Clinical trial NCT05123703: A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: pediatric Multiple Sclerosis
pediatric MS
children MS
children Multiple Sclerosis
pediatric ocrelizumab
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2021-11-17
Enrollment: 171
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

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 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

Primary outcomes:
measure: Annualized Relapse Rate (ARR)
timeFrame: Baseline up to approximately 4 years
Secondary outcomes:
measure: Number of New or Enlarging T2-hyperintense Lesions (T2 lesions) as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-blind Period
timeFrame: Baseline up to approximately 4 years
measure: Number of New or Enlarging T2 Lesions by Week 96
timeFrame: Baseline up to Week 96
measure: ARR by Week 96
timeFrame: Baseline up to Week 96
measure: Number of T1 Gadolinium (Gd) Lesions at Week 12
timeFrame: Week 12
measure: 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)
timeFrame: Baseline up to approximately 8 years
measure: Prevalence of Anti-drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study
timeFrame: Baseline up to approximately 8 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
city: Boston
country: United States
facility: Pediatric Multiple Sclerosis and Related Disorders Program at Boston Children's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University, Pediatric MS and other Demyelinating Disease Center
state: Missouri
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
city: Cleveland
country: United States
facility: Cleveland Clinic, Mellen Center for Multiple Sclerosis
state: Ohio
city: Columbus
country: United States
facility: The Boster Center for MS
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine/Texas Children's Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Ciudad de Buenos Aires
country: Argentina
facility: Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan
city: Cordoba
country: Argentina
facility: Clinica Universitaria Reina Fabiola
city: San Miguel de Tucuman
country: Argentina
facility: Centro de Investigaciones Médicas Tucuman
city: Parkville
country: Australia
facility: Royal Children's Hospital Melbourne - PIN
state: Victoria
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Brussel
country: Belgium
facility: Hôpital Universitaire des Enfants Reine Fabiola
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Gent
country: Belgium
facility: UZ Gent
city: Brasilia
country: Brazil
facility: L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
state: Distrito Federal
city: Curitiba
country: Brazil
facility: Instituto de Neurologia de Curitiba
state: Paraná
city: Caxias do Sul
country: Brazil
facility: Universidade de Caxias do Sul - Rio Grande do Sul
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica Sao Paulo
state: São Paulo
city: São Paulo
country: Brazil
facility: Inst. Da Criança- Faculdade de Medicina Usp
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Tallinn
country: Estonia
facility: Astra Kliinik
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Bron
country: France
facility: Hospices Civils de Lyon - Hôpital Pierre Wertheimer
state: Rhône
city: Le Kremlin-bicêtre
country: France
facility: Centre Hospitalier Universitaire de Bicêtre
city: Montpellier
country: France
facility: CHRU de Montpellier, Hopital Gui de Chauliac
city: Strasbourg
country: France
facility: Hopital de Hautepierre
city: Datteln
country: Germany
facility: Vestische Kinder- und Jugendklinik Datteln
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen Georg-August-Universität
city: Muenster
country: Germany
facility: Universitätsklinikum Münster
city: Athina
country: Greece
facility: Eginitio University General Hospital of Athens
state: Attiki
city: Ahens
country: Greece
facility: Attikon University General Hospital
city: Thessaloniki
country: Greece
facility: Agios Loucas Clinic SA
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ
city: New Delhi
country: India
facility: All India Institute Of Medical Sciences (AIIMS)
state: Delhi
city: New Delhi
country: India
facility: Fortis Flight Lieutenant Rajan Dhall Hospital
state: Delhi
city: Ahmadabad CITY
country: India
facility: Zydus Hospital
state: Gujarat
city: Gurugram
country: India
facility: Artemis Hospital
state: Haryana
city: Bangalore North
country: India
facility: Sparsh Super Speciality Hospital
state: Karnataka
city: Kochi
country: India
facility: Amrita Institute of Medical Sciences and Research Centre
state: Kerala
city: Pune City
country: India
facility: Deenanath Mangeshkar Hospital & Research Centre
state: Maharashtra
city: Mumbai
country: India
facility: Seth G.S Medical College K.E.M Hospital
city: Chieti
country: Italy
facility: Universita? G. D'Annunzio
state: Abruzzo
city: Trieste
country: Italy
facility: IRCCS Materno Infantile Burlo Garofolo - INCIPIT - PIN
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
state: Lazio
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea
state: Lazio
city: Genova
country: Italy
facility: Irccs A.O.U.San Martino Ist
state: Liguria
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta
state: Lombardia
city: Bari
country: Italy
facility: Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari
state: Puglia
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
state: Sicilia
city: Riga
country: Latvia
facility: Children's Clinical University Hospital
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde
state: Jalisco
city: Mexico City
country: Mexico
facility: Clinstile S.A de C.V.
state: Mexico CITY (federal District)
city: Mexico City
country: Mexico
facility: Grupo Médico Camino S.C.
state: Mexico CITY (federal District)
city: Morelia
country: Mexico
facility: Centro de Investigacion Clinica Chapultepec S. A. de C. V.
state: Michoacan
city: Monterrey
country: Mexico
facility: Iecsi S.C.
state: Nuevo LEON
city: Culiacán Rosales
country: Mexico
facility: Centro para el Desarrollo de la Medicina y de Asistencia
state: Sinaloa
city: Culiacán
country: Mexico
facility: Neurociencias Estudios Clinicos S.C.
state: Sinaloa
city: Veracruz
country: Mexico
facility: FAICIC S de R.L. de C.V
city: FES
country: Morocco
facility: Hassan II University Hospital
city: Marrakech
country: Morocco
facility: CHU Mohammed VI
city: Rabat
country: Morocco
facility: Centre Hospitalier Ibn Sina CHIS - Hopital des Specialites
city: Rabat
country: Morocco
facility: Hospital Militaire Dinstruction Mohammed V de Rabat
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: ?ód?
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki
city: Gda?sk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Pozna?
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
city: Warszawa
country: Poland
facility: Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego
city: Warszawa
country: Poland
facility: Instytut Pomnik Centrum Zdrowia Dziecka
city: Braga
country: Portugal
facility: Hospital de Braga
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra E.P.E.
city: Lisboa
country: Portugal
facility: Hospital Santo Antonio dos Capuchos
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte, E.P.E. ? Hospital de Santa Maria
city: Bucuresti
country: Romania
facility: Victor Gomoiu Clinical Hospital for Children
city: Bucuresti
country: Romania
facility: Prof Dr Alexandru Obregia Clinical Psychiatric Hospital
city: Belgrade
country: Serbia
facility: Childrens University Hospital
city: Belgrade
country: Serbia
facility: Clinic for Neurology and Psychiatry for Children and Youth
city: Belgrade
country: Serbia
facility: Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
city: NIS
country: Serbia
facility: University Clinical Centre of Nis
city: Esplugues De Llobregas
country: Spain
facility: Hospital Sant Joan De Deu
state: Barcelona
city: Barakaldo
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Zurich
country: Switzerland
facility: Universitäts-Kinderspital Zürich - Eleonorenstiftung
city: Kharkiv
country: Ukraine
facility: State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine
state: Kharkiv Governorate
city: Lviv
country: Ukraine
facility: Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital
state: Kharkiv Governorate
city: Kyiv
country: Ukraine
facility: Ukrainian medical rehabilitation center for children with organic lesions of the nervous system
state: KIEV Governorate
city: Dnipropetrovsk
country: Ukraine
facility: KZ "Dnipropetrovska oblasna dytiacha klinichna likarnia" DOR
state: Tavria Okruha
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Children and Young People
city: London
country: United Kingdom
facility: Great Ormond Street Hospital For Children
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: