino Gesù

    Rome, Lazio, 00165, Italy

  • Prof Dr Alexandru Obregia Clinical Psychiatric Hospital

    Bucharest, 041914, Romania

  • Royal Children's Hospital Melbourne - PIN

    Parkville, Victoria, 3052, Australia

  • Royal Hospital for Children and Young People

    Edinburgh, EH51, United Kingdom

  • Semmelweis Egyetem

    Budapest, 1094, Hungary

  • Sparsh Super Speciality Hospital

    Bangalore North, Karnataka, 560022, India

  • St. Luke's Hospital

    Thessaloniki, 552 36, Greece

  • Tartu University Hospital

    Tartu, 50406, Estonia

  • The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company

    Columbus, Ohio, 43235, United States

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104-4319, United States

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • UC San Diego

    La Jolla, California, 92037-1337, United States

  • ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra

    Coimbra, 3000-602, Portugal

  • UZ Gent

    Ghent, 9000, Belgium

  • Universita? G. D'Annunzio

    Chieti, Abruzzo, 66100, Italy

  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, 01307, Germany

  • University Clinical Centre of Nis

    Niš, 18000, Serbia

  • University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA

    Chaïdári, Attica, 124 62, Greece

  • Universitäts-Kinderspital Zürich - Eleonorenstiftung

    Zurich, 8008, Switzerland

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Późna, 60-355, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-952, Poland

  • Vestische Kinder- und Jugendklinik Datteln

    Datteln, 45711, Germany

  • Victor Gomoiu Clinical Hospital for Children

    Bucharest, 022102, Romania

  • Washington University

    St Louis, Missouri, 63101, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.