Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06744920

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

Actively Recruiting

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

Actively Recruiting

20

Novartis Investigative Site

Caba, Argentina, C1055AAF

Actively Recruiting

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

Actively Recruiting

32

Novartis Investigative Site

Shijiazhuang, Hebei, China, 50030

Actively Recruiting

33

Novartis Investigative Site

Wuhan, Hubei, China, 430030

Actively Recruiting

34

Novartis Investigative Site

Wuxi, Jiangsu, China, 214023

Actively Recruiting

35

Novartis Investigative Site

Changchun, Jilin, China, 130021

Actively Recruiting

36

Novartis Investigative Site

Shanghai, China, 200040

Actively Recruiting

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

Actively Recruiting

42

Novartis Investigative Site

Toulouse, France, 31059

Actively Recruiting

43

Novartis Investigative Site

Kutaisi, Georgia, 4600

Actively Recruiting

44

Novartis Investigative Site

Tbilisi, Georgia, 0144

Actively Recruiting

45

Novartis Investigative Site

Tbilisi, Georgia, 114

Actively Recruiting

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

Actively Recruiting

51

Novartis Investigative Site

Ludhiana, Punjab, India, 141001

Actively Recruiting

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

Actively Recruiting

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

Actively Recruiting

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

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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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