A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
NCT ID: NCT05271409
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
152 participants
INTERVENTIONAL
2022-08-30
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Satralizumab
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
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
12 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic- Scottsdale
Scottsdale, Arizona, United States
University of California Irvine - Manchester Pavilion
Irvine, California, United States
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
Aurora, Colorado, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Florida College of Medicine Gainesville
Gainesville, Florida, United States
Nemours Children's Clinic - of the Nemours Foundation
Jacksonville, Florida, United States
Meridian Clinical Research, LLC
Savannah, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Consultants in Neurology Ltd
Northbrook, Illinois, United States
Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis
Owosso, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
NYU Langone
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
OhioHealth Research Institute
Columbus, Ohio, United States
Premier Neurology
Greenville, South Carolina, United States
Baylor College of Medicine
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Brain and Mind Research Institute
Camperdown, New South Wales, Australia
John Hunter Hospital
New Lambton, New South Wales, Australia
Sydney Children's Hospital
Randwick, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Perron Institute for Neurological and Translational Science
Nedlands, Western Australia, Australia
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil
Instituto do Cerebro do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisas Clinicas
São Paulo, São Paulo, Brazil
Hospital Universitario Gaffree e Guinle
Rio de Janeiro, , Brazil
London Health Sciences Centre Uni Campus
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Unity Health Toronto - St. Michael's Hospital
Toronto, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
MUCH - Montreal Neurological Institute & Hospital
Montreal, Quebec, Canada
Hopital Pierre Wertheimer
Bron, , France
CH de Bicêtre
Le Kremlin-Bicêtre, , France
CHU de Toulouse - Hôpital Purpan
Toulouse, , France
NeuroCure Clinical Research Center (NCRC)
Berlin, , Germany
St. Josef-Hospital, Klinik für Neurologie
Bochum, , Germany
Vestische Kinder- und Jugendklinik Datteln
Datteln, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Neurology UKSH Campus Kiel
Kiel, , Germany
Universitätsklinikum Mannheim
Mannheim, , Germany
Klinikum Großhadern, LMU
Munich, , Germany
Hadassah University Hospital Ein Kerem
Jerusalem, , Israel
Ospedale Pediatrico Bambino Gesù
Rome, Lazio, Italy
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, Italy
Fondazione Istituto Neurologico Mondino IRCCS
Pavia, Lombardy, Italy
Azienda Sanitaria Ospedaliera S. Luigi Gonzaga
Orbassano, Piedmont, Italy
AOU Policlinico V. Emanuele - P.O G. Rodolico
Catania, Sicily, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Veneto, Italy
Chiba University Hospital
Chiba, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Southern Tohoku Medical Clinic
Fukushima, , Japan
Kobe University Hospital
Hyōgo, , Japan
Kitasato University Hospital
Kanagawa, , Japan
Tohoku University Hospital
Miyagi, , Japan
Tohoku Medical and Pharmaceutical University Hospital
Miyagi, , Japan
The University of Osaka Hospital
Osaka, , Japan
Saitama Medical Center
Saitama, , Japan
The Jikei University Hospital
Tokyo, , Japan
Juntendo University Hospital
Tokyo, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Keio University Hospital
Tokyo, , Japan
Tokyo Women's Medical University Hospital
Tokyo, , Japan
Wielospecjalistyczna Poradnia Lekarska Synapsis
Katowice, , Poland
Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Centrum Medyczne "MEDYK"
Rzeszów, , Poland
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
Warsaw, , Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, , Poland
SPSK nr 1
Zabrze, , Poland
National Cancer Center
Goyang-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Reference Study ID Number: WN43194 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S.)
Email: [email protected]
Other Identifiers
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2021-003192-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-507196-22-00
Identifier Type: CTIS
Identifier Source: secondary_id
WN43194
Identifier Type: -
Identifier Source: org_study_id