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
- Diseases
- Multiple sclerosis
- 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
Sites (76)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Investigaciones Medicas Tucuman Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Active, not recruiting |
| Royal Children's Hospital Melbourne - PIN Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| L2 Ip Instituto de Pesquisas Clinicas Ltda ME Coordinator of this site? Confirm its status | Brasília | Brazil | Unknown status |
| Instituto de Neurologia de Curitiba Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Sao Lucas - PUCRS Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| CPQuali Pesquisa Clínica Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Inst. Da Criança- Faculdade de Medicina Usp Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Children'S Hospital Of Eastern Ontario Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Universitäts-Kinderspital Zürich - Eleonorenstiftung Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Vestische Kinder- und Jugendklinik Datteln Coordinator of this site? Confirm its status | Datteln | Germany | Active, not recruiting |
| Technische Universität Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Completed |
| Rigshospitalet Coordinator of this site? Confirm its status | Glostrup | Denmark | Completed |
| Clinic4U OÜ Coordinator of this site? Confirm its status | Tallinn | Estonia | Active, not recruiting |
| Tartu University Hospital Coordinator of this site? Confirm its status | Tartu | Estonia | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Sant Joan De Deu Barcelona Hospital Coordinator of this site? Confirm its status | Esplugues De Llobregat | Spain | Active, not recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Pierre Wertheimer Coordinator of this site? Confirm its status | Bron | France | Active, not recruiting |
| Bicetre Hospital Coordinator of this site? Confirm its status | Le Kremlin Bicetre Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Active, not recruiting |
| Royal Hospital for Children and Young People Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" Coordinator of this site? Confirm its status | Chaïdári | Greece | Active, not recruiting |
| St. Luke's Hospital S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Djecja bolnica Srebrnjak Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Completed |
| KBC Split Coordinator of this site? Confirm its status | Split | Croatia | Completed |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Active, not recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Active, not recruiting |
| Sparsh Super Speciality Hospital Coordinator of this site? Confirm its status | Bangalore North | India | Unknown status |
| University Hospital Consorziale Policlinico Coordinator of this site? Confirm its status | Bari | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Active, not recruiting |
| Università degli Studi "Gabriele d'Annunzio" - Center for Advanced Studies and Technology (CAST) Coordinator of this site? Confirm its status | Chieti | Italy | Active, not recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Sant Andre Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Bernu Kliniska Universitates Slimnica VSIA Coordinator of this site? Confirm its status | Riga | Latvia | Active, not recruiting |
| CHU Mohammed VI Coordinator of this site? Confirm its status | Marrakesh | Morocco | Unknown status |
| Neurociencias Estudios Clinicos S.C. Coordinator of this site? Confirm its status | Culiacán | Mexico | Unknown status |
| Hospital Civil Fray Antonio Alcalde Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Grupo Médico Camino S.C. Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Clinstile, S.A. de C.V. Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Centro de Investigacion Clinica Chapultepec S.A. de C.V. Coordinator of this site? Confirm its status | Morelia | Mexico | Unknown status |
| FAICIC S. de R.L. de C.V. Coordinator of this site? Confirm its status | Veracruz | Mexico | Unknown status |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Instytut Pomnik Centrum Zdrowia Dziecka Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Active, not recruiting |
| Unidade Local de Saúde de Coimbra, E.P.E. Coordinator of this site? Confirm its status | Coimbra | Portugal | Active, not recruiting |
| Unidade Local De Saude De Sao Jose E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Active, not recruiting |
| Spitalul Clinic de Copii "Dr. Victor Gomoiu" Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Mother and Child Health Care Institute of Serbia Dr Vukan Cupic Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Childrens University Hospital Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Clinic for Neurology and Psychiatry for Children and Youth Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| University Clinical Centre of Nis Coordinator of this site? Confirm its status | Niš | Serbia | Unknown status |
| Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital Coordinator of this site? Confirm its status | Lviv | Ukraine | Unknown status |
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Johns Hopkins Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Boston Children's Hospital Central Pharmacy Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cleveland Clinic, Mellen Center for Multiple Sclerosis Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Baylor College of Medicine/ Texas Children's Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| UC San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| The Children's Hospital Of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Children's National Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.