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A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of DNTH103 In Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)
Led by Dianthus Therapeutics · Updated on 2026-06-02
256
Participants Needed
168
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy of claseprubart (DNTH103) compared to a placebo in adults with chronic inflammatory demyelinating polyneuropathy (CIDP), a condition affecting the nerves. This Phase 3 study aims to assess how well claseprubart works in participants with typical or variant forms of CIDP, including motor or multifocal types. The study includes multiple periods to thoroughly investigate treatment effects and safety. Participants first enter an open-label period lasting up to 13 weeks, receiving an intravenous loading dose of claseprubart on Day 1 followed by subcutaneous injections every 2 weeks. Those who respond may then continue into a randomized, double-blind treatment phase for up to 52 weeks, receiving either claseprubart or placebo subcutaneously every 2 weeks. Eligible participants can join an optional open-label extension for up to 104 weeks and will be followed for safety for an additional 40 weeks. Throughout the study, participants will undergo assessments including the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) score, grip strength measurements, disability scales, quality of life evaluations, and monitoring for adverse events. Researchers will track the time to relapse and changes in disability and strength to evaluate treatment impact. Safety and drug levels will be monitored over the entire study period, which may last over 200 weeks for some participants.
CONDITIONS
Brief 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 kilograms and 120 kilograms
- Confirmed diagnosis of CIDP or possible CIDP, including typical, motor, or multifocal CIDP variants 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 of the following treatment conditions for CIDP: currently responding to immunoglobulin (IVIg or SCIg) alone or with oral corticosteroids; or previously responded but not currently treated with immunoglobulin; or currently responding to oral corticosteroids alone or with azathioprine or mycophenolate mofetil; or refractory with inadequate response/failure to immunoglobulin and/or corticosteroids; 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 effective contraception and not donate ova
- Male participants must agree not to donate sperm and use acceptable contraception or be surgically sterile for at least 90 days prior to screening
You will not qualify if you...
- Signs or symptoms suggesting polyneuropathy from causes other than CIDP
- Known central demyelination or history of myelopathy
- Significant medical or surgical conditions including acute illness or major surgery that may affect safety or study procedures
- Any other condition or prior therapy making participant unsuitable for the study
- Known complement deficiency or history of 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 outcome assessments, such as severe diabetic neuropathy, fibromyalgia, inflammatory arthritis, or osteoarthritis affecting hands and feet
- Prior history of Neisseria meningitidis infection
- History of active malignancy within 5 years prior to screening, except specified skin or low-grade cancers
- Positive tests for active HIV-1 or HIV-2, hepatitis B surface antigen, or hepatitis C antibodies
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.
screening and enrollment visit
Duration - Up to 13 weeks
Participants receive an intravenous loading dose on Day 1 followed by subcutaneous injections once every 2 weeks for up to 13 weeks.
Biweekly visits for up to 13 weeks
Duration - Up to 52 weeks
Participants who respond in the open-label period are randomized to receive subcutaneous injections of the study drug or placebo once every 2 weeks for up to 52 weeks.
Biweekly visits for up to 52 weeks
Duration - Up to 104 weeks
Eligible participants may continue to receive subcutaneous injections of the study drug once every 2 weeks for up to 104 weeks.
Biweekly visits for up to 104 weeks
Duration - 40 weeks
Participants are monitored for safety after completion of treatment periods.
Visits approximately during 40 weeks follow-up
Trial Site Locations
Total: 168 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 City, 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
Cinical Study Site
Manchester, England, United Kingdom
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168
Clinical Study Site
Oxford, United Kingdom
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Research Team
D
Dianthus Clinical Contact Center
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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