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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003192-34 | EudraCT Number | ||
| 2023-507196-22-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Chugai Pharmaceutical | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Satralizumab | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Satralizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of California Irvine - Manchester Pavilion |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Placebo | Other | 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. |
|
| Proportion of Participants Receiving Rescue Therapy | Up to approximately 44 months |
| Annualized Rate of Inpatient Hospitalizations | Up to approximately 44 months |
| Irvine |
| California |
| 92697 |
| United States |
| University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center) | Aurora | Colorado | 80045 | United States |
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| University of Florida College of Medicine Gainesville | Gainesville | Florida | 32608 | United States |
| Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis | Owosso | Michigan | 48867 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55902 | United States |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110 | United States |
| NYU Langone | New York | New York | 10003 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44915 | United States |
| Premier Neurology | Greenville | South Carolina | 29605 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Brain and Mind Research Institute | Camperdown | New South Wales | 2050 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Perron Institute for Neurological and Translational Science | Nedlands | Western Australia | 6009 | Australia |
| Instituto de Neurologia de Curitiba | Curitiba | Paraná | 81210-310 | Brazil |
| Instituto do Cerebro do Rio Grande do Sul | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Centro de Pesquisas Clinicas | São Paulo | São Paulo | 01228-200 | Brazil |
| Hospital Universitario Gaffree e Guinle | Rio de Janeiro | 20270-004 | Brazil |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| MUCH - Montreal Neurological Institute & Hospital | Montreal | Quebec | H3A 2B4 | Canada |
| Hopital Pierre Wertheimer | Bron | 69677 | France |
| CH de Bicêtre | Le Kremlin-Bicêtre | 94275 | France |
| ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic | Berlin | 13125 | Germany |
| St. Josef-Hospital, Klinik für Neurologie | Bochum | 44791 | Germany |
| Vestische Kinder- und Jugendklinik Datteln | Datteln | 45711 | Germany |
| Universitätsklinikum Düsseldorf | Düsseldorf | 40225 | Germany |
| Universitätsklinikum Mannheim | Mannheim | 68167 | Germany |
| Klinikum Großhadern, LMU | Munich | 81377 | Germany |
| Hadassah University Hospital Ein Kerem | Jerusalem | 9112001 | Israel |
| Fondazione Istituto Neurologico Mondino IRCCS | Pavia | Lombardy | 27100 | Italy |
| Azienda Sanitaria Ospedaliera S. Luigi Gonzaga | Orbassano | Piedmont | 10043 | Italy |
| AOU Policlinico V. Emanuele - P.O G. Rodolico | Catania | Sicily | 95123 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona | Verona | Veneto | 37134 | Italy |
| Chiba University Hospital | Chiba | 260-8677 | Japan |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| Southern Tohoku Medical Clinic | Fukushima | 963-8052 | Japan |
| Kobe University Hospital | Hyōgo | 650-0017 | Japan |
| Kitasato University Hospital | Kanagawa | 252-0375 | Japan |
| Tohoku University Hospital | Miyagi | 980-8574 | Japan |
| The University of Osaka Hospital | Osaka | 565-0871 | Japan |
| The Jikei University Hospital | Tokyo | 105-8471 | Japan |
| Juntendo University Hospital | Tokyo | 113-8431 | Japan |
| Tokyo Medical University Hospital | Tokyo | 160-0023 | Japan |
| Keio University Hospital | Tokyo | 160-8582 | Japan |
| Wielospecjalistyczna Poradnia Lekarska Synapsis | Katowice | 40-123 | Poland |
| Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie | Warsaw | 02-097 | Poland |
| SPSK nr 1 | Zabrze | 41-800 | Poland |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| ID | Term |
|---|---|
| D000098542 | Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease |
| ID | Term |
|---|---|
| D020274 | Autoimmune Diseases of the Nervous System |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000655944 | satralizumab |
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