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Lo studio clinico NCT05123703 (Operetta 2) per Sclerosi multipla recidivante-remittente è attivo, non in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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RocheA Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS) (Operetta 2)
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT05123703 (Operetta 2) è uno studio interventistico di Fase III volto a esaminare il trattamento per Sclerosi multipla recidivante-remittente, attualmente attivo, non in arruolamento. Avviato il 19 maggio 2022, prevede di arruolare 188 partecipanti. Sotto la guida di Roche, dovrebbe concludersi entro il 17 settembre 2029. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 22 settembre 2025.
Sommario breve
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.
Descrizione dettagliata
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.
Titolo ufficiale
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
Condizioni
Sclerosi multipla recidivante-remittentePubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- Operetta 2
- WN42086
- 2020-004128-41 (Numero EudraCT)
- 2023-506516-40-00 (Identificativo del registro) (EU CT Number)
Numero NCT
Data di inizio (effettiva)
2022-05-19
Ultimo aggiornamento pubblicato
2025-09-22
Data di completamento (stimata)
2029-09-17
Arruolamento (previsto)
188
Tipo di studio
Interventistico
FASE
Fase III
Stato
Attivo, non in arruolamento
Parole chiave
pediatric Multiple Sclerosis
pediatric MS
children MS
children Multiple Sclerosis
pediatric ocrelizumab
pediatric MS
children MS
children Multiple Sclerosis
pediatric ocrelizumab
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Quadruplo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleOcrelizumab 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. | 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. Fingolimod Placebo Fingolimod matching placebo will be administered daily as a capsule. |
Comparatore attivoFingolimod 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. | Ocrelizumab Placebo Ocrelizumab matching placebo will be administered by IV infusion on Day 1 and Day 15 and Q24W thereafter. 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). |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Annualized Relapse Rate (ARR) | Baseline up to approximately 4 years |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Number of New or Enlarging T2-hyperintense Lesions (T2 lesions) as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-blind Period | Baseline up to approximately 4 years | |
Number of New or Enlarging T2 Lesions by Week 96 | Baseline up to Week 96 | |
ARR by Week 96 | Baseline up to Week 96 | |
Number of T1 Gadolinium (Gd) Lesions at 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) | Baseline up to approximately 8 years | |
Prevalence of Anti-drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study | Baseline up to approximately 8 years |
Criteri di eleggibilità
Età idonea
Bambino
Età minima
10 Years
Sessi idonei
Tutti
- 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
- 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
PPD Development, LPNessun dato di contatto
105 Centri dello studio in 25 paesi
Abruzzo
Universita? G. D'Annunzio, Chieti, Abruzzo, 66100, Italy
Apulia
Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari, Bari, Apulia, 70124, Italy
Friuli Venezia Giulia
IRCCS Materno Infantile Burlo Garofolo - INCIPIT - PIN, Trieste, Friuli Venezia Giulia, 34137, Italy
Lazio
Ospedale Pediatrico Bambino Gesù, Rome, Lazio, 00165, Italy
Azienda Ospedaliera Sant'Andrea, Rome, Lazio, 00189, Italy
Liguria
Irccs A.O.U.San Martino Ist, Genoa, Liguria, 16132, Italy
Lombardy
Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Lombardy, 20133, Italy
Sicily
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele, Catania, Sicily, 95123, Italy
Universitäts-Kinderspital Zürich - Eleonorenstiftung, Zurich, 8008, Switzerland
California
UC San Diego, La Jolla, California, 92037-1337, United States
University of California San Francisco, San Francisco, California, 94117, United States
Colorado
Children's Hospital Colorado, Aurora, Colorado, 80045, United States
District of Columbia
Children's National Hospital, Washington D.C., District of Columbia, 20010, United States
Maryland
Johns Hopkins Medicine, Baltimore, Maryland, 21287, United States
Massachusetts
Pediatric Multiple Sclerosis and Related Disorders Program at Boston Children's Hospital, Boston, Massachusetts, 02115, United States
Missouri
Washington University, St Louis, Missouri, 63101, United States
New Jersey
Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08901, United States
Ohio
Cleveland Clinic, Mellen Center for Multiple Sclerosis, Cleveland, Ohio, 44195-0001, United States
The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company, Columbus, Ohio, 43235, United States
Pennsylvania
The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States
Texas
Baylor College of Medicine/Texas Children's Hospital, Houston, Texas, 77030-2608, United States
Virginia
University of Virginia Health System, Charlottesville, Virginia, 22903, United States
Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan, Ciudad de Buenos Aires, 1133, Argentina
Clinica Universitaria Reina Fabiola, Córdoba, X5000FHP, Argentina
Centro de Investigaciones Médicas Tucuman, San Miguel de Tucumán, T4000AXL, Argentina
Victoria
Royal Children's Hospital Melbourne - PIN, Parkville, Victoria, 3052, Australia
Medizinische Universität Wien, Vienna, 1090, Austria
Hôpital Universitaire des Enfants Reine Fabiola, Brussels, 1020, Belgium
Cliniques Universitaires St-Luc, Brussels, 1200, Belgium
UZ Gent, Ghent, 9000, Belgium
Federal District
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME, Brasília, Federal District, 70200-730, Brazil
Paraná
Instituto de Neurologia de Curitiba, Curitiba, Paraná, 81210-310, Brazil
Rio Grande do Sul
Universidade de Caxias do Sul - Rio Grande do Sul, Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil
Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR, Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
Hospital Sao Lucas - PUCRS, Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
São Paulo
CPQuali Pesquisa Clínica Sao Paulo, São Paulo, São Paulo, 01228-000, Brazil
Inst. Da Criança- Faculdade de Medicina Usp, São Paulo, 05403-900, Brazil
Alberta
University of Alberta Hospital, Edmonton, Alberta, T6G 1Z1, Canada
Ontario
Children's Hospital of Eastern Ontario, Ottawa, Ontario, K1H 8L1, Canada
The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada
Astra Kliinik, Tallinn, 11315, Estonia
Tartu University Hospital, Tartu, 50406, Estonia
Rhône
Hospices Civils de Lyon - Hôpital Pierre Wertheimer, Bron, Rhône, 69003, France
Centre Hospitalier Universitaire de Bicêtre, Le Kremlin-Bicêtre, 94275, France
CHRU de Montpellier, Hopital Gui de Chauliac, Montpellier, 34295, France
Hopital de Hautepierre, Strasbourg, 67091, France
Vestische Kinder- und Jugendklinik Datteln, Datteln, 45711, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden, Dresden, 01307, Germany
Universitätsmedizin Göttingen Georg-August-Universität, Göttingen, 37075, Germany
Universitätsklinikum Münster, Münster, 48129, Germany
Attica
Eginitio University General Hospital of Athens, Athens, Attica, 115 28, Greece
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA, Chaïdári, Attica, 124 62, Greece
St. Luke's Hospital, Thessaloniki, 552 36, Greece
Semmelweis Egyetem, Budapest, 1094, Hungary
Debreceni Egyetem Klinikai Kozpont, Debrecen, H-4032, Hungary
Gujarat
Zydus Hospital, Ahmedabad, Gujarat, 380054, India
Haryana
Artemis Hospital, Gurugram, Haryana, 122001, India
Karnataka
Sparsh Super Speciality Hospital, Bangalore North, Karnataka, 560022, India
Kerala
Amrita Institute of Medical Sciences and Research Centre, Kochi, Kerala, 682001, India
Maharashtra
Deenanath Mangeshkar Hospital & Research Centre, Pune, Maharashtra, 411004, India
National Capital Territory of Delhi
All India Institute Of Medical Sciences (AIIMS), New Delhi, National Capital Territory of Delhi, 110029, India
Fortis Flight Lieutenant Rajan Dhall Hospital, New Delhi, National Capital Territory of Delhi, 110070, India
Seth G.S Medical College K.E.M Hospital, Mumbai, 400012, India
Children's Clinical University Hospital, Riga, LV-1004, Latvia
Jalisco
Hospital Civil Fray Antonio Alcalde, Guadalajara, Jalisco, 44280, Mexico
Mexico CITY (federal District)
Clinstile S.A de C.V., Mexico City, Mexico CITY (federal District), 06700, Mexico
Grupo Médico Camino S.C., Mexico City, Mexico CITY (federal District), 3310, Mexico
Michoacán
Centro de Investigacion Clinica Chapultepec S. A. de C. V., Morelia, Michoacán, 58260, Mexico
Nuevo León
Iecsi S.C., Monterrey, Nuevo León, 64310, Mexico
Sinaloa
Neurociencias Estudios Clinicos S.C., Culiacán, Sinaloa, 80020, Mexico
Centro para el Desarrollo de la Medicina y de Asistencia, Culiacán, Sinaloa, 80230, Mexico
FAICIC S de R.L. de C.V, Veracruz, 91900, Mexico
Hassan II University Hospital, Fes, 30000, Morocco
CHU Mohammed VI, Marrakesh, 40000, Morocco
Centre Hospitalier Ibn Sina CHIS - Hopital des Specialites, Rabat, 10100, Morocco
Hospital Militaire Dinstruction Mohammed V de Rabat, Rabat, 10100, Morocco
Instytut Centrum Zdrowia Matki Polki, ?ód?, 93-338, Poland
Uniwersyteckie Centrum Kliniczne, Gda?sk, 80-952, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu, Późna, 60-355, Poland
Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego, Warsaw, 02-091, Poland
Instytut Pomnik Centrum Zdrowia Dziecka, Warsaw, 04-730, Poland
Hospital de Braga, Braga, 4710-243, Portugal
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra, Coimbra, 3000-602, Portugal
Hospital Santo Antonio dos Capuchos, Lisbon, 1169-050, Portugal
Centro Hospitalar Lisboa Norte, E.P.E. ? Hospital de Santa Maria, Lisbon, 1649-035, Portugal
Victor Gomoiu Clinical Hospital for Children, Bucharest, 022102, Romania
Prof Dr Alexandru Obregia Clinical Psychiatric Hospital, Bucharest, 041914, Romania
Childrens University Hospital, Belgrade, 11000, Serbia
Clinic for Neurology and Psychiatry for Children and Youth, Belgrade, 11000, Serbia
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic, Belgrade, 11000, Serbia
University Clinical Centre of Nis, Niš, 18000, Serbia
Barcelona
Hospital Sant Joan De Deu, Esplugues de Llobregas, Barcelona, 08950, Spain
Vizcaya
Hospital de Cruces, Barakaldo, Vizcaya, 48903, Spain
Hospital Universitari Vall d'Hebron, Barcelona, 08035, Spain
Hospital Universitario de la Princesa, Madrid, 28006, Spain
Hospital Universitario Ramon y Cajal, Madrid, 28034, Spain
Hospital Regional Universitario Carlos Haya, Málaga, 29010, Spain
Hospital Universitario Virgen Macarena, Seville, 41009, Spain
Kharkiv Governorate
Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital, Lviv, Kharkiv Governorate, 79010, Ukraine
KIEV Governorate
Ukrainian medical rehabilitation center for children with organic lesions of the nervous system, Kyiv, KIEV Governorate, 04209, Ukraine
Tavria Okruha
KZ "Dnipropetrovska oblasna dytiacha klinichna likarnia" DOR, Dnipropetrovsk, Tavria Okruha, 49100, Ukraine
State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Kharkiv, 61068, Ukraine
Addenbrookes Hospital, Cambridge, CB2 0QQ, United Kingdom
Royal Hospital for Children and Young People, Edinburgh, EH51, United Kingdom
Great Ormond Street Hospital For Children, London, WC1N 3JH, United Kingdom