Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT07225504

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

Led by Novartis Pharmaceuticals · Updated on 2026-05-12

1275

Participants Needed

180

Research Sites

424 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)

CONDITIONS

Official Title

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent prior to any assessments
  • Male or female aged 18 to 65 years at screening
  • Diagnosis of secondary progressive multiple sclerosis per 2017 revised McDonald criteria
  • No clinical relapses in the 24 months before screening and randomization
  • Expanded Disability Status Scale (EDSS) score between 3.0 and 6.0 at screening
  • Documented disability progression in the 12 months before screening
Not Eligible

You will not qualify if you...

  • Unable or unwilling to undergo MRI scans (e.g., due to claustrophobia or contraindications like metallic implants or pacemaker)
  • History of significant central nervous system diseases such as stroke, traumatic brain or spinal injury, or neurological disorders mimicking multiple sclerosis
  • Ongoing substance abuse or psychiatric conditions interfering with study compliance
  • History of confirmed progressive multifocal leukoencephalopathy (PML) or symptoms consistent with PML
  • Women of childbearing potential not using highly effective contraception during and for at least 1 week after treatment
  • Significant bleeding risk or coagulation disorders at screening
  • Use of exclusionary medications before screening or randomization as per protocol
  • Other protocol-defined 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: 180 locations

1

Alabama Neurology Associates PC

Birmingham, Alabama, United States, 35209

Actively Recruiting

2

AZ Integrated Neuro and Spine

Phoenix, Arizona, United States, 85037

Actively Recruiting

3

Center for Neurosciences

Tucson, Arizona, United States, 85718

Actively Recruiting

4

Fullerton Neuro and Headache Ctr

Fullerton, California, United States, 92835

Actively Recruiting

5

Regina Berkovich MD PhD Inc

West Hollywood, California, United States, 90048

Actively Recruiting

6

Georgetown University Hospital

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

7

Medstar Washington Hosp Ctr

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

8

Neurology of Central FL Res Ctr

Altamonte Springs, Florida, United States, 32714

Actively Recruiting

9

UF Health Cancer Center

Gainesville, Florida, United States, 32610

Actively Recruiting

10

Homestead Assoc In Research Inc

Homestead, Florida, United States, 33033

Actively Recruiting

11

Neurology Associates PA

Maitland, Florida, United States, 32751

Actively Recruiting

12

Miami NS Ins Baptist Health S FL

Miami, Florida, United States, 33176

Actively Recruiting

13

Aqualane Clinical Research

Naples, Florida, United States, 34105

Actively Recruiting

14

Orlando Health Clinical Trials

Orlando, Florida, United States, 32806

Actively Recruiting

15

Comprehensive Neurology Clinic

Orlando, Florida, United States, 32825

Actively Recruiting

16

Neurology Associates of Ormond Beach

Ormond Beach, Florida, United States, 32174

Actively Recruiting

17

Axiom Brain Health

Tampa, Florida, United States, 33609

Actively Recruiting

18

Joi Life Wellness Group LLC

Smyrna, Georgia, United States, 30080

Actively Recruiting

19

Hawaii Pacific Neuroscience LLC

Honolulu, Hawaii, United States, 96817

Actively Recruiting

20

University of Kansas Hospital

Kansas City, Kansas, United States, 66160

Actively Recruiting

21

Mid Atlantic Epilepsy and Sleep Ctr

Bethesda, Maryland, United States, 20817-1807

Actively Recruiting

22

Neuro Institute of New England P C

Foxborough, Massachusetts, United States, 02035

Actively Recruiting

23

Michigan Institute of Neurological

Farmington Hills, Michigan, United States, 48334

Actively Recruiting

24

University of New Mexico Hospital

Albuquerque, New Mexico, United States, 87106

Actively Recruiting

25

Premier Neurology

Greenville, South Carolina, United States, 29605

Actively Recruiting

26

Neurology Clinic PC

Cordova, Tennessee, United States, 38018

Actively Recruiting

27

Saturn Research Solution

Plano, Texas, United States, 75024

Actively Recruiting

28

Citta Clinical Research

Spokane, Washington, United States, 99202

Actively Recruiting

29

Novartis Investigative Site

Capital Federal, Buenos Aires, Argentina, 1424

Actively Recruiting

30

Novartis Investigative Site

Bombal, Mendoza Province, Argentina, M5500DXO

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31

Novartis Investigative Site

Buenos Aires, Argentina, C1012AAR

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32

Novartis Investigative Site

Caba, Argentina, C1055AAF

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33

Novartis Investigative Site

CABA, Argentina, C1181ACH

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34

Novartis Investigative Site

Caba, Argentina, C1182

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35

Novartis Investigative Site

Caba, Argentina, C1424BYD

Actively Recruiting

36

Novartis Investigative Site

Santiago del Estero, Argentina, 4200

Actively Recruiting

37

Novartis Investigative Site

Kogarah, New South Wales, Australia, 2217

Actively Recruiting

38

Novartis Investigative Site

New Lambton Heights, New South Wales, Australia, 2305

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39

Novartis Investigative Site

Westmead, New South Wales, Australia, 2145

Actively Recruiting

40

Novartis Investigative Site

Clayton, Victoria, Australia, 3168

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41

Novartis Investigative Site

Heidelberg, Victoria, Australia, 3084

Actively Recruiting

42

Novartis Investigative Site

Linz, Austria, 4020

Actively Recruiting

43

Novartis Investigative Site

Vienna, Austria, 1180

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44

Novartis Investigative Site

Pleven, Bulgaria, 5800

Actively Recruiting

45

Novartis Investigative Site

Sofia, Bulgaria, 1113

Actively Recruiting

46

Novartis Investigative Site

Sofia, Bulgaria, 1407

Actively Recruiting

47

Novartis Investigative Site

Sofia, Bulgaria, 1431

Actively Recruiting

48

Novartis Investigative Site

Sofia, Bulgaria, 1510

Actively Recruiting

49

Novartis Investigative Site

Sofia, Bulgaria, 1606

Actively Recruiting

50

Novartis Investigative Site

Vancouver, British Columbia, Canada, V6T 2A1

Actively Recruiting

51

Novartis Investigative Site

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

52

Novartis Investigative Site

Lévis, Quebec, Canada, G6W 0M5

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53

Novartis Investigative Site

Montreal, Quebec, Canada, H2W 1T8

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54

Novartis Investigative Site

Montreal, Quebec, Canada, H3A 2B4

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55

Novartis Investigative Site

Montreal, Quebec, Canada, H4A 3T2

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56

Novartis Investigative Site

Sherbrooke, Quebec, Canada, J1H 5N4

Actively Recruiting

57

Novartis Investigative Site

Guangzhou, Guangdong, China, 510030

Actively Recruiting

58

Novartis Investigative Site

Zhengzhou, Henan, China, 450003

Actively Recruiting

59

Novartis Investigative Site

Wuhan, Hubei, China, 430030

Actively Recruiting

60

Novartis Investigative Site

Hohhot, Inner Mongolia, China, 010017

Actively Recruiting

61

Novartis Investigative Site

Suzhou, Jiangsu, China, 215004

Actively Recruiting

62

Novartis Investigative Site

Changchun, Jilin, China, 130021

Actively Recruiting

63

Novartis Investigative Site

Yinchuan, Ningxia, China, 750004

Actively Recruiting

64

Novartis Investigative Site

Xianyang, Shaanxi, China, 712000

Actively Recruiting

65

Novartis Investigative Site

Taiyuan, Shanxi, China, 030001

Actively Recruiting

66

Novartis Investigative Site

Hangzhou, Zhejiang, China, 310016

Actively Recruiting

67

Novartis Investigative Site

Wenzhou, Zhejiang, China, 325000

Actively Recruiting

68

Novartis Investigative Site

Beijing, China, 065001

Actively Recruiting

69

Novartis Investigative Site

Beijing, China, 100034

Actively Recruiting

70

Novartis Investigative Site

Chongqing, China, 400016

Actively Recruiting

71

Novartis Investigative Site

Shanghai, China, 200040

Actively Recruiting

72

Novartis Investigative Site

Tianjin, China, 300052

Actively Recruiting

73

Novartis Investigative Site

Barranquilla, Atlántico, Colombia, 080020

Actively Recruiting

74

Novartis Investigative Site

Bogotá, Colombia, 111321

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75

Novartis Investigative Site

Medellín, Colombia, 050001

Actively Recruiting

76

Novartis Investigative Site

Medellín, Colombia, 050034

Actively Recruiting

77

Novartis Investigative Site

Jihlava, Czechia, 586 01

Actively Recruiting

78

Novartis Investigative Site

Prague, Czechia, 140 59

Actively Recruiting

79

Novartis Investigative Site

Prague, Czechia, 150 06

Actively Recruiting

80

Novartis Investigative Site

Teplice, Czechia, 415 29

Actively Recruiting

81

Novartis Investigative Site

Esbjerg, Denmark, 6700

Actively Recruiting

82

Novartis Investigative Site

Limoges, Haute Vienne, France, 87000

Actively Recruiting

83

Novartis Investigative Site

Ajaccio, France, 20090

Actively Recruiting

84

Novartis Investigative Site

Amiens, France, 80054

Actively Recruiting

85

Novartis Investigative Site

Clermont-Ferrand, France, 63003

Actively Recruiting

86

Novartis Investigative Site

Gonesse, France, 95500

Actively Recruiting

87

Novartis Investigative Site

Grenoble, France, 38043

Actively Recruiting

88

Novartis Investigative Site

Lille, France, 59000

Actively Recruiting

89

Novartis Investigative Site

Lille, France, 59037

Actively Recruiting

90

Novartis Investigative Site

Montpellier, France, 34090

Actively Recruiting

91

Novartis Investigative Site

Nancy, France, 54035

Actively Recruiting

92

Novartis Investigative Site

Nice, France, 06000

Actively Recruiting

93

Novartis Investigative Site

Nîmes, France, 30029

Actively Recruiting

94

Novartis Investigative Site

Orsay, France, 91400

Actively Recruiting

95

Novartis Investigative Site

Paris, France, 75013

Actively Recruiting

96

Novartis Investigative Site

Paris, France, 75940

Actively Recruiting

97

Novartis Investigative Site

Poitiers, France, 86021

Actively Recruiting

98

Novartis Investigative Site

Rennes, France, 35033

Actively Recruiting

99

Novartis Investigative Site

Rouen, France, 76031

Actively Recruiting

100

Novartis Investigative Site

Strasbourg, France, 67000

Actively Recruiting

101

Novartis Investigative Site

Toulouse, France, 31059

Actively Recruiting

102

Novartis Investigative Site

Tours, France, 37044

Actively Recruiting

103

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106

Actively Recruiting

104

Novartis Investigative Site

Mannheim, Baden-Wurttemberg, Germany, 68167

Actively Recruiting

105

Novartis Investigative Site

Munich, Bavaria, Germany, 81377

Actively Recruiting

106

Novartis Investigative Site

Unterhaching, Bavaria, Germany, 82008

Actively Recruiting

107

Novartis Investigative Site

Halle, Saxony-Anhalt, Germany, 06120

Actively Recruiting

108

Novartis Investigative Site

Erfurt, Germany, 99089

Actively Recruiting

109

Novartis Investigative Site

Giessen, Germany, 35392

Actively Recruiting

110

Novartis Investigative Site

Greifswald, Germany, 17475

Actively Recruiting

111

Novartis Investigative Site

Heidelberg, Germany, 69120

Actively Recruiting

112

Novartis Investigative Site

Itzehoe, Germany, 25524

Actively Recruiting

113

Novartis Investigative Site

Tübingen, Germany, 72076

Actively Recruiting

114

Novartis Investigative Site

Chaïdári, Greece, 124 62

Actively Recruiting

115

Novartis Investigative Site

Budapest, Hungary, 1044

Actively Recruiting

116

Novartis Investigative Site

Kistarcsa, Hungary, 2143

Actively Recruiting

117

Novartis Investigative Site

Gurugram, Haryana, India, 122011

Actively Recruiting

118

Novartis Investigative Site

Mangalore, Karnataka, India, 575003

Actively Recruiting

119

Novartis Investigative Site

Kochi, Kerala, India, 682025

Actively Recruiting

120

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, India, 110029

Actively Recruiting

121

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, India, 110060

Actively Recruiting

122

Novartis Investigative Site

Chandigarh, Punjab, India, 160012

Actively Recruiting

123

Novartis Investigative Site

Vellore, Tamil Nadu, India, 632 004

Actively Recruiting

124

Novartis Investigative Site

Hyderabad, Telangana, India, 500082

Actively Recruiting

125

Novartis Investigative Site

Haifa, Israel, 3436212

Actively Recruiting

126

Novartis Investigative Site

Jerusalem, Israel, 9112001

Actively Recruiting

127

Novartis Investigative Site

Ramat Gan, Israel, 5265601

Actively Recruiting

128

Novartis Investigative Site

Rehovot, Israel, 7661041

Actively Recruiting

129

Novartis Investigative Site

Tel Aviv, Israel, 6423906

Actively Recruiting

130

Novartis Investigative Site

Ẕerifin, Israel, 7030000

Actively Recruiting

131

Novartis Investigative Site

Bergamo, BG, Italy, 24127

Actively Recruiting

132

Novartis Investigative Site

Foggia, FG, Italy, 71122

Actively Recruiting

133

Novartis Investigative Site

Pozzilli, IS, Italy, 86077

Actively Recruiting

134

Novartis Investigative Site

Pavia, PV, Italy, 27100

Actively Recruiting

135

Novartis Investigative Site

Roma, RM, Italy, 00133

Actively Recruiting

136

Novartis Investigative Site

Arnhem, Gelderland, Netherlands, 6815 AD

Actively Recruiting

137

Novartis Investigative Site

Leiden, Netherlands, 2334 CN

Actively Recruiting

138

Novartis Investigative Site

Bydgoszcz, Woj Kujawsko Pomorskie, Poland, 85-796

Actively Recruiting

139

Novartis Investigative Site

Chojnice, Poland, 89-600

Actively Recruiting

140

Novartis Investigative Site

Katowice, Poland, 40-081

Actively Recruiting

141

Novartis Investigative Site

Katowice, Poland, 40-686

Actively Recruiting

142

Novartis Investigative Site

Rzeszów, Poland, 35-323

Actively Recruiting

143

Novartis Investigative Site

Skorzewo, Poland, 60-185

Actively Recruiting

144

Novartis Investigative Site

Zabrze, Poland, 41-800

Actively Recruiting

145

Novartis Investigative Site

Żory, Poland, 44-240

Actively Recruiting

146

Novartis Investigative Site

Braga, Portugal, 4710243

Actively Recruiting

147

Novartis Investigative Site

Lisbon, Portugal, 1349-019

Actively Recruiting

148

Novartis Investigative Site

Porto, Portugal, 4200 319

Actively Recruiting

149

Novartis Investigative Site

Constanța, ROM, Romania, 900123

Actively Recruiting

150

Novartis Investigative Site

Bucharest, Romania, 040215

Actively Recruiting

151

Novartis Investigative Site

Campulung Muscel, Romania, 115100

Actively Recruiting

152

Novartis Investigative Site

Bratislava, Slovakia, 851 01

Actively Recruiting

153

Novartis Investigative Site

Komárno, Slovakia, 945 05

Actively Recruiting

154

Novartis Investigative Site

Nitra, Slovakia, 950 01

Actively Recruiting

155

Novartis Investigative Site

Trnava, Slovakia, 917 02

Actively Recruiting

156

Novartis Investigative Site

Cape Town, Western Cape, South Africa, 7405

Actively Recruiting

157

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, Spain, 08907

Actively Recruiting

158

Novartis Investigative Site

Pozuelo de Alarcón, Madrid, Spain, 28223

Actively Recruiting

159

Novartis Investigative Site

Torrejón de Ardoz, Madrid, Spain, 28850

Actively Recruiting

160

Novartis Investigative Site

El Palmar, Murcia, Spain, 30120

Actively Recruiting

161

Novartis Investigative Site

Castilleja de la Cuesta, Sevilla, Spain, 41950

Actively Recruiting

162

Novartis Investigative Site

Valencia, Valencia, Spain, 46017

Actively Recruiting

163

Novartis Investigative Site

Barakaldo, Vizcaya, Spain, 48903

Actively Recruiting

164

Novartis Investigative Site

Alicante, Spain, 03010

Actively Recruiting

165

Novartis Investigative Site

Barcelona, Spain, 08035

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166

Novartis Investigative Site

Las Palmas GC, Spain, 35010

Actively Recruiting

167

Novartis Investigative Site

Lleida, Spain, 25198

Actively Recruiting

168

Novartis Investigative Site

Madrid, Spain, 28009

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169

Novartis Investigative Site

Madrid, Spain, 28034

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170

Novartis Investigative Site

Madrid, Spain, 28040

Actively Recruiting

171

Novartis Investigative Site

Málaga, Spain, 29010

Actively Recruiting

172

Novartis Investigative Site

Salamanca, Spain, 37007

Actively Recruiting

173

Novartis Investigative Site

Valencia, Spain, 46026

Actively Recruiting

174

Novartis Investigative Site

Bern, Switzerland, 3010

Actively Recruiting

175

Novartis Investigative Site

Lausanne, Switzerland, 1011

Actively Recruiting

176

Novartis Investigative Site

Brighton, East Sussex, United Kingdom, BN2 5BE

Actively Recruiting

177

Novartis Investigative Site

Coventry, United Kingdom, CV2 2DX

Actively Recruiting

178

Novartis Investigative Site

Glasgow, United Kingdom, G51 4TF

Actively Recruiting

179

Novartis Investigative Site

Leeds, United Kingdom, LS1 3EX

Actively Recruiting

180

Novartis Investigative Site

Nottingham, United Kingdom, NG7 2UH

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

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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