A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS) (Operetta 2)

January 29, 2026 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad de Buenos Aires, Argentina, 1133
        • Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan
      • Córdoba, Argentina, X5000FHP
        • Clinica Universitaria Reina Fabiola
      • San Miguel de Tucumán, Argentina, T4000AXL
        • Centro de Investigaciones Medicas Tucuman
  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Royal Children's Hospital Melbourne - PIN
  • Austria
      • Vienna, Austria, 1090
        • Medizinische Universitat Wien
  • Belgium
      • Brussels, Belgium, 1020
        • Hôpital Universitaire des Enfants Reine Fabiola
      • Brussels, Belgium, 1200
        • Cliniques Universitaires St-Luc
      • Ghent, Belgium, 9000
        • UZ Gent
  • Brazil
      • São Paulo, Brazil, 05403-900
        • Inst. Da Criança- Faculdade de Medicina Usp
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
    • Paraná
      • Curitiba, Paraná, Brazil, 81210-310
        • Instituto de Neurologia de Curitiba
    • Rio Grande do Sul
      • Caxias do Sul, Rio Grande do Sul, Brazil, 95070-560
        • Universidade de Caxias do Sul - Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Hospital Sao Lucas - PUCRS
      • Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
        • Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clínica Sao Paulo
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z1
        • University of Alberta Hospital
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children
  • Estonia
      • Tallinn, Estonia, 11315
        • Astra Kliinik
      • Tartu, Estonia, 50406
        • Tartu University Hospital
  • France
      • Le Kremlin-Bicêtre, France, 94275
        • Centre Hospitalier Universitaire de Bicêtre
      • Montpellier, France, 34295
        • CHRU de Montpellier, Hopital Gui de Chauliac
      • Strasbourg, France, 67091
        • Hopital de Hautepierre
    • Rhône
      • Bron, Rhône, France, 69003
        • Hospices Civils de Lyon - Hôpital Pierre Wertheimer
  • Germany
      • Datteln, Germany, 45711
        • Vestische Kinder- und Jugendklinik Datteln
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus an der TU Dresden
      • Göttingen, Germany, 37075
        • Universitätsmedizin Göttingen Georg-August-Universität
      • Münster, Germany, 48129
        • Universitatsklinikum Munster
  • Greece
      • Thessaloniki, Greece, 552 36
        • St. Luke's Hospital
    • Attica
      • Athens, Attica, Greece, 115 28
        • Eginitio University General Hospital of Athens
      • Chaïdári, Attica, Greece, 124 62
        • University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
  • Hungary
      • Budapest, Hungary, 1094
        • Semmelweis Egyetem
      • Debrecen, Hungary, H-4032
        • Debreceni Egyetem Klinikai Kozpont
  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380054
        • Zydus Hospital
    • Haryana
      • Gurugram, Haryana, India, 122001
        • Artemis Hospital
    • Karnataka
      • Bangalore North, Karnataka, India, 560022
        • Sparsh Super Speciality Hospital
    • Kerala
      • Kochi, Kerala, India, 682001
        • Amrita Institute of Medical Sciences and Research Centre
    • Maharashtra
      • Pune, Maharashtra, India, 411004
        • Deenanath Mangeshkar Hospital & Research Centre
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • All India Institute of Medical Sciences (AIIMS)
      • New Delhi, National Capital Territory of Delhi, India, 110070
        • Fortis Flight Lieutenant Rajan Dhall Hospital
  • Italy
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66100
        • Universita? G. D'Annunzio
    • Apulia
      • Bari, Apulia, Italy, 70124
        • Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari
    • Friuli Venezia Giulia
      • Trieste, Friuli Venezia Giulia, Italy, 34137
        • IRCCS Materno Infantile Burlo Garofolo - INCIPIT - PIN
    • Lazio
      • Rome, Lazio, Italy, 00165
        • Ospedale Pediatrico Bambino Gesu
      • Rome, Lazio, Italy, 00189
        • Azienda Ospedaliera Sant'Andrea
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
    • Sicily
      • Catania, Sicily, Italy, 95123
        • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
  • Latvia
      • Riga, Latvia, LV-1004
        • Children's Clinical University Hospital
  • Mexico
      • Veracruz, Mexico, 91900
        • FAICIC S de R.L. de C.V
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Hospital Civil Fray Antonio Alcalde
    • Mexico CITY (federal District)
      • Mexico City, Mexico CITY (federal District), Mexico, 06700
        • Clinstile S.A de C.V.
      • Mexico City, Mexico CITY (federal District), Mexico, 3310
        • Grupo Medico Camino S.C.
    • Michoacán
      • Morelia, Michoacán, Mexico, 58260
        • Centro de Investigacion Clinica Chapultepec S. A. de C. V.
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64310
        • Iecsi S.C.
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80020
        • Neurociencias Estudios Clinicos S.C.
      • Culiacán, Sinaloa, Mexico, 80230
        • Centro para el Desarrollo de la Medicina y de Asistencia
  • Morocco
      • Fes, Morocco, 30000
        • Hassan II University Hospital
      • Marrakesh, Morocco, 40000
        • CHU Mohammed VI
      • Rabat, Morocco, 10100
        • Centre Hospitalier Ibn Sina CHIS - Hopital des Specialites
      • Rabat, Morocco, 10100
        • Hospital Militaire Dinstruction Mohammed V de Rabat
  • Poland
      • ?ód?, Poland, 93-338
        • Instytut Centrum Zdrowia Matki Polki
      • Gda?sk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Późna, Poland, 60-355
        • Uniwersytecki Szpital Kliniczny w Poznaniu
      • Warsaw, Poland, 04-730
        • Instytut Pomnik Centrum Zdrowia Dziecka
      • Warsaw, Poland, 02-091
        • Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Coimbra, Portugal, 3000-602
        • ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
      • Lisbon, Portugal, 1169-050
        • Hospital Santo Antonio dos Capuchos
      • Lisbon, Portugal, 1649-035
        • Centro Hospitalar Lisboa Norte, E.P.E. ? Hospital de Santa Maria
  • Romania
      • Bucharest, Romania, 022102
        • Victor Gomoiu Clinical Hospital for Children
      • Bucharest, Romania, 041914
        • Prof Dr Alexandru Obregia Clinical Psychiatric Hospital
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinic for Neurology and Psychiatry for Children and Youth
      • Belgrade, Serbia, 11000
        • Childrens University Hospital
      • Belgrade, Serbia, 11000
        • Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
      • Niš, Serbia, 18000
        • University Clinical Centre of Nis
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28006
        • Hospital Universitario de la Princesa
      • Málaga, Spain, 29010
        • Hospital Regional Universitario Carlos Haya
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
    • Barcelona
      • Esplugues de Llobregas, Barcelona, Spain, 08950
        • Hospital Sant Joan de Déu
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Hospital de Cruces
  • Switzerland
      • Zurich, Switzerland, 8008
        • Universitäts-Kinderspital Zürich - Eleonorenstiftung
  • Ukraine
    • KIEV Governorate
      • Kyiv, KIEV Governorate, Ukraine, 04209
        • Ukrainian medical rehabilitation center for children with organic lesions of the nervous system
    • Kharkiv Governorate
      • Lviv, Kharkiv Governorate, Ukraine, 79010
        • Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital
    • Tavria Okruha
      • Dnipropetrovsk, Tavria Okruha, Ukraine, 49100
        • KZ "Dnipropetrovska oblasna dytiacha klinichna likarnia" DOR
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital
      • Edinburgh, United Kingdom, EH51
        • Royal Hospital for Children and Young People
      • London, United Kingdom, WC1N 3JH
        • Great Ormond Street Hospital for Children
  • United States
    • California
      • La Jolla, California, United States, 92037-1337
        • UC San Diego
      • San Francisco, California, United States, 94117
        • University of California San Francisco
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Children's National Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02115-5724
        • Boston Children's Hospital Central Pharmacy
    • Missouri
      • St Louis, Missouri, United States, 63101
        • Washington University
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson Medical School
    • Ohio
      • Cleveland, Ohio, United States, 44195-0001
        • Cleveland Clinic, Mellen Center for Multiple Sclerosis
      • Columbus, Ohio, United States, 43235
        • The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia
    • Texas
      • Houston, Texas, United States, 77030-2608
        • Baylor College of Medicine/Texas Children's Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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: Fingolimod Placebo
Fingolimod matching placebo will be administered daily as a capsule.
Active Comparator: 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Annualized Relapse Rate (ARR)
Time Frame: Baseline up to approximately 4 years
Baseline up to approximately 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of New or Enlarging T2-hyperintense Lesions (T2 lesions) as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-blind Period
Time Frame: Baseline up to approximately 4 years
Baseline up to approximately 4 years
Number of New or Enlarging T2 Lesions by Week 96
Time Frame: Baseline up to Week 96
Baseline up to Week 96
ARR by Week 96
Time Frame: Baseline up to Week 96
Baseline up to Week 96
Number of T1 Gadolinium (Gd) Lesions at Week 12
Time Frame: 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)
Time Frame: Baseline up to approximately 8 years
Baseline up to approximately 8 years
Prevalence of Anti-drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study
Time Frame: Baseline up to approximately 8 years
Baseline up to approximately 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

PPD Development, LP

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2022

Primary Completion (Actual)

June 9, 2025

Study Completion (Estimated)

September 17, 2029

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (Actual)

November 17, 2021

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WN42086
  • 2020-004128-41 (EudraCT Number)
  • 2023-506516-40-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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