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ACTIVE NOT RECRUITING
NCT05123703
PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

10 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

188

Start Date

2022-05-19

Completion Date

2029-09-17

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

DRUG

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.

OTHER

Ocrelizumab Placebo

Ocrelizumab matching placebo will be administered by IV infusion on Day 1 and Day 15 and Q24W thereafter.

DRUG

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).

OTHER

Fingolimod Placebo

Fingolimod matching placebo will be administered daily as a capsule.

Locations (102)

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

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

Addenbrookes Hospital

Cambridge, United Kingdom

Royal Hospital for Children and Young People

Edinburgh, United Kingdom

Great Ormond Street Hospital For Children

London, United Kingdom