Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06858579

A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)

Led by Dianthus Therapeutics · Updated on 2026-05-13

256

Participants Needed

167

Research Sites

307 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).

CONDITIONS

Official Title

A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must have given written informed consent before any study-related activities
  • Weight between 40 kg and 120 kg
  • Confirmed diagnosis of typical or variant CIDP (motor or multifocal) confirmed by Independent CIDP Review Panel
  • CIDP Disease Activity Status (CDAS) score of 3 or higher at screening
  • Neurologically stable
  • INCAT score between 2 and 9 inclusive
  • Must meet one treatment condition: currently treated and responded to immunoglobulin (IVIg or SCIg) alone or with corticosteroids; or currently treated and responded to corticosteroids alone or with azathioprine or mycophenolate mofetil; or refractory with inadequate response or intolerance to these treatments; or treatment-naive with no prior CIDP treatment
  • Documented vaccinations against encapsulated bacteria as per local requirements
  • Female participants must be nonchildbearing or agree to use highly effective contraception and not donate ova
  • Male participants must agree not to donate sperm and use acceptable contraception or be surgically sterile for 90 days before screening
Not Eligible

You will not qualify if you...

  • Signs or symptoms of polyneuropathy from causes other than CIDP
  • Known central demyelination or history of myelopathy
  • Significant medical or surgical condition including acute illness or major surgery affecting safety or study procedures
  • Any other condition or prior therapy making participant unsuitable
  • Known complement deficiency or positive anti-C1 antibodies
  • Diagnosis or family history of systemic lupus erythematosus (SLE)
  • Autoimmune diseases affecting joints, muscles, or nervous system
  • Coexisting conditions interfering with outcomes such as severe diabetic neuropathy, fibromyalgia, inflammatory arthritis, or osteoarthritis of hands and feet
  • Prior history of Neisseria meningitidis infection
  • Active malignancy within 5 years except certain skin or low-grade prostate cancers under observation
  • Positive tests for active HIV, hepatitis B, or hepatitis C infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 167 locations

1

Clinical Study Site

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

Clinical Study Site

Phoenix, Arizona, United States, 85028

Actively Recruiting

3

Clinical Study Site

Scottsdale, Arizona, United States, 85251'

Actively Recruiting

4

Clinical Study Site

Los Angeles, California, United States, 90048

Actively Recruiting

5

Clinical Study Site

San Francisco, California, United States, 94109

Actively Recruiting

6

Clinical Study Site

San Francisco, California, United States, 94158

Actively Recruiting

7

Clinical Study Site

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

Actively Recruiting

8

Clinical Study Site

Maitland, Florida, United States, 32751

Actively Recruiting

9

Clinical Study Site

Tampa, Florida, United States, 33620

Actively Recruiting

10

Clinical Study Site

Honolulu, Hawaii, United States, 96817

Actively Recruiting

11

Clinical Study Site

Chicago, Illinois, United States, 60611

Actively Recruiting

12

Clinical Study Site

Edwardsville, Illinois, United States, 62025

Actively Recruiting

13

Clinical Study Site

Indianapolis, Indiana, United States, 46202

Actively Recruiting

14

Clinical Study Site

Kansas City, Kansas, United States, 66160

Actively Recruiting

15

Clinical Study Site

Burlington, Massachusetts, United States, 01805

Actively Recruiting

16

Clinical Study Site

East Lansing, Michigan, United States, 48824

Actively Recruiting

17

Clinical Study Site

Omaha, Nebraska, United States, 68198

Actively Recruiting

18

Cinical Study Site

Lebanon, New Hampshire, United States, 03766

Actively Recruiting

19

Clinical Study Site

New York, New York, United States, 10021

Actively Recruiting

20

Clinical Study Site

New York, New York, United States, 10032

Actively Recruiting

21

Clinical Study Site

Cincinnati, Ohio, United States, 45219

Actively Recruiting

22

Clinical Study Site

Columbus, Ohio, United States, 43221

Actively Recruiting

23

Clinical Study Site

Portland, Oregon, United States, 97239

Actively Recruiting

24

Cinical Study Site

Nashville, Tennessee, United States, 37232

Actively Recruiting

25

Clinical Study Site

Dallas, Texas, United States, 75243

Actively Recruiting

26

Clinical Study Site

Denton, Texas, United States, 76208

Actively Recruiting

27

Cinical Study Site

Houston, Texas, United States, 77030

Actively Recruiting

28

Texas Locations

Houston, Texas, United States, 77054

Actively Recruiting

29

Clinical Study Site

Round Rock, Texas, United States, 78681

Actively Recruiting

30

Clinical Study Site

Sugar Land, Texas, United States, 77478

Actively Recruiting

31

Clinical Study Site

Seattle, Washington, United States, 98195

Actively Recruiting

32

Cinical Study Site

Buenos Aires, Buenos Aires, Argentina

Actively Recruiting

33

Cinical Study Site

Rosario, Santa Fe Province, Argentina

Actively Recruiting

34

Cinical Study Site #3

Buenos Aires, Argentina

Actively Recruiting

35

Cinical Study Site #4

Buenos Aires, Argentina

Actively Recruiting

36

Clinical Study Site #2

Buenos Aires, Argentina

Actively Recruiting

37

Clinical Study Site

Buenos Aires, Argentina

Actively Recruiting

38

Cinical Study Site #2

San Miguel de Tucumán, Argentina

Actively Recruiting

39

Clinical Study Site

San Miguel de Tucumán, Argentina

Actively Recruiting

40

Cinical Study Site

Liverpool, New South Wales, Australia

Actively Recruiting

41

Clinical Study Site

Randwick, New South Wales, Australia, 2031

Actively Recruiting

42

Cinical Study Site

Saint Leonards, New South Wales, Australia, 2065

Actively Recruiting

43

Cinical Study Site

Sydney, New South Wales, Australia, 2033

Actively Recruiting

44

Cinical Study Site

Southport, Queensland, Australia, 4215

Actively Recruiting

45

Clinical Study Site

Melbourne, Victoria, Australia, 3004

Actively Recruiting

46

Cinical Study Site

Anderlecht, Brussels Capital, Belgium

Actively Recruiting

47

Cinical Study Site

Brussels, Belgium

Actively Recruiting

48

Cinical Study Site

Rio de Janeiro, Rio de Janeiro, Brazil, 20551-030

Actively Recruiting

49

Clinical Study Site

Campinas, São Paulo, Brazil

Actively Recruiting

50

Cinical Study Site

Natal, Brazil

Actively Recruiting

51

Cinical Study Site

Porto Alegre, Brazil, 90610-000

Actively Recruiting

52

Cinical Study Site

Salvador, Brazil, 40290-000

Actively Recruiting

53

Cinical Study Site

São Paulo, Brazil, 04038

Actively Recruiting

54

Cinical Study Site

São Paulo, Brazil, 05403-000

Actively Recruiting

55

Cinical Study Site

Sofia, Bulgaria

Actively Recruiting

56

Clinical Study Site

Sofia, Bulgaria

Actively Recruiting

57

Clinical Study Site

Hefei, Anhui, China, 230001

Actively Recruiting

58

Clinical Study Site

Guangzhou, Guangdong, China, 510080

Actively Recruiting

59

Clinical Study Site

Changsha, Hu'Nan, China, 410008

Actively Recruiting

60

Clinical Study Site

Changsha, Hu'Nan, China, 410013

Actively Recruiting

61

Clinical Study Site

Wuhan, Hubei, China, 430060

Actively Recruiting

62

Clinical Study Site

Chifeng, Inner Mongolia, China, 024050

Actively Recruiting

63

Clinical Study Site

Suzhou, Jiangsu, China, 215006

Actively Recruiting

64

Clinical Study Site

Beijing, China, 100034

Actively Recruiting

65

Clinical Study Site

Beijing, China, 100191

Actively Recruiting

66

Clinical Study Site

Chengdu, China, 610072

Actively Recruiting

67

Clinical Study Site

Fujian, China, 350001

Actively Recruiting

68

Clinical Study Site

Guangdong, China, 510180

Actively Recruiting

69

Clinical Study Site

Guangzhou, China, 510515

Actively Recruiting

70

Clinical Study Site

Jilin, China, 130021

Actively Recruiting

71

Clinical Study Site

Shanghai, China, 200031

Actively Recruiting

72

Clinical Study Site

Shanghai, China, 200040

Actively Recruiting

73

Clinical Study Site

Sichuan, China, 610072

Actively Recruiting

74

Clinical Study Site

Taiyuan, China

Actively Recruiting

75

Clinical Study Site

Wuhan, China

Actively Recruiting

76

Cinical Study Site

Medellín, Antioquia, Colombia

Actively Recruiting

77

Cinical Study Site

Antioquia, Colombia

Actively Recruiting

78

Cinical Study Site

Medellín, Colombia

Actively Recruiting

79

Cinical Study Site

Osijek, Croatia

Actively Recruiting

80

Clinical Study Site

Aarhus, Denmark, 8200

Actively Recruiting

81

Clinical Study Site

Copenhagen, Denmark

Actively Recruiting

82

Clinical Study Site

Bordeaux, France, 33000

Actively Recruiting

83

Cinical Study Site

Brest, France, 29200

Actively Recruiting

84

Clinical Study Site

Bron, France, 69500

Actively Recruiting

85

Clinical Study Site

Clermont-Ferrand, France, 63000

Actively Recruiting

86

Clinical Study Site

Libourne, France, 33500

Actively Recruiting

87

Clinical Study Site

Marseille, France, 13005

Actively Recruiting

88

Clinical Study Site

Nice, France, 06000

Actively Recruiting

89

Clinical Study Site

Paris, France, 75013

Actively Recruiting

90

Clinical Study Site

Paris, France, 75610

Actively Recruiting

91

Clinical Study Site

Strasbourg, France, 67200

Actively Recruiting

92

Cinical Study Site

Tours, France, 37000

Actively Recruiting

93

Clinical Study Site

Tours, France, 37000

Actively Recruiting

94

Clinical Study Site

Tbilisi, Georgia

Actively Recruiting

95

Cinical Study Site

München, Bavaria, Germany

Actively Recruiting

96

Clinical Study Site

Sande, Lower Saxony, Germany, 26452

Actively Recruiting

97

Clinical Study Site

Aachen, Germany, 52074

Actively Recruiting

98

Cinical Study Site

Greifswald, Germany, 17489

Actively Recruiting

99

Clinical Study Site

Rüdersdorf, Germany, 15562

Actively Recruiting

100

Clinical Study Site

Sande, Germany, 26452

Actively Recruiting

101

Cinical Study Site

Beersheba, Israel

Actively Recruiting

102

Cinical Study Site

Haifa, Israel, 3109601

Actively Recruiting

103

Cinical Study Site

Safed, Israel

Actively Recruiting

104

Clinical Study Site

Bergamo, Italy, 24127

Actively Recruiting

105

Clinical Study Site

Bologna, Italy, 40139

Actively Recruiting

106

Cinical Study Site

Genova, Italy, 16132

Actively Recruiting

107

Cinical Study Site

Gussago, Italy, 25064

Actively Recruiting

108

Cinical Study Site

Milan, Italy, 20126

Actively Recruiting

109

Cinical Study Site

Milan, Italy

Actively Recruiting

110

Cinical Study Site

Modena, Italy

Actively Recruiting

111

Clinical Study Site

Pavia, Italy, 27100

Actively Recruiting

112

Clinical Study Site

Ponderano, Italy, 13875

Actively Recruiting

113

Clinical Study Site

Roma, Italy, 00128

Actively Recruiting

114

Cinical Study Site

Roma, Italy, 00133

Actively Recruiting

115

Clinical Study Site #2

Roma, Italy, 00189

Actively Recruiting

116

Clinical Study Site

Roma, Italy

Actively Recruiting

117

Cinical Study Site

Terni, Italy

Actively Recruiting

118

Cinical Study Site

Riga, Latvia, LV-1002

Actively Recruiting

119

Clinical Study Site

Riga, Latvia, LV-1024

Actively Recruiting

120

Cinical Study Site

Kota Kinabalu, Sabah, Malaysia

Actively Recruiting

121

Cinical Study Site

Kuching, Sarawak, Malaysia

Actively Recruiting

122

Cinical Study Site

George Town, Malaysia, 11700

Actively Recruiting

123

Cinical Study Site

Johor Bahru, Malaysia, 80100

Actively Recruiting

124

Cinical Study Site

Kota Kinabalu, Malaysia

Actively Recruiting

125

Cinical Study Site

Kuala Lumpur, Malaysia, 50586

Actively Recruiting

126

Cinical Study Site

Kuala Lumpur, Malaysia, 50603

Actively Recruiting

127

Cinical Study Site

Kuala Lumpur, Malaysia, 56000

Actively Recruiting

128

Cinical Study Site

Kuching, Malaysia

Actively Recruiting

129

Cinical Study Site

Sungai Buloh, Malaysia

Actively Recruiting

130

Cinical Study Site

Amsterdam, Netherlands

Actively Recruiting

131

Cinical Study Site

Utrecht, Netherlands

Actively Recruiting

132

Clinical Study Site

Skopje, North Macedonia, 1000

Actively Recruiting

133

Cinical Study Site

Cebu City, Philippines

Actively Recruiting

134

Cinical Study Site

City of Muntinlupa, Philippines

Actively Recruiting

135

Cinical Study Site

Iloilo City, Philippines

Actively Recruiting

136

Clinical Study Site

Bydgoszcz, Poland, 85-090

Actively Recruiting

137

Clinical Study Site

Krakow, Poland, 30-688

Actively Recruiting

138

Clinical Study Site

Lublin, Poland, 20-701

Actively Recruiting

139

Clinical Study Site

Lublin, Poland, 20-718

Actively Recruiting

140

Clinical Study Site

Lublin, Poland, 7763138

Actively Recruiting

141

Cinical Study Site

Warsaw, Poland, 04-141

Actively Recruiting

142

Clinical Study Site

Wroclaw, Poland, 50-367

Actively Recruiting

143

Clinical Study Site

Bucharest, Romania, 050474

Actively Recruiting

144

Cinical Study Site

Târgu Mureş, Romania, 540136

Actively Recruiting

145

Cinical Study Site

Belgrade, Serbia, 11000

Actively Recruiting

146

Clinical Study Site

Belgrade, Serbia, 11000

Actively Recruiting

147

Clinical Study Site

Kragujevac, Serbia, 34000

Actively Recruiting

148

Clinical Study Site

Niš, Serbia, 18000

Actively Recruiting

149

Cinical Study Site

Daegu, South Korea

Actively Recruiting

150

Cinical Study Site

Daejeon, South Korea

Actively Recruiting

151

Cinical Study Site #2

Seoul, South Korea

Actively Recruiting

152

Cinical Study Site #3

Seoul, South Korea

Actively Recruiting

153

Cinical Study Site

Seoul, South Korea

Actively Recruiting

154

Cinical Study Site

Uijeongbu-si, South Korea

Actively Recruiting

155

Cinical Study Site

Yangsan, South Korea

Actively Recruiting

156

Clinical Study Site

Barcelona, Barcelona, Spain, 08916

Actively Recruiting

157

Clinical Study Site

Alicante, Spain, 03010

Actively Recruiting

158

Clinical Study Site

Barcelona, Spain, 08025

Actively Recruiting

159

Cinical Study Site

Barcelona, Spain, 08041

Actively Recruiting

160

Clinical Study Site

Bilbao, Spain, 48013

Actively Recruiting

161

Cinical Study Site #2

Bangkok, Thailand

Actively Recruiting

162

Cinical Study Site

Bangkok, Thailand

Actively Recruiting

163

Cinical Study Site

Hat Yai, Thailand

Actively Recruiting

164

Cinical Study Site

Khlong Luang, Thailand

Actively Recruiting

165

Cinical Study Site

Khon Kaen, Thailand, 40002

Actively Recruiting

166

Cinical Study Site

Khon Kaen, Thailand

Actively Recruiting

167

Clinical Study Site

Oxford, United Kingdom

Actively Recruiting

Loading map...

Research Team

D

Dianthus Clinical Contact Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here