A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)
NCT ID: NCT06858579
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
480 participants
INTERVENTIONAL
2025-02-10
2030-12-31
Brief Summary
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Detailed Description
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* Part A: An open-label period (up to 13 weeks)
* Part B: A randomized, placebo-controlled, double-blind treatment period (up to 52 weeks) for participants who respond to DNTH103 in Part A
* Optional open-label extension (OLE) for eligible participants (up to 104 weeks)
* Safety follow-up (40 weeks)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DNTH103 (Part A)
DNTH103 intravenous (IV) loading dose on Day 1.
DNTH103 subcutaneous (SC) once every 2 weeks for up to 13 weeks.
DNTH103
IV Infusion
DNTH103
SC injection
DNTH103 Low Dose (Part B)
DNTH103 SC once every 2 weeks for up to 52 weeks.
DNTH103
SC injection
DNTH103 High Dose (Part B)
DNTH103 SC once every 2 weeks for up to 52 weeks.
DNTH103
SC injection
Placebo (Part B)
Placebo SC once every 2 weeks for up to 52 weeks.
Placebo
SC injection
DNTH103 (Optional OLE)
DNTH103 SC once every 2 weeks for up to 104 weeks.
DNTH103
SC injection
Interventions
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DNTH103
IV Infusion
DNTH103
SC injection
Placebo
SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Weight range between 40 kilograms (kg) and 120 kg.
3. Confirmed diagnosis of CIDP or possible CIDP. Participants must have either typical CIDP or one of the following variants: motor or multifocal CIDP. Diagnosis must be confirmed by the Independent CIDP Review Panel.
4. CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.
5. Must be neurologically stable.
6. Must have an INCAT score between 2 and 9 inclusive.
7. Must fulfill one of the following treatment conditions for CIDP:
1. Currently treated with and responded to immunoglobulin (Ig) (intravenous immunoglobulin \[IVIg\] or subcutaneous immunoglobulin \[SCIg\]) alone or Ig (IVIg or SCIg) plus oral corticosteroids, or previously treated with and responded to, but are no longer being treated with (eg, lost access to), a maintenance regimen of Ig (IVIg or SCIg) alone or Ig (IVIg or SCIg) plus oral corticosteroids.
2. Currently treated with and responded to oral corticosteroids alone or oral corticosteroids in combination with azathioprine or mycophenolate mofetil.
3. Refractory participants who have had treatment failure (worsening) or an inadequate response to Ig and/or oral corticosteroids (defined as no clinically meaningful improvement after a period of a minimum of 12 weeks, which may include both active treatment and observation to assess response), or who at any time were unable to tolerate these treatments, experienced adverse effects, or have documented contraindications.
4. Treatment naïve with no history of prior treatment for CIDP.
8. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.
9. Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.
10. Male participants must be surgically sterile for at least 90 days prior to Screening or agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception.
Exclusion Criteria
2. Known evidence of central demyelination or known history of myelopathy.
3. History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant or that could have a potential impact on safety/efficacy or study procedures.
4. Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study.
5. Known complement deficiency or history of positive titer for anti-C1 antibodies.
6. Diagnosis of systemic lupus erythematosus (SLE) or family history of SLE (defined as a parent, sibling, or child).
7. Participants with an autoimmune disease affecting joints, muscle or nervous system.
8. Any coexisting or overlapping condition, which may interfere with outcome assessments, such as severe diabetic neuropathy, fibromyalgia, inflammatory arthritis or osteoarthritis affecting the hands and feet.
9. Prior history of N. meningitidis infection.
10. History of active malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone.
11. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.
18 Years
75 Years
ALL
No
Sponsors
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Dianthus Therapeutics
INDUSTRY
Responsible Party
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Locations
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Clinical Study Site
Birmingham, Alabama, United States
Clinical Study Site
Phoenix, Arizona, United States
Clinical Study Site
Scottsdale, Arizona, United States
Clinical Study Site
Los Angeles, California, United States
Clinical Study Site
San Francisco, California, United States
Clinical Study Site
San Francisco, California, United States
Clinical Study Site
Washington D.C., District of Columbia, United States
Clinical Study Site
Maitland, Florida, United States
Clinical Study Site
Tampa, Florida, United States
Clinical Study Site
Honolulu, Hawaii, United States
Clinical Study Site
Chicago, Illinois, United States
Clinical Study Site
Edwardsville, Illinois, United States
Clinical Study Site
Indianapolis, Indiana, United States
Clinical Study Site
Kansas City, Kansas, United States
Clinical Study Site
Burlington, Massachusetts, United States
Clinical Study Site
East Lansing, Michigan, United States
Clinical Study Site
Omaha, Nebraska, United States
Clinical Study Site
New York, New York, United States
Clinical Study Site
New York, New York, United States
Clinical Study Site
Cincinnati, Ohio, United States
Clinical Study Site
Columbus, Ohio, United States
Clinical Study Site
Portland, Oregon, United States
Clinical Study Site
Dallas, Texas, United States
Clinical Study Site
Denton, Texas, United States
Cinical Study Site
Houston, Texas, United States
Texas Locations
Houston, Texas, United States
Clinical Study Site
Round Rock, Texas, United States
Clinical Study Site
Sugar Land, Texas, United States
Clinical Study Site
Seattle, Washington, United States
Cinical Study Site
Buenos Aires, Buenos Aires, Argentina
Cinical Study Site #3
Buenos Aires, , Argentina
Cinical Study Site #4
Buenos Aires, , Argentina
Clinical Study Site #2
Buenos Aires, , Argentina
Clinical Study Site
Buenos Aires, , Argentina
Cinical Study Site #2
San Miguel de Tucumán, , Argentina
Clinical Study Site
San Miguel de Tucumán, , Argentina
Clinical Study Site
Randwick, New South Wales, Australia
Clinical Study Site
Melbourne, Victoria, Australia
Cinical Study Site
Rio de Janeiro, Rio de Janeiro, Brazil
Cinical Study Site
Natal, , Brazil
Cinical Study Site
Salvador, , Brazil
Cinical Study Site
São Paulo, , Brazil
Cinical Study Site
São Paulo, , Brazil
Cinical Study Site
Sofia, , Bulgaria
Clinical Study Site
Sofia, , Bulgaria
Clinical Study Site
Hefei, Anhui, China
Clinical Study Site
Guangzhou, Guangdong, China
Clinical Study Site
Changsha, Hu'Nan, China
Clinical Study Site
Changsha, Hu'Nan, China
Clinical Study Site
Wuhan, Hubei, China
Clinical Study Site
Chifeng, Inner Mongolia, China
Clinical Study Site
Suzhou, Jiangsu, China
Clinical Study Site
Beijing, , China
Clinical Study Site
Beijing, , China
Clinical Study Site
Chengdu, , China
Clinical Study Site
Fujian, , China
Clinical Study Site
Guangdong, , China
Clinical Study Site
Guangzhou, , China
Clinical Study Site
Jilin, , China
Clinical Study Site
Shanghai, , China
Clinical Study Site
Shanghai, , China
Clinical Study Site
Sichuan, , China
Clinical Study Site
Taiyuan, , China
Clinical Study Site
Wuhan, , China
Clinical Study Site
Aarhus, , Denmark
Clinical Study Site
Copenhagen, , Denmark
Clinical Study Site
Bordeaux, , France
Cinical Study Site
Brest, , France
Clinical Study Site
Bron, , France
Clinical Study Site
Clermont-Ferrand, , France
Clinical Study Site
Libourne, , France
Clinical Study Site
Marseille, , France
Clinical Study Site
Nice, , France
Clinical Study Site
Paris, , France
Clinical Study Site
Paris, , France
Clinical Study Site
Strasbourg, , France
Cinical Study Site
Tours, , France
Clinical Study Site
Tours, , France
Clinical Study Site
Tbilisi, , Georgia
Clinical Study Site
Sande, Lower Saxony, Germany
Clinical Study Site
Aachen, , Germany
Cinical Study Site
Greifswald, , Germany
Clinical Study Site
Rüdersdorf, , Germany
Clinical Study Site
Sande, , Germany
Clinical Study Site
Bergamo, , Italy
Clinical Study Site
Bologna, , Italy
Cinical Study Site
Genova, , Italy
Cinical Study Site
Gussago, , Italy
Cinical Study Site
Milan, , Italy
Clinical Study Site
Pavia, , Italy
Clinical Study Site
Ponderano, , Italy
Clinical Study Site
Roma, , Italy
Clinical Study Site #2
Roma, , Italy
Clinical Study Site
Roma, , Italy
Cinical Study Site
Riga, , Latvia
Clinical Study Site
Riga, , Latvia
Cinical Study Site
George Town, , Malaysia
Cinical Study Site
Johor Bahru, , Malaysia
Cinical Study Site
Kuala Lumpur, , Malaysia
Cinical Study Site
Kuala Lumpur, , Malaysia
Cinical Study Site
Kuala Lumpur, , Malaysia
Cinical Study Site
Utrecht, , Netherlands
Clinical Study Site
Bydgoszcz, , Poland
Clinical Study Site
Krakow, , Poland
Clinical Study Site
Lublin, , Poland
Clinical Study Site
Lublin, , Poland
Clinical Study Site
Lublin, , Poland
Cinical Study Site
Warsaw, , Poland
Clinical Study Site
Wroclaw, , Poland
Clinical Study Site
Bucharest, , Romania
Cinical Study Site
Belgrade, , Serbia
Clinical Study Site
Belgrade, , Serbia
Clinical Study Site
Kragujevac, , Serbia
Clinical Study Site
Niš, , Serbia
Cinical Study Site
Daegu, , South Korea
Cinical Study Site
Daejeon, , South Korea
Cinical Study Site #2
Seoul, , South Korea
Cinical Study Site #3
Seoul, , South Korea
Cinical Study Site
Seoul, , South Korea
Cinical Study Site
Yangsan, , South Korea
Clinical Study Site
Barcelona, Barcelona, Spain
Clinical Study Site
Alicante, , Spain
Clinical Study Site
Barcelona, , Spain
Cinical Study Site
Barcelona, , Spain
Clinical Study Site
Bilbao, , Spain
Clinical Study Site
Oxford, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-517529-26
Identifier Type: OTHER
Identifier Source: secondary_id
DNTH103-CIDP-301
Identifier Type: -
Identifier Source: org_study_id
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