A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)
NCT ID: NCT05123703
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
188 participants
INTERVENTIONAL
2022-05-19
2029-09-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ocrelizumab
Participants will receive ocrelizumab by intravenous (IV) infusion every 24 weeks (Q24W). The first dose is given as dual infusions of half the dose of ocrelizumab on Days 1 and 15 and subsequent doses are given as single infusions of ocrelizumab Q24W. Participants will also receive a placebo of fingolimod administered as once a day (QD) capsule.
Ocrelizumab
Ocrelizumab 300 milligrams (mg) will be administered by IV infusion to participants who weigh \< 35 kilograms (kg) and ocrelizumab 600 mg IV will be administered to participants who weigh ≥ 35 kg on Days 1 and 15 (half the dose, 2 weeks apart) and Q24W thereafter.
Fingolimod Placebo
Fingolimod matching placebo will be administered daily as a capsule.
Fingolimod
Participants will receive fingolimod orally (PO) QD as per the prescribing information provided with fingolimod. Participants will also receive a placebo of ocrelizumab administered as IV infusion on Days 1 and 15, and Q24W thereafter.
Ocrelizumab Placebo
Ocrelizumab matching placebo will be administered by IV infusion on Day 1 and Day 15 and Q24W thereafter.
Fingolimod
Fingolimod will be administered daily as a capsule per the prescribing information (0.25 mg to participants who weigh ≤ 40 kg and 0.5 mg to participants who weigh \> 40 kg).
Interventions
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Ocrelizumab
Ocrelizumab 300 milligrams (mg) will be administered by IV infusion to participants who weigh \< 35 kilograms (kg) and ocrelizumab 600 mg IV will be administered to participants who weigh ≥ 35 kg on Days 1 and 15 (half the dose, 2 weeks apart) and Q24W thereafter.
Ocrelizumab Placebo
Ocrelizumab matching placebo will be administered by IV infusion on Day 1 and Day 15 and Q24W thereafter.
Fingolimod
Fingolimod will be administered daily as a capsule per the prescribing information (0.25 mg to participants who weigh ≤ 40 kg and 0.5 mg to participants who weigh \> 40 kg).
Fingolimod Placebo
Fingolimod matching placebo will be administered daily as a capsule.
Eligibility Criteria
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Inclusion Criteria
* 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
-Participants in Group A (ocrelizumab in the double-blind period \[DBP\]) 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
* 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)
-Participants who have discontinued the study during the DBP
10 Years
17 Years
ALL
No
Sponsors
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PPD Development, LP
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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UC San Diego
La Jolla, California, United States
University of California San Francisco
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's National Hospital
Washington D.C., District of Columbia, United States
Johns Hopkins Medicine
Baltimore, Maryland, United States
Boston Children's Hospital Central Pharmacy
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Cleveland Clinic, Mellen Center for Multiple Sclerosis
Cleveland, Ohio, United States
The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company
Columbus, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan
Ciudad de Buenos Aires, , Argentina
Clinica Universitaria Reina Fabiola
Córdoba, , Argentina
Centro de Investigaciones Médicas Tucuman
San Miguel de Tucumán, , Argentina
Royal Children's Hospital Melbourne - PIN
Parkville, Victoria, Australia
Medizinische Universität Wien
Vienna, , Austria
Hôpital Universitaire des Enfants Reine Fabiola
Brussels, , Belgium
Cliniques Universitaires St-Luc
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
Brasília, Federal District, Brazil
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil
Universidade de Caxias do Sul - Rio Grande do Sul
Caxias do Sul, Rio Grande do Sul, Brazil
Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
CPQuali Pesquisa Clínica Sao Paulo
São Paulo, São Paulo, Brazil
Inst. Da Criança- Faculdade de Medicina Usp
São Paulo, , Brazil
University of Alberta Hospital
Edmonton, Alberta, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Astra Kliinik
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
Bron, Rhône, France
Centre Hospitalier Universitaire de Bicêtre
Le Kremlin-Bicêtre, , France
CHRU de Montpellier, Hopital Gui de Chauliac
Montpellier, , France
Hopital de Hautepierre
Strasbourg, , France
Vestische Kinder- und Jugendklinik Datteln
Datteln, , Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
Dresden, , Germany
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, , Germany
Universitätsklinikum Münster
Münster, , Germany
Eginitio University General Hospital of Athens
Athens, Attica, Greece
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
Chaïdári, Attica, Greece
St. Luke's Hospital
Thessaloniki, , Greece
Semmelweis Egyetem
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Zydus Hospital
Ahmedabad, Gujarat, India
Artemis Hospital
Gurugram, Haryana, India
Sparsh Super Speciality Hospital
Bangalore North, Karnataka, India
Amrita Institute of Medical Sciences and Research Centre
Kochi, Kerala, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, India
All India Institute Of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, India
Fortis Flight Lieutenant Rajan Dhall Hospital
New Delhi, National Capital Territory of Delhi, India
Seth G.S Medical College K.E.M Hospital
Mumbai, , India
Universita? G. D'Annunzio
Chieti, Abruzzo, Italy
Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari
Bari, Apulia, Italy
IRCCS Materno Infantile Burlo Garofolo - INCIPIT - PIN
Trieste, Friuli Venezia Giulia, Italy
Ospedale Pediatrico Bambino Gesù
Rome, Lazio, Italy
Azienda Ospedaliera Sant'Andrea
Rome, Lazio, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, Sicily, Italy
Children's Clinical University Hospital
Riga, , Latvia
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Clinstile S.A de C.V.
Mexico City, Mexico CITY (federal District), Mexico
Grupo Médico Camino S.C.
Mexico City, Mexico CITY (federal District), Mexico
Centro de Investigacion Clinica Chapultepec S. A. de C. V.
Morelia, Michoacán, Mexico
Iecsi S.C.
Monterrey, Nuevo León, Mexico
Neurociencias Estudios Clinicos S.C.
Culiacán, Sinaloa, Mexico
Centro para el Desarrollo de la Medicina y de Asistencia
Culiacán, Sinaloa, Mexico
FAICIC S de R.L. de C.V
Veracruz, , Mexico
Hassan II University Hospital
Fes, , Morocco
CHU Mohammed VI
Marrakesh, , Morocco
Centre Hospitalier Ibn Sina CHIS - Hopital des Specialites
Rabat, , Morocco
Hospital Militaire Dinstruction Mohammed V de Rabat
Rabat, , Morocco
Instytut Centrum Zdrowia Matki Polki
?ód?, , Poland
Uniwersyteckie Centrum Kliniczne
Gda?sk, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Późna, , Poland
Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego
Warsaw, , Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, , Poland
Hospital de Braga
Braga, , Portugal
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
Coimbra, , Portugal
Hospital Santo Antonio dos Capuchos
Lisbon, , Portugal
Centro Hospitalar Lisboa Norte, E.P.E. ? Hospital de Santa Maria
Lisbon, , Portugal
Victor Gomoiu Clinical Hospital for Children
Bucharest, , Romania
Prof Dr Alexandru Obregia Clinical Psychiatric Hospital
Bucharest, , Romania
Childrens University Hospital
Belgrade, , Serbia
Clinic for Neurology and Psychiatry for Children and Youth
Belgrade, , Serbia
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade, , Serbia
University Clinical Centre of Nis
Niš, , Serbia
Hospital Sant Joan De Deu
Esplugues de Llobregas, Barcelona, Spain
Hospital de Cruces
Barakaldo, Vizcaya, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Regional Universitario Carlos Haya
Málaga, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Universitäts-Kinderspital Zürich - Eleonorenstiftung
Zurich, , Switzerland
Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital
Lviv, Kharkiv Governorate, Ukraine
Ukrainian medical rehabilitation center for children with organic lesions of the nervous system
Kyiv, KIEV Governorate, Ukraine
KZ "Dnipropetrovska oblasna dytiacha klinichna likarnia" DOR
Dnipropetrovsk, Tavria Okruha, Ukraine
State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine
Kharkiv, , Ukraine
Addenbrookes Hospital
Cambridge, , United Kingdom
Royal Hospital for Children and Young People
Edinburgh, , United Kingdom
Great Ormond Street Hospital For Children
London, , United Kingdom
Countries
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References
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Mar S, Valeriani M, Steinborn B, Schreiner T, Waubant E, Filippi M, Kotulska K, Mazurkiewicz-Beldzinska M, El Azzouzi B, Lin CJ, Shen YA, Kletzl H, Evershed J, Hogea A, Manlius C, Bonati U, Banwell B. Ocrelizumab dose selection for treatment of pediatric relapsing-remitting multiple sclerosis: results of the OPERETTA I study. J Neurol. 2025 Jan 15;272(2):137. doi: 10.1007/s00415-024-12879-z.
Other Identifiers
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2020-004128-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506516-40-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
WN42086
Identifier Type: -
Identifier Source: org_study_id