A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- 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
Trial sites (53)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| University of California Irvine - Manchester Pavilion | Irvine | California | |
| University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center) | Aurora | Colorado | |
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | |
| University of Florida College of Medicine Gainesville | Gainesville | Florida | |
| Johns Hopkins | Baltimore | Maryland | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis | Owosso | Michigan | |
| Mayo Clinic - Rochester | Rochester | Minnesota | |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | |
| NYU Langone | New York | New York | |
| University of Cincinnati | Cincinnati | Ohio | |
| Cleveland Clinic Foundation | Cleveland | Ohio | |
| Premier Neurology | Greenville | South Carolina | |
| Medical College of Wisconsin | Milwaukee | Wisconsin | |
| Brain and Mind Research Institute | Camperdown | New South Wales | |
| Monash Medical Centre | Clayton | Victoria | |
| Perron Institute for Neurological and Translational Science | Nedlands | Western Australia | |
| Instituto de Neurologia de Curitiba | Curitiba | Paraná | |
| Instituto do Cerebro do Rio Grande do Sul | Porto Alegre | Rio Grande do Sul | |
| Centro de Pesquisas Clinicas | São Paulo | São Paulo | |
| Hospital Universitario Gaffree e Guinle | Rio de Janeiro | Brazil | |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | |
| MUCH - Montreal Neurological Institute & Hospital | Montreal | Quebec | |
| 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 | |
| Azienda Sanitaria Ospedaliera S. Luigi Gonzaga | Orbassano | Piedmont | |
| Azienda Ospedaliera Universitaria Integrata Verona | Verona | Veneto | |
| Chiba University Hospital | Chiba | Japan | |
| Kyushu University Hospital | Fukuoka | Japan | |
| Southern Tohoku Medical Clinic | Fukushima | Japan | |
| Kobe University Hospital | Hyōgo | Japan |
+ 13 more sites — see the full list on the official registry below.
More Hoffmann-La Roche trials in Poland
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05271409 on ClinicalTrials.gov ↗ ← All trials in Poland