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En undersøgelse for at evaluere sikkerheden og effektiviteten af ​​Ocrelizumab i sammenligning med Fingolimod hos børn og unge med recidiverende-remitterende multipel sklerose (Operetta 2)

14. juli 2026 opdateret af: Hoffmann-La Roche

En fase III multicenter, randomiseret, dobbelt-blind, dobbelt-dummy undersøgelse til evaluering af sikkerhed og effektivitet af Ocrelizumab i sammenligning med Fingolimod hos børn og unge med recidiverende-remitterende multipel sklerose

Dette dobbeltblindede, dobbelt-dummy studie vil evaluere sikkerheden og effektiviteten af ​​ocrelizumab sammenlignet med fingolimod hos børn og unge med recidiverende-remitterende multipel sklerose i alderen mellem 10 og < 18 år over en varighed på mindst 96 uger.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette fase III randomiserede, dobbeltblinde, dobbelt-dummy multicenter studie vil evaluere sikkerheden og effektiviteten af ​​ocrelizumab administreret ved IV-infusion hver 24. uge sammenlignet med fingolimod indtaget oralt dagligt hos børn og unge med multipel sklerose i alderen mellem 10 og < 18 år. flere år. Undersøgelsen planlægger at inkludere 233 patienter i en 1:1 randomisering (ocrelizumab:fingolimod), globalt. Denne undersøgelse består af en dobbeltblind, dobbelt dummy-periode, hvor patienter vil blive behandlet med enten aktivt ocrelizumab eller aktivt fingolimod i mindst 96 uger. Patienter, der gennemfører den dobbeltblindede periode, vil blive tilbudt muligheden for at gå ind i en valgfri åben forlænget behandlingsperiode på mindst 144 uger med ocrelizumab.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

188

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • San Miguel de Tucumán, Argentina, T4000AXL
        • Centro de Investigaciones Médicas Tucuman
  • Australien
    • Victoria
      • Parkville, Victoria, Australien, 3052
        • Royal Children's Hospital Melbourne - PIN
  • Belgien
      • Ghent, Belgien, 9000
        • Uz Gent
  • Brasilien
      • São Paulo, Brasilien, 05403-900
        • Inst. Da Criança- Faculdade de Medicina Usp
    • Federal District
      • Brasília, Federal District, Brasilien, 70200-730
        • L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
    • Paraná
      • Curitiba, Paraná, Brasilien, 81210-310
        • Instituto de Neurologia de Curitiba
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90610-000
        • Hospital Sao Lucas - PUCRS
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90430-001
        • Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR
    • São Paulo
      • São Paulo, São Paulo, Brasilien, 01228-000
        • CPQuali Pesquisa Clínica Sao Paulo
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children
  • Det Forenede Kongerige
      • Edinburgh, Det Forenede Kongerige, EH51
        • Royal Hospital for Children and Young People
  • Estland
      • Tallinn, Estland, 11315
        • Astra Kliinik
      • Tartu, Estland, 50406
        • Tartu University Hospital
  • Forenede Stater
    • California
      • La Jolla, California, Forenede Stater, 92037-1337
        • UC San Diego
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Children's Hospital Colorado
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20010
        • Children's National Hospital
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins Medicine
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115-5724
        • Boston Children's Hospital Central Pharmacy
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63101
        • Washington University
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195-0001
        • Cleveland Clinic, Mellen Center for Multiple Sclerosis
      • Columbus, Ohio, Forenede Stater, 43235
        • The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104-4319
        • The Children's Hospital of Philadelphia
    • Texas
      • Houston, Texas, Forenede Stater, 77030-2608
        • Baylor College of Medicine/Texas Children's Hospital
  • Frankrig
      • Le Kremlin-Bicêtre, Frankrig, 94275
        • Centre Hospitalier Universitaire de Bicêtre
      • Montpellier, Frankrig, 34295
        • CHRU de Montpellier, Hopital Gui de Chauliac
      • Strasbourg, Frankrig, 67091
        • Hôpital de Hautepierre
    • Rhône
      • Bron, Rhône, Frankrig, 69003
        • Hospices Civils de Lyon - Hôpital Pierre Wertheimer
  • Grækenland
      • Thessaloniki, Grækenland, 552 36
        • St. Luke's Hospital
    • Attica
      • Athens, Attica, Grækenland, 115 28
        • Eginitio University General Hospital of Athens
      • Chaïdári, Attica, Grækenland, 124 62
        • University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
  • Indien
    • Karnataka
      • Bangalore North, Karnataka, Indien, 560022
        • Sparsh Super Speciality Hospital
  • Italien
    • Abruzzo
      • Chieti, Abruzzo, Italien, 66100
        • Universita? G. D'Annunzio
    • Apulia
      • Bari, Apulia, Italien, 70124
        • Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari
    • Lazio
      • Rome, Lazio, Italien, 00165
        • Ospedale Pediatrico Bambino Gesu
      • Rome, Lazio, Italien, 00189
        • Azienda Ospedaliera Sant'Andrea
    • Lombardy
      • Milan, Lombardy, Italien, 20133
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
    • Sicily
      • Catania, Sicily, Italien, 95123
        • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
  • Letland
      • Riga, Letland, LV-1004
        • Children's Clinical University Hospital
  • Marokko
      • Marrakesh, Marokko, 40000
        • CHU Mohammed VI
  • 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 Médico Camino S.C.
    • Michoacán
      • Morelia, Michoacán, Mexico, 58260
        • Centro de Investigación Clínica Chapultepec S. A. de C. V.
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80020
        • Neurociencias Estudios Clinicos S.C.
  • Polen
      • Gda?sk, Polen, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Późna, Polen, 60-355
        • Uniwersytecki Szpital Kliniczny w Poznaniu
      • Warsaw, Polen, 04-730
        • Instytut Pomnik Centrum Zdrowia Dziecka
      • Warsaw, Polen, 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
  • Rumænien
      • Bucharest, Rumænien, 022102
        • Victor Gomoiu Clinical Hospital for Children
      • Bucharest, Rumænien, 041914
        • Prof Dr Alexandru Obregia Clinical Psychiatric Hospital
  • Schweiz
      • Zurich, Schweiz, 8008
        • Universitäts-Kinderspital Zürich - Eleonorenstiftung
  • Serbien
      • Belgrade, Serbien, 11000
        • Clinic for Neurology and Psychiatry for Children and Youth
      • Belgrade, Serbien, 11000
        • Childrens University Hospital
      • Belgrade, Serbien, 11000
        • Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
      • Niš, Serbien, 18000
        • University Clinical Centre of Nis
  • Spanien
      • Barcelona, Spanien, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spanien, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spanien, 28006
        • Hospital Universitario de La Princesa
      • Seville, Spanien, 41009
        • Hospital Universitario Virgen Macarena
    • Barcelona
      • Esplugues de Llobregas, Barcelona, Spanien, 08950
        • Hospital Sant Joan de Déu
  • Tyskland
      • Datteln, Tyskland, 45711
        • Vestische Kinder- und Jugendklinik Datteln
      • Dresden, Tyskland, 01307
        • Universitaetsklinikum Carl Gustav Carus an der TU Dresden
  • Ukraine
    • Kharkiv Governorate
      • Lviv, Kharkiv Governorate, Ukraine, 79010
        • Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital
  • Ungarn
      • Budapest, Ungarn, 1094
        • Semmelweis Egyetem
      • Debrecen, Ungarn, H-4032
        • Debreceni Egyetem Klinikai Központ
  • Østrig
      • Vienna, Østrig, 1090
        • Medizinische Universität Wien

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

10 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Kropsvægt ≥ 50 kg
  • Diagnose af RRMS i overensstemmelse med International Pediatric Multiple Sclerosis Study Group (IPMSSG) kriterier for pædiatrisk MS, Version 2012 eller McDonald kriterier 2017
  • EDSS ved screening: 0-5,5, inklusive
  • Neurologisk stabilitet i ≥ 30 dage før screening og mellem screening og dag 1
  • Mindst ét ​​MS-tilbagefald i løbet af det foregående år eller to MS-tilbagefald inden for de foregående 2 år eller tegn på mindst én Gd-forstærkende læsion på MR inden for 6 måneder

Ekskluderingskriterier:

  • Kendt tilstedeværelse eller mistanke om andre neurologiske lidelser, der kan efterligne MS
  • Betydelige ukontrollerede somatiske sygdomme, kendt aktiv infektion eller enhver anden væsentlig tilstand, der kan forhindre patienten i at deltage i undersøgelsen
  • Patient med alvorlig hjertesygdom eller signifikante fund på screenings-EKG

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ocrelizumab
Participants will receive ocrelizumab, as IV infusion 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 QD capsule.
Medicin: Ocrelizumab
Ocrelizumab, 300 milligrams (mg) will be administered as 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.
Andre navne:
  • RO4964913; Ocrevus
Andet: Fingolimod Placebo
Fingolimod matching placebo will be administered QD as a capsule.
Aktiv komparator: Fingolimod
Participants will receive fingolimod 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.
Andet: Ocrelizumab Placebo
Ocrelizumab matching placebo will be administered as IV infusion on Day 1 and Day 15, and Q24W thereafter.
Medicin: Fingolimod
Fingolimod will be administered QD 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).
Andre navne:
  • Gilenya®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Protocol-defined Annualized Relapse Rate (ARR)
Tidsramme: Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)
The population-level summary is rate ratio of ARR. The ARR is calculated as the total number of protocol-defined relapses divided by the total patient-years. Protocol-defined relapse is the occurrence of new/worsening neurological symptoms attributable to multiple sclerosis (MS) and immediately preceded by relatively stable or improving neurological state for ≥ 30 days. Symptoms must persist for >24 hours & should not be attributable to confounding clinical factors. The new/worsening neurological symptoms must be accompanied by objective neurological worsening consistent with an increase of at least half a step on the expanded disability status scale (EDSS) score, or 2 points on one of the appropriate functional system (FS) scores, or 1 point on two or more of the appropriate FS scores. The change must affect the selected FS (i.e., pyramidal, ambulation, cerebellar, brainstem, sensory, or visual). Adjusted values were reported. OM assessed non inferiority of ocrelizumab vs fingolimod.
Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Protocol-defined ARR
Tidsramme: Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)
The population-level summary is rate ratio of ARR. The ARR is calculated as the total number of protocol-defined relapses divided by the total patient-years. Protocol-defined relapse is the occurrence of new/worsening neurological symptoms attributable to multiple sclerosis (MS) and immediately preceded by relatively stable or improving neurological state for ≥ 30 days. Symptoms must persist for >24 hours & should not be attributable to confounding clinical factors. The new/worsening neurological symptoms must be accompanied by objective neurological worsening consistent with an increase of at least half a step on the expanded disability status scale (EDSS) score, or 2 points on one of the appropriate functional system (FS) scores, or 1 point on two or more of the appropriate FS scores. The change must affect the selected FS (i.e., pyramidal, ambulation, cerebellar, brainstem, sensory, or visual). Adjusted values were reported. OM assessed non superiority of ocrelizumab vs fingolimod.
Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)
Number of New or Enlarging T2-hyperintense Lesions (T2 Lesions), as Detected by Brain Magnetic Resonance Imaging (MRI)
Tidsramme: Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)
Number of new or enlarging T2 lesions for each participant was calculated as the sum of the individual number of new or enlarging T2 lesions as detected by brain MRI.
Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)
Number of T1 Gd Lesions at Week 12
Tidsramme: At Week 12
Brain MRI with and without a Gd-contrast agent were performed to assess the number of Gd lesions.
At Week 12
Number of Participants With Adverse Events (AEs)
Tidsramme: Up to approximately 7 years
An AE was defined as any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Up to approximately 7 years
Maximum Serum Concentration (Cmax) of Ocrelizumab
Tidsramme: Cycle (1 Cycle=24 weeks)
Cycle (1 Cycle=24 weeks)
Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC Tau) of Ocrelizumab
Tidsramme: Cycle 1 (1 Cycle=24 weeks)
Cycle 1 (1 Cycle=24 weeks)
Number of Participants With Anti-drug Antibodies (ADAs) to Ocrelizumab
Tidsramme: Up to approximately 7 years
Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response). The total number of participants who developed ADAs to atezolizumab was determined by summing the ADA-positive participants across all timepoints.
Up to approximately 7 years
Levels of Cluster of Differentiation 19 (CD19) + B-cell Count in Blood
Tidsramme: Up to approximately 7 years
CD19+ B-cell count in blood will be assessed using flow cytometry.
Up to approximately 7 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Samarbejdspartnere

PPD Development, LP

Efterforskere

  • Studieleder: Clinical Trials, Hoffmann-La Roche

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. maj 2022

Primær færdiggørelse (Faktiske)

9. juni 2025

Studieafslutning (Anslået)

17. september 2029

Datoer for studieregistrering

Først indsendt

16. november 2021

Først indsendt, der opfyldte QC-kriterier

16. november 2021

Først opslået (Faktiske)

17. november 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Kvalificerede forskere kan anmode om adgang til data på individuelt patientniveau gennem platformen for anmodninger om kliniske undersøgelsesdata (www.clinicalstudydatarequest.com). Yderligere detaljer om Roches kriterier for kvalificerede undersøgelser er tilgængelige her (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For yderligere detaljer om Roches globale politik om deling af oplysninger om kliniske undersøgelser, og hvordan man anmoder om adgang til relaterede kliniske undersøgelsesdokumenter, se her (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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