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De klinische studie NCT05271409 (Meteoroid) voor Myeline-oligodendrocyt glycoproteïne antilichaam-geassocieerde ziekte (MOGAD) is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (Meteoroid) Fase 3 152 Dubbelblind Adolescenten Open-label

Rekruterend
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De klinische studie NCT05271409 (Meteoroid) onderzoekt behandeling bij Myeline-oligodendrocyt glycoproteïne antilichaam-geassocieerde ziekte (MOGAD). Deze Fase 3 interventioneel-studie heeft de status rekruterend. Het doel is om 152 deelnemers te includeren vanaf 30 augustus 2022. De studie wordt geleid door Roche en de voltooiing is gepland op 31 december 2028. Laatste update op ClinicalTrials.gov: 13 maart 2026.
Beknopte samenvatting
The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period. Participants who experience an adjudicated relapse or complete the DB period can enter open-label extension (OLE) period. After the primary clinical cutoff date (CCOD), additional adolescen...Toon meer
Officiële titel

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab as Monotherapy or in Addition to Baseline Therapy in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)

Aandoeningen
Myeline-oligodendrocyt glycoproteïne antilichaam-geassocieerde ziekte (MOGAD)
Andere studie-ID's
  • Meteoroid
  • WN43194
  • 2021-003192-34 (EudraCT-nummer)
  • 2023-507196-22-00 (EU-studienummer (CTIS))
NCT-ID
NCT05271409
Startdatum (Werkelijk)
2022-08-30
Laatste update geplaatst
2026-03-13
Verwachte einddatum
2028-12-31
Inschrijving (Geschat)
152
Studietype
Interventioneel
FASE
Fase 3
Status
Rekruterend
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Dubbelblind
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelSatralizumab
In the DB treatment period, participants will receive satralizumab at Weeks 0, 2, 4 (loading doses) and maintenance doses every 4 weeks (Q4W) thereafter. In the OLE period, all participants will receive open-label treatment with satralizumab. Additional adolescent participants will be directly enrolled in the OLE period to receive satralizumab.
Satralizumab
Study drug will be administered by subcutaneous (SC) injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit.
Placebo-comparatorPlacebo
In the DB treatment period, participants will receive satralizumab matching placebo at Weeks 0, 2, 4 (loading doses) and maintenance doses Q4W thereafter. In the OLE period, all participants will receive open label treatment with satralizumab.
PLACEBO
Placebo will be administered by SC injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Time From Randomization to the First Occurrence of a MOGAD Relapse in the DB Treatment Period, as Determined by an Adjudication Committee (CEC)
Up to approximately 44 months
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Annualized Rate of Adjudicated MOGAD Relapses
Up to approximately 44 months
Annualized Rate of Active Lesions on Magnetic Resonance Imaging (MRI) of the Neuroaxis
Up to approximately 44 months
Proportion of Participants Receiving Rescue Therapy
Up to approximately 44 months
Annualized Rate of Inpatient Hospitalizations
Up to approximately 44 months
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Kind, Volwassene, Oudere volwassene
Minimumleeftijd
12 Years
Geslachten die in aanmerking komen voor de studie
Allen
  • Participants who are aged >=12 years at the time of signing Informed Consent Form
  • Confirmed diagnosis of MOGAD with a history of >=1 MOGAD relapse in the 12 months prior to screening or >=2 attacks in the 24 months prior to screening
  • Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening
  • High-contrast visual acuity (HCVA) better than 20/800 in each eye at screening
  • Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening
  • For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab

  • Presence of aquaporin-4-antibodies immunoglobin G (AQP4-IgG) in the serum
  • History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis
  • Any concomitant disease other than MOGAD that may require treatment with ISTs or oral corticosteroids (OCS) or intravenous (IV) corticosteroids at doses > 20 milligrams (mg) prednisone equivalent per day for >21 days during the study
  • Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab
  • Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
  • Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
  • Participants with positive screening tests for hepatitis B and C
  • Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
  • History of severe allergic reaction to a biologic agent
Hoffmann-La Roche logoRoche289 actieve klinische studies om te verkennen
Chugai Pharmaceutical logoChugai Pharmaceutical
Centraal Contactpersoon
Contact: Reference Study ID Number: WN43194 https://forpatients.roche.com/, 888-662-6728 (U.S.), [email protected]
82 Studielocaties in 11 landen

Alabama

University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States
Rekruterend

Arizona

Mayo Clinic- Scottsdale, Scottsdale, Arizona, 85259, United States
Ingetrokken

California

University of California Irvine - Manchester Pavilion, Irvine, California, 92697, United States
Rekruterend

Colorado

University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center), Aurora, Colorado, 80045, United States
Rekruterend

District of Columbia

Medstar Georgetown University Hospital, Washington D.C., District of Columbia, 20007, United States
Rekruterend

Florida

University of Florida College of Medicine Gainesville, Gainesville, Florida, 32608, United States
Rekruterend
Nemours Children's Clinic - of the Nemours Foundation, Jacksonville, Florida, 32207, United States
Rekruterend

Georgia

Meridian Clinical Research, LLC, Savannah, Georgia, 31406, United States
Ingetrokken

Illinois

Northwestern University, Chicago, Illinois, 60611, United States
Ingetrokken
Consultants in Neurology Ltd, Northbrook, Illinois, 60062, United States
Ingetrokken

Maryland

Johns Hopkins, Baltimore, Maryland, 21287, United States
Rekruterend

Massachusetts

Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
Rekruterend

Michigan

Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis, Owosso, Michigan, 48867, United States
Rekruterend

Minnesota

Mayo Clinic - Rochester, Rochester, Minnesota, 55902, United States
Rekruterend

Missouri

Washington University School of Medicine in St. Louis, St Louis, Missouri, 63110, United States
Rekruterend

New York

NYU Langone, New York, New York, 10003, United States
Rekruterend

North Carolina

Duke University Medical Center, Durham, North Carolina, 27710, United States
Ingetrokken

Ohio

University of Cincinnati, Cincinnati, Ohio, 45267, United States
Actief, niet rekruterend
Cleveland Clinic Foundation, Cleveland, Ohio, 44915, United States
Rekruterend
OhioHealth Research Institute, Columbus, Ohio, 43214, United States
Ingetrokken

South Carolina

Premier Neurology, Greenville, South Carolina, 29605, United States
Afgerond

Texas

Baylor College of Medicine, Houston, Texas, 77030, United States
Ingetrokken

Wisconsin

Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States
Afgerond

New South Wales

Brain and Mind Research Institute, Camperdown, New South Wales, 2050, Australia
Rekruterend
John Hunter Hospital, New Lambton, New South Wales, 2305, Australia
Rekruterend
Sydney Children's Hospital, Randwick, New South Wales, 2031, Australia
Rekruterend
Royal North Shore Hospital, St Leonards, New South Wales, 2065, Australia
Ingetrokken

Victoria

Box Hill Hospital, Box Hill, Victoria, 3128, Australia
Ingetrokken
Monash Medical Centre, Clayton, Victoria, 3168, Australia
Rekruterend
St Vincent's Hospital Melbourne, Fitzroy, Victoria, 3065, Australia
Ingetrokken
Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia
Ingetrokken

Western Australia

Perron Institute for Neurological and Translational Science, Nedlands, Western Australia, 6009, Australia
Rekruterend

Paraná

Instituto de Neurologia de Curitiba, Curitiba, Paraná, 81210-310, Brazil
Rekruterend

Rio Grande do Sul

Instituto do Cerebro do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Rekruterend

São Paulo

Centro de Pesquisas Clinicas, São Paulo, São Paulo, 01228-200, Brazil
Rekruterend
Hospital Universitario Gaffree e Guinle, Rio de Janeiro, 20270-004, Brazil
Rekruterend

Ontario

London Health Sciences Centre Uni Campus, London, Ontario, N6A 5A5, Canada
Rekruterend
Children's Hospital of Eastern Ontario, Ottawa, Ontario, K1H 8L1, Canada
Rekruterend
Unity Health Toronto - St. Michael's Hospital, Toronto, Ontario, M5B 1W8, Canada
Ingetrokken
The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada
Rekruterend

Quebec

MUCH - Montreal Neurological Institute & Hospital, Montreal, Quebec, H3A 2B4, Canada
Rekruterend
Hopital Pierre Wertheimer, Bron, 69677, France
Rekruterend
CH de Bicêtre, Le Kremlin-Bicêtre, 94275, France
Rekruterend
CHU de Toulouse - Hôpital Purpan, Toulouse, 31059, France
Ingetrokken
NeuroCure Clinical Research Center (NCRC), Berlin, 10117, Germany
Actief, niet rekruterend
St. Josef-Hospital, Klinik für Neurologie, Bochum, 44791, Germany
Actief, niet rekruterend
Vestische Kinder- und Jugendklinik Datteln, Datteln, 45711, Germany
Rekruterend
Universitätsklinikum Düsseldorf, Düsseldorf, 40225, Germany
Actief, niet rekruterend
Neurology UKSH Campus Kiel, Kiel, 24105, Germany
Actief, niet rekruterend
Universitätsklinikum Mannheim, Mannheim, 68167, Germany
Actief, niet rekruterend
Klinikum Großhadern, LMU, Munich, 81377, Germany
Actief, niet rekruterend
Hadassah University Hospital Ein Kerem, Jerusalem, 9112001, Israel
Rekruterend

Lazio

Ospedale Pediatrico Bambino Gesù, Rome, Lazio, 00165, Italy
Actief, niet rekruterend

Lombardy

IRCCS Ospedale San Raffaele, Milan, Lombardy, 20132, Italy
Actief, niet rekruterend
Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Lombardy, 20133, Italy
Ingetrokken
Fondazione Istituto Neurologico Mondino IRCCS, Pavia, Lombardy, 27100, Italy
Rekruterend

Piedmont

Azienda Sanitaria Ospedaliera S. Luigi Gonzaga, Orbassano, Piedmont, 10043, Italy
Rekruterend

Sicily

AOU Policlinico V. Emanuele - P.O G. Rodolico, Catania, Sicily, 95123, Italy
Rekruterend

Veneto

Azienda Ospedaliera Universitaria Integrata Verona, Verona, Veneto, 37134, Italy
Rekruterend
Chiba University Hospital, Chiba, 260-8677, Japan
Rekruterend
Kyushu University Hospital, Fukuoka, 812-8582, Japan
Rekruterend
Southern Tohoku Medical Clinic, Fukushima, 963-8052, Japan
Rekruterend
Kobe University Hospital, Hyōgo, 650-0017, Japan
Rekruterend
Kitasato University Hospital, Kanagawa, 252-0375, Japan
Rekruterend
Tohoku University Hospital, Miyagi, 980-8574, Japan
Rekruterend
Tohoku Medical and Pharmaceutical University Hospital, Miyagi, 983-8512, Japan
Rekruterend
The University of Osaka Hospital, Osaka, 565-0871, Japan
Rekruterend
Saitama Medical Center, Saitama, 350-8550, Japan
Rekruterend
The Jikei University Hospital, Tokyo, 105-8471, Japan
Rekruterend
Juntendo University Hospital, Tokyo, 113-8431, Japan
Rekruterend
Tokyo Medical University Hospital, Tokyo, 160-0023, Japan
Rekruterend
Keio University Hospital, Tokyo, 160-8582, Japan
Rekruterend
Tokyo Women's Medical University Hospital, Tokyo, 162-8666, Japan
Ingetrokken
Wielospecjalistyczna Poradnia Lekarska Synapsis, Katowice, 40-123, Poland
Rekruterend
Szpital Uniwersytecki w Krakowie, Krakow, 30-688, Poland
Ingetrokken
Centrum Medyczne "MEDYK", Rzeszów, 35-055, Poland
Ingetrokken
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie, Warsaw, 02-097, Poland
Rekruterend
Instytut Pomnik Centrum Zdrowia Dziecka, Warsaw, 04-730, Poland
Rekruterend
SPSK nr 1, Zabrze, 41-800, Poland
Actief, niet rekruterend
National Cancer Center, Goyang-si, 10408, South Korea
Rekruterend
Seoul National University Hospital, Seoul, 03080, South Korea
Actief, niet rekruterend
Samsung Medical Center, Seoul, 06351, South Korea
Rekruterend