Actively Recruiting
A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis
Led by Novartis Pharmaceuticals · Updated on 2026-05-05
180
Participants Needed
100
Research Sites
420 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with generalized Myasthenia Gravis aged 18 to 75 years
- Confirmed diagnosis of Myasthenia Gravis Foundation of America Class II-IV at screening, likely not needing a respirator during the study
- Documented positive serologic test for AChR+ or MuSK+ antibodies, or seronegative for both at screening
- Baseline MG-ADL score of 6 or higher, with at least 50% of the score due to non-ocular symptoms
- On a stable dose of standard-of-care treatment as specified in the protocol
- Able to safely swallow study medication based on a clinical swallowing test at screening and baseline
You will not qualify if you...
- Treatment with intravenous immunoglobulins or plasma exchange within 1 month before baseline
- Treatment with rituximab within 6 months before baseline
- Treatment with eculizumab within 2 months before baseline
- Treatment with ravulizumab or other complement inhibitors within 3 months before baseline
- Treatment with efgartigimod or other anti-FcRn therapies within 3 months before baseline
- Thymectomy performed within 6 months before baseline or planned during the study period
- Women of child-bearing potential not using highly effective contraception during dosing and for 1 week after stopping study treatment
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 100 locations
1
Neuromuscular Research Center
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
Honor Health Research Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
Fullerton Neuro and Headache Ctr
Fullerton, California, United States, 92835
Actively Recruiting
4
University Of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
5
Univ Cali Irvine ALS Neuromuscular
Orange, California, United States, 92868
Actively Recruiting
6
SFM Clinical Research LLC
Boca Raton, Florida, United States, 33487
Actively Recruiting
7
Homestead Assoc In Research Inc
Homestead, Florida, United States, 33033
Actively Recruiting
8
AdventHealth
Orlando, Florida, United States, 32804
Actively Recruiting
9
Neurological Services of Orlando PA
Orlando, Florida, United States, 32806
Actively Recruiting
10
Mid Atlantic Epilepsy and Sleep Ctr
Bethesda, Maryland, United States, 20817-1807
Actively Recruiting
11
Michigan State University-Department of Neurology
East Lansing, Michigan, United States, 48824
Actively Recruiting
12
Dent Neurological Institute
Buffalo, New York, United States, 14209
Actively Recruiting
13
Univ of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
14
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
15
Houston Methodist Hospital
Houston, Texas, United States, 77030
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16
UT Health Science Center
Houston, Texas, United States, 77030
Actively Recruiting
17
University of WA Division of Cardio
Seattle, Washington, United States, 98195
Actively Recruiting
18
Center for Neurological Disorders G
Greenfield, Wisconsin, United States, 53228-1321
Actively Recruiting
19
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina, 2000
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20
Novartis Investigative Site
Caba, Argentina, C1055AAF
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21
Novartis Investigative Site
Capital Federal, Argentina, C1023AAB
Actively Recruiting
22
Novartis Investigative Site
San Miguel de Tucumán, Argentina, 4000
Actively Recruiting
23
Novartis Investigative Site
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
24
Novartis Investigative Site
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
25
Novartis Investigative Site
Southport, Australia, 4215
Actively Recruiting
26
Novartis Investigative Site
Leuven, Vlaams Brabant, Belgium, 3000
Actively Recruiting
27
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil, 40050-410
Actively Recruiting
28
Novartis Investigative Site
London, Ontario, Canada, N6A 5W9
Actively Recruiting
29
Novartis Investigative Site
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
30
Novartis Investigative Site
Hefei, Anhui, China, 230001
Actively Recruiting
31
Novartis Investigative Site
Guangzhou, Guangdong, China, 510030
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32
Novartis Investigative Site
Shijiazhuang, Hebei, China, 50030
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33
Novartis Investigative Site
Wuhan, Hubei, China, 430030
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34
Novartis Investigative Site
Wuxi, Jiangsu, China, 214023
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35
Novartis Investigative Site
Changchun, Jilin, China, 130021
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36
Novartis Investigative Site
Shanghai, China, 200040
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37
Novartis Investigative Site
Shanghai, China, 200080
Actively Recruiting
38
Novartis Investigative Site
Bordeaux, France, 33076
Actively Recruiting
39
Novartis Investigative Site
Nice, France, 06000
Actively Recruiting
40
Novartis Investigative Site
Paris, France, 75013
Actively Recruiting
41
Novartis Investigative Site
Strasbourg, France, 67081
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42
Novartis Investigative Site
Toulouse, France, 31059
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43
Novartis Investigative Site
Kutaisi, Georgia, 4600
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44
Novartis Investigative Site
Tbilisi, Georgia, 0144
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45
Novartis Investigative Site
Tbilisi, Georgia, 114
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46
Novartis Investigative Site
Hamburg, Germany, 20246
Actively Recruiting
47
Novartis Investigative Site
Gurugram, Haryana, India, 122011
Actively Recruiting
48
Novartis Investigative Site
Mangalore, Karnataka, India, 575002
Actively Recruiting
49
Novartis Investigative Site
Nashik, Maharashtra, India, 422005
Actively Recruiting
50
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India, 110029
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51
Novartis Investigative Site
Ludhiana, Punjab, India, 141001
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52
Novartis Investigative Site
Vellore, Tamil Nadu, India, 632 004
Actively Recruiting
53
Novartis Investigative Site
Hyderabad, Telangana, India, 500082
Actively Recruiting
54
Novartis Investigative Site
Lucknow, Uttar Pradesh, India, 226007
Actively Recruiting
55
Novartis Investigative Site
Bergamo, BG, Italy, 24127
Actively Recruiting
56
Novartis Investigative Site
Orbassano, TO, Italy, 10043
Actively Recruiting
57
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 0608543
Actively Recruiting
58
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 0630005
Actively Recruiting
59
Novartis Investigative Site
Nishinomiya, Hyōgo, Japan, 6638501
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60
Novartis Investigative Site
Hanamaki, Iwate, Japan, 0250082
Actively Recruiting
61
Novartis Investigative Site
Sendai, Miyagi, Japan, 9838520
Actively Recruiting
62
Novartis Investigative Site
Suita, Osaka, Japan, 565-0871
Actively Recruiting
63
Novartis Investigative Site
Higashi-Matsuyama, Saitama, Japan, 355-0005
Actively Recruiting
64
Novartis Investigative Site
Koshigaya, Saitama, Japan, 343-8555
Actively Recruiting
65
Novartis Investigative Site
Shinjuku Ku, Tokyo, Japan, 160-0023
Actively Recruiting
66
Novartis Investigative Site
Chiba, Japan, 2608677
Actively Recruiting
67
Novartis Investigative Site
Fukushima, Japan, 9601295
Actively Recruiting
68
Novartis Investigative Site
Hiroshima, Japan, 7348551
Actively Recruiting
69
Novartis Investigative Site
Lublin, Lublin Voivodeship, Poland, 20-064
Actively Recruiting
70
Novartis Investigative Site
Lublin, Lublin Voivodeship, Poland, 20-080
Actively Recruiting
71
Novartis Investigative Site
Krakow, POL, Poland, 31-505
Actively Recruiting
72
Novartis Investigative Site
Bydgoszcz, Woj Kujawsko Pomorskie, Poland, 85-796
Actively Recruiting
73
Novartis Investigative Site
Bydgoszcz, Poland, 85-065
Actively Recruiting
74
Novartis Investigative Site
Katowice, Poland, 40-689
Actively Recruiting
75
Novartis Investigative Site
Lodz, Poland, 93-113
Actively Recruiting
76
Novartis Investigative Site
Lublin, Poland, 20-410
Actively Recruiting
77
Novartis Investigative Site
Lublin, Poland, 20-701
Actively Recruiting
78
Novartis Investigative Site
Poznan, Poland, 61-731
Actively Recruiting
79
Novartis Investigative Site
Skorzewo, Poland, 60-185
Actively Recruiting
80
Novartis Investigative Site
Warsaw, Poland, 01-684
Actively Recruiting
81
Novartis Investigative Site
Warsaw, Poland, 02-172
Actively Recruiting
82
Novartis Investigative Site
Brasov, Romania, 500283
Actively Recruiting
83
Novartis Investigative Site
Bucharest, Romania, 040215
Actively Recruiting
84
Novartis Investigative Site
Sibiu, Romania, 550245
Actively Recruiting
85
Novartis Investigative Site
Belgrade, Serbia, 11000
Actively Recruiting
86
Novartis Investigative Site
Niš, Serbia, 18108
Actively Recruiting
87
Novartis Investigative Site
Busan, South Korea, 49241
Actively Recruiting
88
Novartis Investigative Site
Seoul, South Korea, 03080
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89
Novartis Investigative Site
Seoul, South Korea, 03722
Actively Recruiting
90
Novartis Investigative Site
Seoul, South Korea, 134 727
Actively Recruiting
91
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
92
Novartis Investigative Site
Lleida, Spain, 25198
Actively Recruiting
93
Novartis Investigative Site
Madrid, Spain, 28034
Actively Recruiting
94
Novartis Investigative Site
Málaga, Spain, 29010
Actively Recruiting
95
Novartis Investigative Site
Valencia, Spain, 46026
Actively Recruiting
96
Novartis Investigative Site
Kaohsiung City, Taiwan, 83301
Actively Recruiting
97
Novartis Investigative Site
Tainan, Taiwan, 704302
Actively Recruiting
98
Novartis Investigative Site
Taipei, Taiwan, 10002
Actively Recruiting
99
Novartis Investigative Site
Taipei, Taiwan, 111045
Actively Recruiting
100
Novartis Investigative Site
Taoyuan, Taiwan, 33305
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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