Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 167 locations
1
Clinical Study Site
Birmingham, Alabama, United States, 35294
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2
Clinical Study Site
Phoenix, Arizona, United States, 85028
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3
Clinical Study Site
Scottsdale, Arizona, United States, 85251'
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4
Clinical Study Site
Los Angeles, California, United States, 90048
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5
Clinical Study Site
San Francisco, California, United States, 94109
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6
Clinical Study Site
San Francisco, California, United States, 94158
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7
Clinical Study Site
Washington D.C., District of Columbia, United States, 20007
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8
Clinical Study Site
Maitland, Florida, United States, 32751
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9
Clinical Study Site
Tampa, Florida, United States, 33620
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10
Clinical Study Site
Honolulu, Hawaii, United States, 96817
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11
Clinical Study Site
Chicago, Illinois, United States, 60611
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12
Clinical Study Site
Edwardsville, Illinois, United States, 62025
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13
Clinical Study Site
Indianapolis, Indiana, United States, 46202
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14
Clinical Study Site
Kansas City, Kansas, United States, 66160
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15
Clinical Study Site
Burlington, Massachusetts, United States, 01805
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16
Clinical Study Site
East Lansing, Michigan, United States, 48824
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17
Clinical Study Site
Omaha, Nebraska, United States, 68198
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18
Cinical Study Site
Lebanon, New Hampshire, United States, 03766
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19
Clinical Study Site
New York, New York, United States, 10021
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20
Clinical Study Site
New York, New York, United States, 10032
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21
Clinical Study Site
Cincinnati, Ohio, United States, 45219
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22
Clinical Study Site
Columbus, Ohio, United States, 43221
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23
Clinical Study Site
Portland, Oregon, United States, 97239
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24
Cinical Study Site
Nashville, Tennessee, United States, 37232
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25
Clinical Study Site
Dallas, Texas, United States, 75243
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26
Clinical Study Site
Denton, Texas, United States, 76208
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27
Cinical Study Site
Houston, Texas, United States, 77030
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28
Texas Locations
Houston, Texas, United States, 77054
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29
Clinical Study Site
Round Rock, Texas, United States, 78681
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30
Clinical Study Site
Sugar Land, Texas, United States, 77478
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31
Clinical Study Site
Seattle, Washington, United States, 98195
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32
Cinical Study Site
Buenos Aires, Buenos Aires, Argentina
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33
Cinical Study Site
Rosario, Santa Fe Province, Argentina
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34
Cinical Study Site #3
Buenos Aires, Argentina
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35
Cinical Study Site #4
Buenos Aires, Argentina
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36
Clinical Study Site #2
Buenos Aires, Argentina
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37
Clinical Study Site
Buenos Aires, Argentina
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38
Cinical Study Site #2
San Miguel de Tucumán, Argentina
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39
Clinical Study Site
San Miguel de Tucumán, Argentina
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40
Cinical Study Site
Liverpool, New South Wales, Australia
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41
Clinical Study Site
Randwick, New South Wales, Australia, 2031
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42
Cinical Study Site
Saint Leonards, New South Wales, Australia, 2065
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43
Cinical Study Site
Sydney, New South Wales, Australia, 2033
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44
Cinical Study Site
Southport, Queensland, Australia, 4215
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45
Clinical Study Site
Melbourne, Victoria, Australia, 3004
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46
Cinical Study Site
Anderlecht, Brussels Capital, Belgium
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47
Cinical Study Site
Brussels, Belgium
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48
Cinical Study Site
Rio de Janeiro, Rio de Janeiro, Brazil, 20551-030
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49
Clinical Study Site
Campinas, São Paulo, Brazil
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50
Cinical Study Site
Natal, Brazil
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51
Cinical Study Site
Porto Alegre, Brazil, 90610-000
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52
Cinical Study Site
Salvador, Brazil, 40290-000
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53
Cinical Study Site
São Paulo, Brazil, 04038
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54
Cinical Study Site
São Paulo, Brazil, 05403-000
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55
Cinical Study Site
Sofia, Bulgaria
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56
Clinical Study Site
Sofia, Bulgaria
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57
Clinical Study Site
Hefei, Anhui, China, 230001
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58
Clinical Study Site
Guangzhou, Guangdong, China, 510080
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59
Clinical Study Site
Changsha, Hu'Nan, China, 410008
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60
Clinical Study Site
Changsha, Hu'Nan, China, 410013
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61
Clinical Study Site
Wuhan, Hubei, China, 430060
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62
Clinical Study Site
Chifeng, Inner Mongolia, China, 024050
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63
Clinical Study Site
Suzhou, Jiangsu, China, 215006
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64
Clinical Study Site
Beijing, China, 100034
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65
Clinical Study Site
Beijing, China, 100191
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66
Clinical Study Site
Chengdu, China, 610072
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67
Clinical Study Site
Fujian, China, 350001
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68
Clinical Study Site
Guangdong, China, 510180
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69
Clinical Study Site
Guangzhou, China, 510515
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70
Clinical Study Site
Jilin, China, 130021
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71
Clinical Study Site
Shanghai, China, 200031
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72
Clinical Study Site
Shanghai, China, 200040
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73
Clinical Study Site
Sichuan, China, 610072
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74
Clinical Study Site
Taiyuan, China
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75
Clinical Study Site
Wuhan, China
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76
Cinical Study Site
Medellín, Antioquia, Colombia
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77
Cinical Study Site
Antioquia, Colombia
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78
Cinical Study Site
Medellín, Colombia
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79
Cinical Study Site
Osijek, Croatia
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80
Clinical Study Site
Aarhus, Denmark, 8200
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81
Clinical Study Site
Copenhagen, Denmark
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82
Clinical Study Site
Bordeaux, France, 33000
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83
Cinical Study Site
Brest, France, 29200
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84
Clinical Study Site
Bron, France, 69500
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85
Clinical Study Site
Clermont-Ferrand, France, 63000
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86
Clinical Study Site
Libourne, France, 33500
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87
Clinical Study Site
Marseille, France, 13005
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88
Clinical Study Site
Nice, France, 06000
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89
Clinical Study Site
Paris, France, 75013
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90
Clinical Study Site
Paris, France, 75610
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91
Clinical Study Site
Strasbourg, France, 67200
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92
Cinical Study Site
Tours, France, 37000
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93
Clinical Study Site
Tours, France, 37000
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94
Clinical Study Site
Tbilisi, Georgia
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95
Cinical Study Site
München, Bavaria, Germany
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96
Clinical Study Site
Sande, Lower Saxony, Germany, 26452
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97
Clinical Study Site
Aachen, Germany, 52074
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98
Cinical Study Site
Greifswald, Germany, 17489
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99
Clinical Study Site
Rüdersdorf, Germany, 15562
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100
Clinical Study Site
Sande, Germany, 26452
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101
Cinical Study Site
Beersheba, Israel
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102
Cinical Study Site
Haifa, Israel, 3109601
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103
Cinical Study Site
Safed, Israel
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104
Clinical Study Site
Bergamo, Italy, 24127
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105
Clinical Study Site
Bologna, Italy, 40139
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106
Cinical Study Site
Genova, Italy, 16132
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107
Cinical Study Site
Gussago, Italy, 25064
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108
Cinical Study Site
Milan, Italy, 20126
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109
Cinical Study Site
Milan, Italy
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110
Cinical Study Site
Modena, Italy
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111
Clinical Study Site
Pavia, Italy, 27100
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112
Clinical Study Site
Ponderano, Italy, 13875
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113
Clinical Study Site
Roma, Italy, 00128
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114
Cinical Study Site
Roma, Italy, 00133
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115
Clinical Study Site #2
Roma, Italy, 00189
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116
Clinical Study Site
Roma, Italy
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117
Cinical Study Site
Terni, Italy
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118
Cinical Study Site
Riga, Latvia, LV-1002
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119
Clinical Study Site
Riga, Latvia, LV-1024
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120
Cinical Study Site
Kota Kinabalu, Sabah, Malaysia
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121
Cinical Study Site
Kuching, Sarawak, Malaysia
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122
Cinical Study Site
George Town, Malaysia, 11700
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123
Cinical Study Site
Johor Bahru, Malaysia, 80100
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124
Cinical Study Site
Kota Kinabalu, Malaysia
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125
Cinical Study Site
Kuala Lumpur, Malaysia, 50586
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126
Cinical Study Site
Kuala Lumpur, Malaysia, 50603
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127
Cinical Study Site
Kuala Lumpur, Malaysia, 56000
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128
Cinical Study Site
Kuching, Malaysia
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129
Cinical Study Site
Sungai Buloh, Malaysia
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130
Cinical Study Site
Amsterdam, Netherlands
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131
Cinical Study Site
Utrecht, Netherlands
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132
Clinical Study Site
Skopje, North Macedonia, 1000
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133
Cinical Study Site
Cebu City, Philippines
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134
Cinical Study Site
City of Muntinlupa, Philippines
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135
Cinical Study Site
Iloilo City, Philippines
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136
Clinical Study Site
Bydgoszcz, Poland, 85-090
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137
Clinical Study Site
Krakow, Poland, 30-688
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138
Clinical Study Site
Lublin, Poland, 20-701
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139
Clinical Study Site
Lublin, Poland, 20-718
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140
Clinical Study Site
Lublin, Poland, 7763138
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141
Cinical Study Site
Warsaw, Poland, 04-141
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142
Clinical Study Site
Wroclaw, Poland, 50-367
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143
Clinical Study Site
Bucharest, Romania, 050474
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144
Cinical Study Site
Târgu Mureş, Romania, 540136
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145
Cinical Study Site
Belgrade, Serbia, 11000
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146
Clinical Study Site
Belgrade, Serbia, 11000
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147
Clinical Study Site
Kragujevac, Serbia, 34000
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148
Clinical Study Site
Niš, Serbia, 18000
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149
Cinical Study Site
Daegu, South Korea
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150
Cinical Study Site
Daejeon, South Korea
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151
Cinical Study Site #2
Seoul, South Korea
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152
Cinical Study Site #3
Seoul, South Korea
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153
Cinical Study Site
Seoul, South Korea
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154
Cinical Study Site
Uijeongbu-si, South Korea
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155
Cinical Study Site
Yangsan, South Korea
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156
Clinical Study Site
Barcelona, Barcelona, Spain, 08916
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157
Clinical Study Site
Alicante, Spain, 03010
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158
Clinical Study Site
Barcelona, Spain, 08025
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159
Cinical Study Site
Barcelona, Spain, 08041
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160
Clinical Study Site
Bilbao, Spain, 48013
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161
Cinical Study Site #2
Bangkok, Thailand
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162
Cinical Study Site
Bangkok, Thailand
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163
Cinical Study Site
Hat Yai, Thailand
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164
Cinical Study Site
Khlong Luang, Thailand
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165
Cinical Study Site
Khon Kaen, Thailand, 40002
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166
Cinical Study Site
Khon Kaen, Thailand
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167
Clinical Study Site
Oxford, United Kingdom
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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
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