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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05123703
Other study ID # WN42086
Secondary ID 2020-004128-41
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 4, 2022
Est. completion date September 17, 2029

Study information

Verified date March 2024
Source Hoffmann-La Roche
Contact Reference Study ID Number: WN42086 https://forpatients.roche.com
Phone 888-662-6728 (U.S. and Canada)
Email global-roche-genentech-trials@gene.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with relapsing-remitting multiple sclerosis aged between 10 and < 18 years over a duration of at least 96 weeks.


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 Multiple Sclerosis aged between 10 and < 18 years. The study plans to enroll 233 patients in a 1:1 randomization (ocrelizumab:fingolimod), globally. This study consists of a double-blind, double dummy period in which patients will be treated with either active ocrelizumab or active fingolimod for at least 96 weeks. Patients who complete the double-blind period will be offered the possibility to enter an optional open-label extension treatment period of at least 144 weeks with ocrelizumab.


Recruitment information / eligibility

Status Recruiting
Enrollment 233
Est. completion date September 17, 2029
Est. primary completion date July 7, 2025
Accepts healthy volunteers No
Gender All
Age group 10 Years to 17 Years
Eligibility Inclusion Criteria: - Body weight = 50 kg - Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria 2017 - EDSS at screening: 0-5.5, inclusive - Neurologic stability for = 30 days prior to screening, and between screening and Day 1 - 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 Exclusion Criteria: - 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 patient from participating in the study - Patient with severe cardiac disease or significant findings on the screening ECG

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ocrelizumab
Ocrelizumab will be administered at a dose of 600 mg by IV infusion on Day 1 and Day 15 (half the dose, 2 weeks apart) and every 24 weeks thereafter.
Other:
Ocrelizumab Placebo
Ocrelizumab placebo will be administered by IV infusion on day 1 and Day 15 and every 24 weeks thereafter.
Drug:
Fingolimod
Fingolimod will be administered daily as 0.5 mg capsule.
Other:
Fingolimod Placebo
Fingolimod placebo will be administsred daily as a capsule.

Locations

Country Name City State
Argentina Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan Ciudad Autonoma Buenos Aires
Argentina Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY San Miguel
Australia Royal Children's Hospital Melbourne - PIN Parkville Victoria
Austria Medizinische Universität Wien; Univ.Klinik fuer Neurologie Wien
Belgium Hôpital Universitaire des Enfants Reine Fabiola; porte 10, batiment K Brussel
Belgium Cliniques Universitaires St-Luc Bruxelles
Belgium UZ Gent Gent
Brazil L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME Brasilia DF
Brazil Universidade de Caxias do Sul - Rio Grande do Sul Caxias do Sul RS
Brazil Instituto de Neurologia de Curitiba Curitiba PR
Brazil Hospital Sao Lucas - PUCRS Porto Alegre RS
Brazil Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR Porto Alegre RS
Brazil CPQuali Pesquisa Clínica Sao Paulo Sao Paulo SP
Brazil Inst. Da Criança- Faculdade de Medicina Usp; Unidade de Pneumologia Sao Paulo SP
Brazil Intituto PENSI Sao Paulo SP
Bulgaria Multiprofile Hospital For Active Treatment In Neurology And Psychiatry (MHATNP) ''St. Naum" Sofia
Canada University of Alberta Hospital Edmonton Alberta
Canada Children's Hospital of Eastern Ontario Ottawa Ontario
Croatia University Hospital of Split Split
Croatia Children's Hospital Srebrnjak Zagreb
Denmark Aarhus Universitetshospital Aarhus N
Denmark Rigshospitalet Glostrup; Neurologisk Klinik Glostrup
Estonia Astra Kliinik Tallinn
Estonia Tartu University Hospital Tartu
France Centre Hospitalier Universitaire de Bicêtre Le Kremlin-bicêtre
France Hopital Pierre Wertheimer - Hopital Neurologique; Service de neurologie Lyon
France CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie Montpellier
France Hopital de Hautepierre Strasbourg
Germany Vestische Kinder- und Jugendklinik Datteln Datteln
Germany Universitaetsklinikum Carl Gustav Carus an der TU Dresden Dresden
Germany Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Kinder-und Jugendmedizin_UMG Göttingen
Germany Universitätsklinikum Münster; Klinik für Kinder- und Jugendmedizin Muenster
Greece Hospital Eginition; First Department of Neurology Athens
Greece Attikon University General Hospital Chaidari
Greece Agios Loucas Clinic SA Panorama
Greece Hippokration General Hospital; First Department of Pediatrics Thessaloniki
Hungary Semmelweis Egyetem Budapest
Hungary Debreceni Egyetem Klinikai Központ; Gyermekklinika Debrecen
India Zydus Hospital; Department of Neuro Sciences Ahmadabad CITY Gujarat
India Sparsh Super Speciality Hospital Bangalore North Karnataka
India Artemis Hospital Gurugram Haryana
India All India Institute Of Medical Sciences (AIIMS) New Delhi Delhi
India Fortis Flight Lieutenant Rajan Dhall Hospital New Delhi Delhi
India Deenanath Mangeshkar Hospital & Research Centre Pune Maharashtra
Italy Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele Catania Sicilia
Italy Universita? G. D'Annunzio; Dipartimento di Neuroscienze, Imaging e Scienze Cliniche Chieti Abruzzo
Italy Irccs A.O.U.San Martino Ist; Dinogmi Genova Liguria
Italy IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla Milano Lombardia
Italy A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche Napoli Campania
Italy Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN Pisa Toscana
Italy A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS) Roma Lazio
Italy Ospedale Pediatrico Bambino Gesù; Divisione di Neurologia Roma Lazio
Italy IRCCS Materno Infantile Burlo Garofolo - INCIPIT - PIN Trieste Friuli-Venezia Giulia
Latvia Children's Clinical University Hospital Riga
Mexico Grupo Médico Camino S.C. Ciudad de México Mexico CITY (federal District)
Mexico Neurociencias Estudios Clinicos S.C. Culiacán Sinaloa
Mexico Centro para el Desarrollo de la Medicina y de Asistencia Culiacán Rosales Sinaloa
Mexico Instituto de Investigaciones Aplicadas a la Neurociencia A.C. Durango
Mexico Hospital Civil Fray Antonio Alcalde Guadalajara Jalisco
Mexico Clinstile S.A de C.V. Mexico City Mexico CITY (federal District)
Mexico Iecsi S.C. Monterrey
Mexico Centro de Investigacion Clinica Chapultepec S. A. de C. V. Morelia Michoacan
Mexico FAICIC S de R.L. de C.V; FAICIC Clinical Research Veracruz
Morocco Hassan II University Hospital Fez
Morocco Centre Hospitalier Ibn Sina CHIS - Hopital des Specialites Rabat
Morocco Hospital Militaire Dinstruction Mohammed V de Rabat Rabat
Netherlands Erasmus MC Rotterdam
Poland Instytut Centrum Zdrowia Matki Polki; Klinika Neurologii ?ód?
Poland Uniwersyteckie Centrum Kliniczne; Klinika Neurologii Rozwojowej Gda?sk
Poland Uniwersytecki Szpital Kliniczny w Poznaniu; Od. Kliniczny Neurologii Dzieci i M?odziezy Pozna?
Poland Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego; Klinika Neurologii Dzieciecej Warszawa
Poland Instytut Pomnik Centrum Zdrowia Dziecka; Klinika Neurologii i Epileptologii Warszawa
Portugal Hospital de Braga Braga
Portugal Centro Hospitalar e Universitário de Coimbra E.P.E.; Hospital Pediátrico Coimbra
Portugal Centro Hospitalar Lisboa Norte, E.P.E. ? Hospital de Santa Maria; Servicos Farmaceuticos Lisboa
Portugal Hospital Santo Antonio dos Capuchos; Servico de Neurologia Lisboa
Romania Prof Dr Alexandru Obregia Clinical Psychiatric Hospital Bucuresti
Romania Victor Gomoiu Clinical Hospital for Children Bucuresti
Serbia 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 Center Kragujevac; Clinic of neurology Kragujevac
Serbia University Clinical Centre of Nis; Clinic of neurology NIS
Serbia Clinical Centre of Vojvodina Nova Sad
Spain Hospital de Cruces; Servicio de Neurologia Barakaldo Vizcaya
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Hospital Sant Joan De Deu Esplugues De Llobregas Barcelona
Spain Hospital Universitario de la Princesa; Servicio de Neurologia Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain Hospital Regional Universitario Carlos Haya; Servicio de Neurologia Malaga
Spain Hospital Universitario Virgen Macarena; Servicio de Neurologia Sevilla
Switzerland Hôpitaux Universit. de Genève Méd.Neurologie; Unité de Neurologie pédiatrique Genève
Switzerland Kinderspital Zurich - Eleonorenstiftung Zürich
Ukraine KZ "Dnipropetrovska oblasna dytiacha klinichna likarnia" DOR Dnipropetrovsk Tavria Okruha
Ukraine Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital Lviv Kharkiv Governorate
United Kingdom Birmingham Children's Hospital Birmingham
United Kingdom Addenbrookes Hospital Cambridge
United Kingdom Royal Hospital for Children and Young People Edinburgh
United Kingdom Great Ormond Street Hospital For Children; Neurology London
United States University of Colorado Denver Childrens Hospital Rocky Mountain MS Center Aurora Colorado
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 University of Virginia Health System Charlottesville Virginia
United States Cleveland Clinic, Mellen Center for Multiple Sclerosis Cleveland Ohio
United States The Boster Center for MS Columbus Ohio
United States Baylor College of Medicine/Texas Children's Hospital Houston Texas
United States UC San Diego; ACTRI La Jolla California
United States Robert Wood Johnson Medical School New Brunswick New Jersey
United States NYU Langone Medical Center; Laura and Isaac Perlmutter Cancer Center New York New York
United States The Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Washington University, Pediatric MS and other Demyelinating Disease Center Saint Louis Missouri
United States University of California San Francisco San Francisco California
United States Children's National Hospital Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
Hoffmann-La Roche PPD

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Croatia,  Denmark,  Estonia,  France,  Germany,  Greece,  Hungary,  India,  Italy,  Latvia,  Mexico,  Morocco,  Netherlands,  Poland,  Portugal,  Romania,  Serbia,  Spain,  Switzerland,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Annualized relapse rate (ARR) Baseline up to approximately 4 years
Secondary Number of new or enlarging T2-hyperintense lesions (T2 lesions) as detected by brain MRI during the double-blind period Baseline up to approximately 4 years
Secondary Number of new or enlarging T2 lesions by Week 96 Baseline up to Week 96
Secondary Annualized relapse rate (ARR) by Week 96 Baseline up to Week 96
Secondary Number of T1 Gd lesions at Week 12 Week 12
Secondary Incidence and severity of adverse events, 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
Secondary Prevalence of ADAs at baseline and incidence of ADAs during the study Baseline up to approximately 8 years
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