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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004128-41 | EudraCT Number | ||
| 2023-506516-40-00 | Registry Identifier | EU CT Number |
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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
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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.
This Phase III randomized, double-blind, double-dummy, multicenter study will evaluate the safety and efficacy of ocrelizumab administered by IV infusion every 24 weeks compared with fingolimod taken orally daily, in children and adolescents with RRMS aged between 10 and < 18 years. The study plans to enroll 171 participants in a 1:1 randomization (ocrelizumab:fingolimod), globally. This study consists of a double-blind, double dummy period in which participants will be treated with either active ocrelizumab or active fingolimod for a flexible duration. Participants who complete the double-blind period will be offered the possibility to enter an optional open-label extension (OLE) treatment period of at least 144 weeks with ocrelizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocrelizumab | Experimental | 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. |
|
| Fingolimod | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate (ARR) | Baseline up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of New or Enlarging T2-hyperintense Lesions (T2 lesions) as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-blind Period | Baseline up to approximately 4 years | |
| Number of New or Enlarging T2 Lesions by Week 96 | Baseline up to Week 96 |
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Inclusion Criteria:
Inclusion Criteria for Optional OLE Period:
-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:
Exclusion Criteria for Optional OLE Period:
-Participants who have discontinued the study during the DBP
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego | La Jolla | California | 92037-1337 | United States | ||
| University of California San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39812825 | Derived | 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. |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Ocrelizumab Placebo | Other | Ocrelizumab matching placebo will be administered by IV infusion on Day 1 and Day 15 and Q24W thereafter. |
|
| Fingolimod | Drug | 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 | Other | Fingolimod matching placebo will be administered daily as a capsule. |
|
| ARR by Week 96 | Baseline up to Week 96 |
| Number of T1 Gadolinium (Gd) Lesions at Week 12 | Week 12 |
| Incidence and Severity of Adverse Events (AEs), With Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) | Baseline up to approximately 8 years |
| Prevalence of Anti-drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study | Baseline up to approximately 8 years |
| San Francisco |
| California |
| 94117 |
| United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | United States |
| Johns Hopkins Medicine | Baltimore | Maryland | 21287 | United States |
| Boston Children's Hospital Central Pharmacy | Boston | Massachusetts | 02115-5724 | United States |
| Washington University | St Louis | Missouri | 63101 | United States |
| Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| Cleveland Clinic, Mellen Center for Multiple Sclerosis | Cleveland | Ohio | 44195-0001 | United States |
| The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company | Columbus | Ohio | 43235 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Baylor College of Medicine/Texas Children's Hospital | Houston | Texas | 77030-2608 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | United States |
| Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan | Ciudad de Buenos Aires | 1133 | Argentina |
| Clinica Universitaria Reina Fabiola | Córdoba | X5000FHP | Argentina |
| Centro de Investigaciones Médicas Tucuman | San Miguel de Tucumán | T4000AXL | Argentina |
| Royal Children's Hospital Melbourne - PIN | Parkville | Victoria | 3052 | Australia |
| Medizinische Universität Wien | Vienna | 1090 | Austria |
| Hôpital Universitaire des Enfants Reine Fabiola | Brussels | 1020 | Belgium |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME | Brasília | Federal District | 70200-730 | Brazil |
| Instituto de Neurologia de Curitiba | Curitiba | Paraná | 81210-310 | Brazil |
| Universidade de Caxias do Sul - Rio Grande do Sul | Caxias do Sul | Rio Grande do Sul | 95070-560 | Brazil |
| Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR | Porto Alegre | Rio Grande do Sul | 90430-001 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| CPQuali Pesquisa Clínica Sao Paulo | São Paulo | São Paulo | 01228-000 | Brazil |
| Inst. Da Criança- Faculdade de Medicina Usp | São Paulo | 05403-900 | Brazil |
| University of Alberta Hospital | Edmonton | Alberta | T6G 1Z1 | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Astra Kliinik | Tallinn | 11315 | Estonia |
| Tartu University Hospital | Tartu | 50406 | Estonia |
| Hospices Civils de Lyon - Hôpital Pierre Wertheimer | Bron | Rhône | 69003 | France |
| Centre Hospitalier Universitaire de Bicêtre | Le Kremlin-Bicêtre | 94275 | France |
| CHRU de Montpellier, Hopital Gui de Chauliac | Montpellier | 34295 | France |
| Hopital de Hautepierre | Strasbourg | 67091 | France |
| Vestische Kinder- und Jugendklinik Datteln | Datteln | 45711 | Germany |
| Universitaetsklinikum Carl Gustav Carus an der TU Dresden | Dresden | 01307 | Germany |
| Universitätsmedizin Göttingen Georg-August-Universität | Göttingen | 37075 | Germany |
| Universitätsklinikum Münster | Münster | 48129 | Germany |
| Eginitio University General Hospital of Athens | Athens | Attica | 115 28 | Greece |
| University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA | Chaïdári | Attica | 124 62 | Greece |
| St. Luke's Hospital | Thessaloniki | 552 36 | Greece |
| Semmelweis Egyetem | Budapest | 1094 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | H-4032 | Hungary |
| Zydus Hospital | Ahmedabad | Gujarat | 380054 | India |
| Artemis Hospital | Gurugram | Haryana | 122001 | India |
| Sparsh Super Speciality Hospital | Bangalore North | Karnataka | 560022 | India |
| Amrita Institute of Medical Sciences and Research Centre | Kochi | Kerala | 682001 | India |
| Deenanath Mangeshkar Hospital & Research Centre | Pune | Maharashtra | 411004 | India |
| All India Institute Of Medical Sciences (AIIMS) | New Delhi | National Capital Territory of Delhi | 110029 | India |
| Fortis Flight Lieutenant Rajan Dhall Hospital | New Delhi | National Capital Territory of Delhi | 110070 | India |
| Universita? G. D'Annunzio | Chieti | Abruzzo | 66100 | Italy |
| Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari | Bari | Apulia | 70124 | Italy |
| IRCCS Materno Infantile Burlo Garofolo - INCIPIT - PIN | Trieste | Friuli Venezia Giulia | 34137 | Italy |
| Ospedale Pediatrico Bambino Gesù | Rome | Lazio | 00165 | Italy |
| Azienda Ospedaliera Sant'Andrea | Rome | Lazio | 00189 | Italy |
| Fondazione IRCCS Istituto Neurologico Carlo Besta | Milan | Lombardy | 20133 | Italy |
| Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele | Catania | Sicily | 95123 | Italy |
| Children's Clinical University Hospital | Riga | LV-1004 | Latvia |
| Hospital Civil Fray Antonio Alcalde | Guadalajara | Jalisco | 44280 | Mexico |
| Clinstile S.A de C.V. | Mexico City | Mexico CITY (federal District) | 06700 | Mexico |
| Grupo Médico Camino S.C. | Mexico City | Mexico CITY (federal District) | 3310 | Mexico |
| Centro de Investigacion Clinica Chapultepec S. A. de C. V. | Morelia | Michoacán | 58260 | Mexico |
| Iecsi S.C. | Monterrey | Nuevo León | 64310 | Mexico |
| Neurociencias Estudios Clinicos S.C. | Culiacán | Sinaloa | 80020 | Mexico |
| Centro para el Desarrollo de la Medicina y de Asistencia | Culiacán | Sinaloa | 80230 | Mexico |
| FAICIC S de R.L. de C.V | Veracruz | 91900 | Mexico |
| Hassan II University Hospital | Fes | 30000 | Morocco |
| CHU Mohammed VI | Marrakesh | 40000 | Morocco |
| Centre Hospitalier Ibn Sina CHIS - Hopital des Specialites | Rabat | 10100 | Morocco |
| Hospital Militaire Dinstruction Mohammed V de Rabat | Rabat | 10100 | Morocco |
| Instytut Centrum Zdrowia Matki Polki | ?ód? | 93-338 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gda?sk | 80-952 | Poland |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Późna | 60-355 | Poland |
| Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego | Warsaw | 02-091 | Poland |
| Instytut Pomnik Centrum Zdrowia Dziecka | Warsaw | 04-730 | Poland |
| Hospital de Braga | Braga | 4710-243 | Portugal |
| ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra | Coimbra | 3000-602 | Portugal |
| Hospital Santo Antonio dos Capuchos | Lisbon | 1169-050 | Portugal |
| Centro Hospitalar Lisboa Norte, E.P.E. ? Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Victor Gomoiu Clinical Hospital for Children | Bucharest | 022102 | Romania |
| Prof Dr Alexandru Obregia Clinical Psychiatric Hospital | Bucharest | 041914 | Romania |
| Childrens University Hospital | Belgrade | 11000 | Serbia |
| Clinic for Neurology and Psychiatry for Children and Youth | Belgrade | 11000 | Serbia |
| Mother and Child Health Care Institute of Serbia Dr Vukan Cupic | Belgrade | 11000 | Serbia |
| University Clinical Centre of Nis | Niš | 18000 | Serbia |
| Hospital Sant Joan De Deu | Esplugues de Llobregas | Barcelona | 08950 | Spain |
| Hospital de Cruces | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario de la Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Regional Universitario Carlos Haya | Málaga | 29010 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Universitäts-Kinderspital Zürich - Eleonorenstiftung | Zurich | 8008 | Switzerland |
| Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital | Lviv | Kharkiv Governorate | 79010 | Ukraine |
| Ukrainian medical rehabilitation center for children with organic lesions of the nervous system | Kyiv | KIEV Governorate | 04209 | Ukraine |
| KZ "Dnipropetrovska oblasna dytiacha klinichna likarnia" DOR | Dnipropetrovsk | Tavria Okruha | 49100 | Ukraine |
| Addenbrookes Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Royal Hospital for Children and Young People | Edinburgh | EH51 | United Kingdom |
| Great Ormond Street Hospital For Children | London | WC1N 3JH | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 5, 2026 | Jun 30, 2026 | 46 |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C533411 | ocrelizumab |
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |
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