A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis
Start Date
2/7/2025
Completion Date
2/26/2033
Summary
A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment.
Detailed Description
This study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate the efficacy, safety and tolerability of remibrutinib in gMG patients who are on stable SOC treatment. Approximately 180 eligible participants will be randomized in a ratio of 1:1, to receive either remibrutinib or matching placebo. The study consists of a Core Part (6-months double-blind treatment) and an Extension Part (up to 60-month open-label treatment).
Eligibility Criteria
Age Range: 18 years to 85 years
Interventions
Remibrutinib (Blinded)
Placebo
Remibrutinib (Open Label)
Conditions
Locations
Neuromuscular Research Center
Phoenix, Arizona 85013
United States
Honor Health Research Institute
Scottsdale, Arizona 85258
United States
Fullerton Neuro and Headache Ctr
Fullerton, California 92835
United States
University Of Southern California
Los Angeles, California 90033
United States
Univ Cali Irvine ALS Neuromuscular
Orange, California 92868
United States
California Pacific Medical Center
Sacramento, California 94115
United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia 20010-2975
United States
SFM Clinical Research LLC
Boca Raton, Florida 33487
United States
Homestead Assoc In Research Inc
Homestead, Florida 33033
United States
Neurology Associates PA
Maitland, Florida 32751
United States
AdventHealth
Orlando, Florida 32804
United States
Neurological Services of Orlando PA
Orlando, Florida 32806
United States
University of Chicago Medical Centr
Chicago, Illinois 60637
United States
Mid Atlantic Epilepsy and Sleep Ctr
Bethesda, Maryland 20817-1807
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Michigan State University-Department of Neurology
East Lansing, Michigan 48824
United States
Dent Neurological Institute
Buffalo, New York 14209
United States
Univ of Cincinnati Medical Center
Cincinnati, Ohio 45219
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
UT Health Science Center
Houston, Texas 77030
United States
University of WA Division of Cardio
Seattle, Washington 98195
United States
Center for Neurological Disorders G
Greenfield, Wisconsin 53228-1321
United States
Novartis Investigative Site
Rosario, Santa Fe Province 2000
Argentina
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Caba, C1055AAF
Argentina
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Capital Federal, C1023AAB
Argentina
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San Miguel de Tucumán, T4000AXL
Argentina
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Kogarah, New South Wales 2217
Australia
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Fitzroy, Victoria 3065
Australia
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Southport, 4215
Australia
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Leuven, Vlaams Brabant 3000
Belgium
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Salvador, Estado de Bahia 40050-410
Brazil
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Brasília, Federal District 70200-730
Brazil
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Caxias do Sul, Rio Grande do Sul 95070-560
Brazil
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Porto Alegre, Rio Grande do Sul 90035-903
Brazil
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Porto Alegre, Rio Grande do Sul 90480-110
Brazil
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São Paulo, São Paulo 05403-000
Brazil
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Edmonton, Alberta T6G 2B7
Canada
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London, Ontario N6A 5W9
Canada
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Ottawa, Ontario K1H 8L6
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Québec, Quebec G1J 1Z4
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Hefei, Anhui 230001
China
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Guangzhou, Guangdong 510080
China
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Shijiazhuang, Hebei 50030
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Zhengzhou, Henan 450003
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Wuhan, Hubei 430030
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Wuxi, Jiangsu 214023
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Changchun, Jilin 130021
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Beijing, 100034
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Beijing, 100730
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Qingdao, 266000
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Shanghai, 200040
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Shanghai, 200080
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Bordeaux, 33076
France
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Nice, 06000
France
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Paris, 75013
France
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Paris, 75940
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Strasbourg, 67081
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Toulouse, 31059
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Kutaisi, 4600
Georgia
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Tbilisi, 0114
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Tbilisi, 0144
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Frankfurt am Main, Hesse 60590
Germany
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Gummersbach, 51643
Germany
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Hamburg, 20246
Germany
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Münster, 48149
Germany
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Gurugram, Haryana 122011
India
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Mangalore, Karnataka 575002
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Nashik, Maharashtra 422005
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New Delhi, National Capital Territory of Delhi 110029
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Ludhiana, Punjab 141001
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Vellore, Tamil Nadu 632 004
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Hyderabad, Telangana 500082
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Lucknow, Uttar Pradesh 226007
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Bergamo, BG 24127
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Orbassano, TO 10043
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Naples, 80131
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Chiba, Chiba 2608677
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Sapporo, Hokkaido 0608543
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Sapporo, Hokkaido 0630005
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Nishinomiya, Hyōgo 6638501
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Hanamaki, Iwate 0250082
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Sendai, Miyagi 9838520
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Suita, Osaka 5650871
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Higashi-Matsuyama, Saitama 355-0005
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Koshigaya, Saitama 343-8555
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Shinjuku Ku, Tokyo 160-0023
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Fukuoka, 8128582
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Fukushima, 9601295
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Hiroshima, 7348551
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Lublin, Lublin Voivodeship 20-064
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Lublin, Lublin Voivodeship 20-080
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Krakow, POL 31-505
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Bydgoszcz, Woj Kujawsko Pomorskie 85-796
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Bydgoszcz, 85-065
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Katowice, 40-689
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Lodz, 93-113
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Lublin, 20-410
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Lublin, 20-701
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Poznan, 61-731
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Rzeszów, 35-323
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Skorzewo, 60-185
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Szczecin, 71-252
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Warsaw, 01-684
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Warsaw, 02-172
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Brasov, 500283
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Bucharest, 040215
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Sibiu, 550245
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Belgrade, 11000
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Niš, 18108
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Novi Sad, 21000
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Seoul, Seoul 03080
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Busan, 49241
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Seoul, 03722
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Seoul, 134 727
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Santiago Compostela, A Coruna 15706
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L'Hospitalet de Llobregat, Barcelona 08907
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Barcelona, 08035
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Lleida, 25198
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Madrid, 28034
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Málaga, 29010
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Valencia, 46026
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Kaohsiung City, 833
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Tainan, 704302
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Taipei, 10002
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Taipei, 111045
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Taoyuan, 33305
Taiwan
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London, NW1 2BU
United Kingdom
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London, SW17 0QT
United Kingdom