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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
Sponsor: Hoffmann-La Roche
Summary
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 adolescent participants may be enrolled directly into the OLE period.
Official title: 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)
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
152
Start Date
2022-08-30
Completion Date
2028-05-20
Last Updated
2026-06-08
Healthy Volunteers
No
Interventions
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.
Locations (54)
University of Alabama at Birmingham
Birmingham, Alabama, 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
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
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Premier Neurology
Greenville, South Carolina, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Brain and Mind Research Institute
Camperdown, New South Wales, Australia
Monash Medical Centre
Clayton, 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
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
MUCH - Montreal Neurological Institute & Hospital
Montreal, Quebec, Canada
Hopital Pierre Wertheimer
Bron, France
CH de Bicêtre
Le Kremlin-Bicêtre, France
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
Berlin, Germany
St. Josef-Hospital, Klinik für Neurologie
Bochum, Germany
Vestische Kinder- und Jugendklinik Datteln
Datteln, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Mannheim
Mannheim, Germany
Klinikum Großhadern, LMU
Munich, Germany
Hadassah University Hospital Ein Kerem
Jerusalem, Israel
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
The University of Osaka Hospital
Osaka, Japan
The Jikei University Hospital
Tokyo, Japan
Juntendo University Hospital
Tokyo, Japan
Tokyo Medical University Hospital
Tokyo, Japan
Keio University Hospital
Tokyo, Japan
Wielospecjalistyczna Poradnia Lekarska Synapsis
Katowice, Poland
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
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