Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Remibrutinib in Adults With Generalized Myasthenia Gravis, Followed by an Open-label Extension
Led by Novartis Pharmaceuticals · Updated on 2026-06-01
180
Participants Needed
129
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating remibrutinib compared to a placebo in adults with Generalized Myasthenia Gravis (gMG) who are already receiving stable standard-of-care treatments. This is a Phase III, randomized, double-blind, placebo-controlled study aiming to assess the efficacy, safety, and tolerability of remibrutinib in this patient group. The trial includes about 180 participants and is sponsored by Novartis Pharmaceuticals. Participants will be randomly assigned to one of two groups: one group will receive oral remibrutinib tablets, while the other will receive matching placebo tablets. The study has two parts: a 6-month core period where treatment is blinded, followed by an extension phase lasting up to 60 months where all participants receive open-label remibrutinib. During the study, participants will undergo regular assessments including measurements of daily living activities affected by myasthenia gravis using the MG-ADL scale, muscle strength tests, quality of life questionnaires, and monitoring for adverse events. Researchers will track changes from baseline scores to evaluate treatment effects over time. Safety and tolerability will also be closely monitored throughout both study phases, with total participation lasting up to 66 months.
CONDITIONS
Brief 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...
- Adults aged 18 to 75 years
- Diagnosed with Myasthenia Gravis Foundation of America (MGFA) Class II-IV generalized myasthenia gravis
- 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% due to non-ocular symptoms
- On a stable dose of standard-of-care treatment as specified in the protocol
- Able to safely swallow the study medication based on clinical judgement and swallowing tests
You will not qualify if you...
- Treatment with intravenous immunoglobulins or plasma exchange in the past month before baseline
- Treatment with rituximab in the past 6 months before baseline
- Treatment with eculizumab in the past 2 months before baseline
- Treatment with ravulizumab or other complement inhibitors in the past 3 months before baseline
- Treatment with efgartigimod or other anti-FcRn therapies in the past 3 months before baseline
- Thymectomy in the past 6 months before baseline or planned during the trial
- Women of childbearing potential not using highly effective contraception during dosing and for one week after stopping study treatment
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either remibrutinib or placebo tablets orally during the 6-month double-blind core part of the study.
Visits scheduled throughout the 6-month treatment period
Duration - Up to 60 months
Participants receive open-label remibrutinib tablets orally during the extension part of the study.
Visits scheduled throughout the extension treatment period
Trial Site Locations
Total: 129 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
California Pacific Medical Center
Sacramento, California, United States, 94115
Actively Recruiting
7
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010-2975
Actively Recruiting
8
SFM Clinical Research LLC
Boca Raton, Florida, United States, 33487
Actively Recruiting
9
Homestead Assoc In Research Inc
Homestead, Florida, United States, 33033
Actively Recruiting
10
Neurology Associates PA
Maitland, Florida, United States, 32751
Actively Recruiting
11
AdventHealth
Orlando, Florida, United States, 32804
Actively Recruiting
12
Neurological Services of Orlando PA
Orlando, Florida, United States, 32806
Actively Recruiting
13
University of Chicago Medical Centr
Chicago, Illinois, United States, 60637
Actively Recruiting
14
Mid Atlantic Epilepsy and Sleep Ctr
Bethesda, Maryland, United States, 20817-1807
Actively Recruiting
15
Neuromuscular Diagnostic Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
16
Michigan State University-Department of Neurology
East Lansing, Michigan, United States, 48824
Actively Recruiting
17
Dent Neurological Institute
Buffalo, New York, United States, 14209
Actively Recruiting
18
Univ of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
19
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
20
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
21
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
22
UT Health Science Center
Houston, Texas, United States, 77030
Actively Recruiting
23
University of WA Division of Cardio
Seattle, Washington, United States, 98195
Actively Recruiting
24
Center for Neurological Disorders G
Greenfield, Wisconsin, United States, 53228-1321
Actively Recruiting
25
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
26
Novartis Investigative Site
Caba, Argentina, C1055AAF
Actively Recruiting
27
Novartis Investigative Site
Capital Federal, Argentina, C1023AAB
Actively Recruiting
28
Novartis Investigative Site
San Miguel de Tucumán, Argentina, 4000
Actively Recruiting
29
Novartis Investigative Site
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
30
Novartis Investigative Site
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
31
Novartis Investigative Site
Southport, Australia, 4215
Actively Recruiting
32
Novartis Investigative Site
Leuven, Vlaams Brabant, Belgium, 3000
Actively Recruiting
33
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil, 40050-410
Actively Recruiting
34
Novartis Investigative Site
Brasília, Federal District, Brazil, 70200-730
Actively Recruiting
35
Novartis Investigative Site
Caxias do Sul, Rio Grande do Sul, Brazil, 95070-560
Actively Recruiting
36
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Actively Recruiting
37
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil, 90480-110
Actively Recruiting
38
Novartis Investigative Site
São Paulo, Brazil, 05403-000
Actively Recruiting
39
Novartis Investigative Site
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
40
Novartis Investigative Site
London, Ontario, Canada, N6A 5W9
Actively Recruiting
41
Novartis Investigative Site
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
42
Novartis Investigative Site
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
43
Novartis Investigative Site
Hefei, Anhui, China, 230001
Actively Recruiting
44
Novartis Investigative Site
Guangzhou, Guangdong, China, 510030
Actively Recruiting
45
Novartis Investigative Site
Shijiazhuang, Hebei, China, 50030
Actively Recruiting
46
Novartis Investigative Site
Zhengzhou, Henan, China, 450003
Actively Recruiting
47
Novartis Investigative Site
Wuhan, Hubei, China, 430030
Actively Recruiting
48
Novartis Investigative Site
Wuxi, Jiangsu, China, 214023
Actively Recruiting
49
Novartis Investigative Site
Changchun, Jilin, China, 130021
Actively Recruiting
50
Novartis Investigative Site
Beijing, China, 100034
Actively Recruiting
51
Novartis Investigative Site
Beijing, China, 100730
Actively Recruiting
52
Novartis Investigative Site
Qingdao, China, 266000
Actively Recruiting
53
Novartis Investigative Site
Shanghai, China, 200040
Actively Recruiting
54
Novartis Investigative Site
Shanghai, China, 200080
Actively Recruiting
55
Novartis Investigative Site
Bordeaux, France, 33076
Actively Recruiting
56
Novartis Investigative Site
Nice, France, 06001
Actively Recruiting
57
Novartis Investigative Site
Paris, France, 75013
Actively Recruiting
58
Novartis Investigative Site
Paris, France, 75940
Actively Recruiting
59
Novartis Investigative Site
Strasbourg, France, 67081
Actively Recruiting
60
Novartis Investigative Site
Toulouse, France, 31059
Actively Recruiting
61
Novartis Investigative Site
Kutaisi, Georgia, 4600
Actively Recruiting
62
Novartis Investigative Site
Tbilisi, Georgia, 0114
Actively Recruiting
63
Novartis Investigative Site
Tbilisi, Georgia, 0144
Actively Recruiting
64
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany, 60590
Actively Recruiting
65
Novartis Investigative Site
Gummersbach, Germany, 51643
Actively Recruiting
66
Novartis Investigative Site
Hamburg, Germany, 20246
Actively Recruiting
67
Novartis Investigative Site
Münster, Germany, 48149
Actively Recruiting
68
Novartis Investigative Site
Gurugram, Haryana, India, 122011
Actively Recruiting
69
Novartis Investigative Site
Mangalore, Karnataka, India, 575002
Actively Recruiting
70
Novartis Investigative Site
Nashik, Maharashtra, India, 422005
Actively Recruiting
71
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India, 110029
Actively Recruiting
72
Novartis Investigative Site
Ludhiana, Punjab, India, 141001
Actively Recruiting
73
Novartis Investigative Site
Vellore, Tamil Nadu, India, 632 004
Actively Recruiting
74
Novartis Investigative Site
Hyderabad, Telangana, India, 500082
Actively Recruiting
75
Novartis Investigative Site
Lucknow, Uttar Pradesh, India, 226007
Actively Recruiting
76
Novartis Investigative Site
Bergamo, BG, Italy, 24127
Actively Recruiting
77
Novartis Investigative Site
Orbassano, TO, Italy, 10043
Actively Recruiting
78
Novartis Investigative Site
Naples, Italy, 80131
Actively Recruiting
79
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 0608543
Actively Recruiting
80
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 0630005
Actively Recruiting
81
Novartis Investigative Site
Nishinomiya, Hyōgo, Japan, 6638501
Actively Recruiting
82
Novartis Investigative Site
Hanamaki, Iwate, Japan, 0250082
Actively Recruiting
83
Novartis Investigative Site
Sendai, Miyagi, Japan, 9838520
Actively Recruiting
84
Novartis Investigative Site
Suita, Osaka, Japan, 565-0871
Actively Recruiting
85
Novartis Investigative Site
Higashi-Matsuyama, Saitama, Japan, 355-0005
Actively Recruiting
86
Novartis Investigative Site
Koshigaya, Saitama, Japan, 343-8555
Actively Recruiting
87
Novartis Investigative Site
Shinjuku Ku, Tokyo, Japan, 160-0023
Actively Recruiting
88
Novartis Investigative Site
Chiba, Japan, 2608677
Actively Recruiting
89
Novartis Investigative Site
Fukuoka, Japan, 8128582
Actively Recruiting
90
Novartis Investigative Site
Fukushima, Japan, 9601295
Actively Recruiting
91
Novartis Investigative Site
Hiroshima, Japan, 7348551
Actively Recruiting
92
Novartis Investigative Site
Lublin, Lublin Voivodeship, Poland, 20-064
Actively Recruiting
93
Novartis Investigative Site
Lublin, Lublin Voivodeship, Poland, 20-080
Actively Recruiting
94
Novartis Investigative Site
Krakow, POL, Poland, 31-505
Actively Recruiting
95
Novartis Investigative Site
Bydgoszcz, Woj Kujawsko Pomorskie, Poland, 85-796
Actively Recruiting
96
Novartis Investigative Site
Bydgoszcz, Poland, 85-065
Actively Recruiting
97
Novartis Investigative Site
Katowice, Poland, 40-689
Actively Recruiting
98
Novartis Investigative Site
Lodz, Poland, 93-113
Actively Recruiting
99
Novartis Investigative Site
Lublin, Poland, 20-410
Actively Recruiting
100
Novartis Investigative Site
Lublin, Poland, 20-701
Actively Recruiting
101
Novartis Investigative Site
Poznan, Poland, 61-731
Actively Recruiting
102
Novartis Investigative Site
Rzeszów, Poland, 35-323
Actively Recruiting
103
Novartis Investigative Site
Skorzewo, Poland, 60-185
Actively Recruiting
104
Novartis Investigative Site
Szczecin, Poland, 71-252
Actively Recruiting
105
Novartis Investigative Site
Warsaw, Poland, 01-684
Actively Recruiting
106
Novartis Investigative Site
Warsaw, Poland, 02-172
Actively Recruiting
107
Novartis Investigative Site
Brasov, Romania, 500283
Actively Recruiting
108
Novartis Investigative Site
Bucharest, Romania, 040215
Actively Recruiting
109
Novartis Investigative Site
Sibiu, Romania, 550245
Actively Recruiting
110
Novartis Investigative Site
Belgrade, Serbia, 11000
Actively Recruiting
111
Novartis Investigative Site
Niš, Serbia, 18108
Actively Recruiting
112
Novartis Investigative Site
Novi Sad, Serbia, 21000
Actively Recruiting
113
Novartis Investigative Site
Busan, South Korea, 49241
Actively Recruiting
114
Novartis Investigative Site
Seoul, South Korea, 03080
Actively Recruiting
115
Novartis Investigative Site
Seoul, South Korea, 03722
Actively Recruiting
116
Novartis Investigative Site
Seoul, South Korea, 134 727
Actively Recruiting
117
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain, 15706
Actively Recruiting
118
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
119
Novartis Investigative Site
Barcelona, Spain, 08035
Actively Recruiting
120
Novartis Investigative Site
Lleida, Spain, 25198
Actively Recruiting
121
Novartis Investigative Site
Madrid, Spain, 28034
Actively Recruiting
122
Novartis Investigative Site
Málaga, Spain, 29010
Actively Recruiting
123
Novartis Investigative Site
Valencia, Spain, 46026
Actively Recruiting
124
Novartis Investigative Site
Kaohsiung City, Taiwan, 83301
Actively Recruiting
125
Novartis Investigative Site
Tainan, Taiwan, 704302
Actively Recruiting
126
Novartis Investigative Site
Taipei, Taiwan, 10002
Actively Recruiting
127
Novartis Investigative Site
Taipei, Taiwan, 111045
Actively Recruiting
128
Novartis Investigative Site
Taoyuan, Taiwan, 33305
Actively Recruiting
129
Novartis Investigative Site
London, United Kingdom, NW1 2BU
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
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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