A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Interventions
- Registration Number
- NCT05123703
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 171
- Body weight ≥ 25 kilograms (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
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ocrelizumab 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 Fingolimod Placebo 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 Ocrelizumab Placebo 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. Fingolimod 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.
- Primary Outcome Measures
Name Time Method Annualized Relapse Rate (ARR) Baseline up to approximately 4 years
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (106)
Centro de Investigaciones Médicas Tucuman
🇦🇷San Miguel de Tucuman, Argentina
Centre Hospitalier Universitaire de Bicêtre
🇫🇷Le Kremlin-bicêtre, France
Universita? G. D'Annunzio
🇮🇹Chieti, Abruzzo, Italy
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, District of Columbia, United States
Johns Hopkins Medicine
🇺🇸Baltimore, Maryland, United States
Pediatric Multiple Sclerosis and Related Disorders Program at Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Washington University, Pediatric MS and other Demyelinating Disease Center
🇺🇸Saint 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 MS
🇺🇸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
🇦🇷Cordoba, Argentina
Royal Children's Hospital Melbourne - PIN
🇦🇺Parkville, Victoria, Australia
Medizinische Universität Wien
🇦🇹Wien, Austria
Hôpital Universitaire des Enfants Reine Fabiola
🇧🇪Brussel, Belgium
Cliniques Universitaires St-Luc
🇧🇪Bruxelles, Belgium
UZ Gent
🇧🇪Gent, Belgium
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
🇧🇷Brasilia, Distrito Federal, 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
🇧🇷Sao 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
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
🇩🇪Muenster, Germany
Eginitio University General Hospital of Athens
🇬🇷Athina, Attiki, Greece
Attikon University General Hospital
🇬🇷Ahens, Greece
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Agios Loucas Clinic SA
🇬🇷Thessaloniki, Greece
Fortis Flight Lieutenant Rajan Dhall Hospital
🇮🇳New Delhi, Delhi, India
Zydus Hospital
🇮🇳Ahmadabad CITY, Gujarat, India
Artemis Hospital
🇮🇳Gurugram, Haryana, India
Debreceni Egyetem Klinikai Központ
🇭🇺Debrecen, Hungary
All India Institute Of Medical Sciences (AIIMS)
🇮🇳New Delhi, Delhi, 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 City, Maharashtra, India
Seth G.S Medical College K.E.M Hospital
🇮🇳Mumbai, India
IRCCS Materno Infantile Burlo Garofolo - INCIPIT - PIN
🇮🇹Trieste, Friuli-Venezia Giulia, Italy
Ospedale Pediatrico Bambino Gesù
🇮🇹Roma, Lazio, Italy
Azienda Ospedaliera Sant'Andrea
🇮🇹Roma, Lazio, Italy
Irccs A.O.U.San Martino Ist
🇮🇹Genova, Liguria, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
🇮🇹Milano, Lombardia, Italy
Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari
🇮🇹Bari, Puglia, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
🇮🇹Catania, Sicilia, 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, Michoacan, Mexico
Iecsi S.C.
🇲🇽Monterrey, Nuevo LEON, Mexico
Centro para el Desarrollo de la Medicina y de Asistencia
🇲🇽Culiacán Rosales, Sinaloa, Mexico
Neurociencias Estudios Clinicos S.C.
🇲🇽Culiacán, Sinaloa, Mexico
FAICIC S de R.L. de C.V
🇲🇽Veracruz, Mexico
Hassan II University Hospital
🇲🇦FES, Morocco
CHU Mohammed VI
🇲🇦Marrakech, Morocco
Centre Hospitalier Ibn Sina CHIS - Hopital des Specialites
🇲🇦Rabat, Morocco
Hospital Militaire Dinstruction Mohammed V de Rabat
🇲🇦Rabat, Morocco
Erasmus MC
🇳🇱Rotterdam, Netherlands
Instytut Centrum Zdrowia Matki Polki
🇵🇱?ód?, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gda?sk, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
🇵🇱Pozna?, Poland
Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego
🇵🇱Warszawa, Poland
Instytut Pomnik Centrum Zdrowia Dziecka
🇵🇱Warszawa, Poland
Hospital de Braga
🇵🇹Braga, Portugal
Centro Hospitalar e Universitário de Coimbra E.P.E.
🇵🇹Coimbra, Portugal
Hospital Santo Antonio dos Capuchos
🇵🇹Lisboa, Portugal
Centro Hospitalar Lisboa Norte, E.P.E. ? Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Victor Gomoiu Clinical Hospital for Children
🇷🇴Bucuresti, Romania
Prof Dr Alexandru Obregia Clinical Psychiatric Hospital
🇷🇴Bucuresti, 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
🇷🇸NIS, 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
🇪🇸Malaga, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Universitäts-Kinderspital Zürich - Eleonorenstiftung
🇨🇭Zurich, Switzerland
State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine
🇺🇦Kharkiv, Kharkiv Governorate, Ukraine
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
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
Royal Hospital for Children and Young People
🇬🇧Edinburgh, United Kingdom
Great Ormond Street Hospital For Children
🇬🇧London, United Kingdom