A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis Clinical Trial

— Operetta 2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

• Verified date: June 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
• 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: 171
• 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 = 40 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

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	Clinica Universitaria Reina Fabiola	Cordoba
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
Canada	The Hospital for Sick Children	Toronto	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; Belgyogyaszati es Hematologiai Klinika	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	Amrita Institute of Medical Sciences and Research Centre	Kochi	Kerala
India	Seth G.S Medical College K.E.M Hospital	Mumbai	Maharashtra
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	CHU Mohammed VI	Marrakech
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 Rozwojowej i Epileptologii	?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	University of Chicago Medical Center	Chicago	Illinois
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