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NCT05123703Active, not recruitingPhase 3

A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)

A Phase III Multicenter, Randomized, Double-blind, Double-dummy Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis

Source: ClinicalTrials.gov · Last updated 15 Jul 2026

Brief summary (registry, in English)

This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with RRMS aged between 10 and \< 18 years over a flexible duration. The double-blind period will last until after the last participant randomized has completed 24 weeks.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
188 (actual)
First submitted
16 Nov 2021
Start date
19 May 2022
Primary completion date
9 Jun 2025
Lead sponsor
Hoffmann-La Roche
NCT number
NCT05123703
EU CT number
2023-506516-40-00
EudraCT number
2020-004128-41

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 188
  • From 19 May 2022 to the primary completion date, 9 Jun 2025
  • 76 sites in 29 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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)

Other

  • -Participants who have discontinued the study during the DBP

Who the study is looking for

  • 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
  • -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

Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (76)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro de Investigaciones Medicas Tucuman
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San Miguel de TucumánArgentinaUnknown status
Medical University of Vienna
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ViennaAustriaActive, not recruiting
Royal Children's Hospital Melbourne - PIN
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ParkvilleAustraliaUnknown status
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
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SofiaBulgariaCompleted
L2 Ip Instituto de Pesquisas Clinicas Ltda ME
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BrasíliaBrazilUnknown status
Instituto de Neurologia de Curitiba
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CuritibaBrazilUnknown status
Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR
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Porto AlegreBrazilUnknown status
Hospital Sao Lucas - PUCRS
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Porto AlegreBrazilUnknown status
CPQuali Pesquisa Clínica Sao Paulo
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São PauloBrazilUnknown status
Inst. Da Criança- Faculdade de Medicina Usp
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São PauloBrazilUnknown status
Children'S Hospital Of Eastern Ontario
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OttawaCanadaUnknown status
The Hospital for Sick Children
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TorontoCanadaUnknown status
Universitäts-Kinderspital Zürich - Eleonorenstiftung
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ZurichSwitzerlandUnknown status
Vestische Kinder- und Jugendklinik Datteln
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DattelnGermanyActive, not recruiting
Technische Universität Dresden
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DresdenGermanyActive, not recruiting
Aarhus Universitetshospital
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Aarhus NDenmarkCompleted
Rigshospitalet
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GlostrupDenmarkCompleted
Clinic4U OÜ
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TallinnEstoniaActive, not recruiting
Tartu University Hospital
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TartuEstoniaActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Sant Joan De Deu Barcelona Hospital
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Esplugues De LlobregatSpainActive, not recruiting
Hospital Universitario de la Princesa
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MadridSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Hospital Pierre Wertheimer
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BronFranceActive, not recruiting
Bicetre Hospital
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Le Kremlin Bicetre CedexFranceActive, not recruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceActive, not recruiting
Royal Hospital for Children and Young People
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EdinburghUnited KingdomUnknown status
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
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ChaïdáriGreeceActive, not recruiting
St. Luke's Hospital S.A.
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ThessalonikiGreeceActive, not recruiting
Djecja bolnica Srebrnjak
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Grad ZagrebCroatiaCompleted
KBC Split
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SplitCroatiaCompleted
Semmelweis University
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BudapestHungaryActive, not recruiting
University of Debrecen
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DebrecenHungaryActive, not recruiting
Sparsh Super Speciality Hospital
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Bangalore NorthIndiaUnknown status
University Hospital Consorziale Policlinico
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BariItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyActive, not recruiting
Università degli Studi "Gabriele d'Annunzio" - Center for Advanced Studies and Technology (CAST)
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ChietiItalyActive, not recruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyActive, not recruiting
Ospedale Pediatrico Bambino Gesù
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RomeItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Sant Andre
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RomeItalyActive, not recruiting
Bernu Kliniska Universitates Slimnica VSIA
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RigaLatviaActive, not recruiting
CHU Mohammed VI
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MarrakeshMoroccoUnknown status
Neurociencias Estudios Clinicos S.C.
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CuliacánMexicoUnknown status
Hospital Civil Fray Antonio Alcalde
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GuadalajaraMexicoUnknown status
Grupo Médico Camino S.C.
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Mexico CityMexicoUnknown status
Clinstile, S.A. de C.V.
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Mexico CityMexicoUnknown status
Centro de Investigacion Clinica Chapultepec S.A. de C.V.
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MoreliaMexicoUnknown status
FAICIC S. de R.L. de C.V.
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VeracruzMexicoUnknown status
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsCompleted
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandActive, not recruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
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WarsawPolandActive, not recruiting
Instytut Pomnik Centrum Zdrowia Dziecka
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WarsawPolandActive, not recruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalActive, not recruiting
Unidade Local de Saúde de Coimbra, E.P.E.
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CoimbraPortugalActive, not recruiting
Unidade Local De Saude De Sao Jose E.P.E.
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LisbonPortugalActive, not recruiting
Spitalul Clinic de Copii "Dr. Victor Gomoiu"
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BucharestRomaniaActive, not recruiting
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
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BucharestRomaniaActive, not recruiting
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
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BelgradeSerbiaUnknown status
Childrens University Hospital
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BelgradeSerbiaUnknown status
Clinic for Neurology and Psychiatry for Children and Youth
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BelgradeSerbiaUnknown status
University Clinical Centre of Nis
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NišSerbiaUnknown status
Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital
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LvivUkraineUnknown status
Children's Hospital Colorado
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AuroraUnited StatesUnknown status
Johns Hopkins Medicine
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BaltimoreUnited StatesUnknown status
Boston Children's Hospital Central Pharmacy
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BostonUnited StatesUnknown status
Cleveland Clinic, Mellen Center for Multiple Sclerosis
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ClevelandUnited StatesUnknown status
The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company
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ColumbusUnited StatesUnknown status
Baylor College of Medicine/ Texas Children's Hospital
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HoustonUnited StatesUnknown status
UC San Diego
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La JollaUnited StatesUnknown status
The Children's Hospital Of Philadelphia
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PhiladelphiaUnited StatesUnknown status
Washington University
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St LouisUnited StatesUnknown status
Children's National Hospital
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Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.