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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 III 152 Doble ciego Adolescentes Etiqueta abierta

Reclutando
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El ensayo clínico NCT05271409 (Meteoroid) está diseñado para estudiar el tratamiento de Enfermedad asociada a anticuerpos contra la glicoproteína de oligodendrocitos de mielina (MOGAD). Es un estudio intervencionista de Fase III. Su estado actual es: reclutando. El estudio se inició el 30 de agosto de 2022, con el objetivo de reclutar a 152 participantes. Dirigido por Roche, se espera que finalice el 31 de diciembre de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 13 de marzo de 2026.
Resumen
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...Mostrar más
Título oficial

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)

Condiciones médicas
Enfermedad asociada a anticuerpos contra la glicoproteína de oligodendrocitos de mielina (MOGAD)
Otros ID del estudio
  • Meteoroid
  • WN43194
  • 2021-003192-34 (Número EudraCT)
  • 2023-507196-22-00 (Número CTIS (UE))
Número del NCT
NCT05271409
Inicio del estudio (real)
2022-08-30
Última actualización
2026-03-13
Fecha de finalización (estimada)
2028-12-31
Inscripción (prevista)
152
Tipo de estudio
Intervencionista
FASE
Fase III
Estado general
Reclutando
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Doble ciego
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalSatralizumab
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.
Comparador placeboPlacebo
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.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Niño, Adulto, Adulto mayor
Edad mínima
12 Years
Criterios de sexo
Todos
  • 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 estudios activos para explorar
Chugai Pharmaceutical logoChugai Pharmaceutical
Contactos centrales del estudio
Contacto: Reference Study ID Number: WN43194 https://forpatients.roche.com/, 888-662-6728 (U.S.), [email protected]
82 Centros del estudio en 11 países

Alabama

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

Arizona

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

California

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

Colorado

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

District of Columbia

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

Florida

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

Georgia

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

Illinois

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

Maryland

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

Massachusetts

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

Michigan

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

Minnesota

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

Missouri

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

New York

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

North Carolina

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

Ohio

University of Cincinnati, Cincinnati, Ohio, 45267, United States
Activo, no reclutando
Cleveland Clinic Foundation, Cleveland, Ohio, 44915, United States
Reclutando
OhioHealth Research Institute, Columbus, Ohio, 43214, United States
Retirado

South Carolina

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

Texas

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

Wisconsin

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

New South Wales

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

Victoria

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

Western Australia

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

Paraná

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

Rio Grande do Sul

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

São Paulo

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

Ontario

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

Quebec

MUCH - Montreal Neurological Institute & Hospital, Montreal, Quebec, H3A 2B4, Canada
Reclutando
Hopital Pierre Wertheimer, Bron, 69677, France
Reclutando
CH de Bicêtre, Le Kremlin-Bicêtre, 94275, France
Reclutando
CHU de Toulouse - Hôpital Purpan, Toulouse, 31059, France
Retirado
NeuroCure Clinical Research Center (NCRC), Berlin, 10117, Germany
Activo, no reclutando
St. Josef-Hospital, Klinik für Neurologie, Bochum, 44791, Germany
Activo, no reclutando
Vestische Kinder- und Jugendklinik Datteln, Datteln, 45711, Germany
Reclutando
Universitätsklinikum Düsseldorf, Düsseldorf, 40225, Germany
Activo, no reclutando
Neurology UKSH Campus Kiel, Kiel, 24105, Germany
Activo, no reclutando
Universitätsklinikum Mannheim, Mannheim, 68167, Germany
Activo, no reclutando
Klinikum Großhadern, LMU, Munich, 81377, Germany
Activo, no reclutando
Hadassah University Hospital Ein Kerem, Jerusalem, 9112001, Israel
Reclutando

Lazio

Ospedale Pediatrico Bambino Gesù, Rome, Lazio, 00165, Italy
Activo, no reclutando

Lombardy

IRCCS Ospedale San Raffaele, Milan, Lombardy, 20132, Italy
Activo, no reclutando
Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Lombardy, 20133, Italy
Retirado
Fondazione Istituto Neurologico Mondino IRCCS, Pavia, Lombardy, 27100, Italy
Reclutando

Piedmont

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

Sicily

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

Veneto

Azienda Ospedaliera Universitaria Integrata Verona, Verona, Veneto, 37134, Italy
Reclutando
Chiba University Hospital, Chiba, 260-8677, Japan
Reclutando
Kyushu University Hospital, Fukuoka, 812-8582, Japan
Reclutando
Southern Tohoku Medical Clinic, Fukushima, 963-8052, Japan
Reclutando
Kobe University Hospital, Hyōgo, 650-0017, Japan
Reclutando
Kitasato University Hospital, Kanagawa, 252-0375, Japan
Reclutando
Tohoku University Hospital, Miyagi, 980-8574, Japan
Reclutando
Tohoku Medical and Pharmaceutical University Hospital, Miyagi, 983-8512, Japan
Reclutando
The University of Osaka Hospital, Osaka, 565-0871, Japan
Reclutando
Saitama Medical Center, Saitama, 350-8550, Japan
Reclutando
The Jikei University Hospital, Tokyo, 105-8471, Japan
Reclutando
Juntendo University Hospital, Tokyo, 113-8431, Japan
Reclutando
Tokyo Medical University Hospital, Tokyo, 160-0023, Japan
Reclutando
Keio University Hospital, Tokyo, 160-8582, Japan
Reclutando
Tokyo Women's Medical University Hospital, Tokyo, 162-8666, Japan
Retirado
Wielospecjalistyczna Poradnia Lekarska Synapsis, Katowice, 40-123, Poland
Reclutando
Szpital Uniwersytecki w Krakowie, Krakow, 30-688, Poland
Retirado
Centrum Medyczne "MEDYK", Rzeszów, 35-055, Poland
Retirado
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie, Warsaw, 02-097, Poland
Reclutando
Instytut Pomnik Centrum Zdrowia Dziecka, Warsaw, 04-730, Poland
Reclutando
SPSK nr 1, Zabrze, 41-800, Poland
Activo, no reclutando
National Cancer Center, Goyang-si, 10408, South Korea
Reclutando
Seoul National University Hospital, Seoul, 03080, South Korea
Activo, no reclutando
Samsung Medical Center, Seoul, 06351, South Korea
Reclutando