Chronic Inflammatory Demyelinating PolyneuropathyPhase 3CAPTIVATENCT06858579
A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)
A Phase 3 study testing Claseprubart in people with Chronic Inflammatory Demyelinating Polyneuropathy, run by Dianthus Therapeutics at 201 sites in 31 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy
- What is being tested?
- Claseprubart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 201 sitesin 31 countries
- Study dates
- 10 Feb 2025to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have given written informed consent before any study-related activities are carried out.
- Weight range between 40 kilograms (kg) and 120 kg.
- 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.
- CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.
- Must be neurologically stable.
- Must have an INCAT score between 2 and 9 inclusive.
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- Must fulfill one of the following treatment conditions for CIDP:
- 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.
- Currently treated with and responded to oral corticosteroids alone or oral corticosteroids in combination with azathioprine or mycophenolate mofetil.
- 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.
- Treatment naïve with no history of prior treatment for CIDP.
- Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.
- 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.
- Male participants must 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 or be surgically sterile for at least 90 days prior to Screening.
Who cannot join
- Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.
- Known evidence of central demyelination or known history of myelopathy.
- 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.
- Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study.
- Known complement deficiency or history of positive titer for anti-C1 antibodies.
- Diagnosis of systemic lupus erythematosus (SLE) or family history of SLE (defined as a parent, sibling, or child).
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- Participants with an autoimmune disease affecting joints, muscle or nervous system.
- 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.
- Prior history of N. meningitidis infection.
- 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.
- Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.
Trial locations and contacts
201 sites in 31 countries. Contact the study team or a site near you to ask about taking part.
201 sites in 31 countries
United States32 sites, 32 recruiting
- Recruiting
Clinical Study Site
Birmingham, Alabama, 35294
- Recruiting
Clinical Study Site
Burlington, Massachusetts, 01805
- Recruiting
Clinical Study Site
Chicago, Illinois, 60611
- Recruiting
Clinical Study Site
Cincinnati, Ohio, 45219
- Recruiting
Clinical Study Site
Columbus, Ohio, 43221
- Recruiting
Clinical Study Site
Dallas, Texas, 75243
- Recruiting
Clinical Study Site
Denton, Texas, 76208
- Recruiting
Clinical Study Site
East Lansing, Michigan, 48824
- Recruiting
Clinical Study Site
Edwardsville, Illinois, 62025
- Recruiting
Clinical Study Site
Honolulu, Hawaii, 96817
- Recruiting
Cinical Study Site
Houston, Texas, 77030
- Recruiting
Texas Locations
Houston, Texas, 77054
- Recruiting
Clinical Study Site
Indianapolis, Indiana, 46202
- Recruiting
Clinical Study Site
Kansas City, Kansas, 66160
- Recruiting
Cinical Study Site
Lebanon, New Hampshire, 03766
- Recruiting
Clinical Study Site
Los Angeles, California, 90048
- Recruiting
Clinical Study Site
Maitland, Florida, 32751
- Recruiting
Cinical Study Site
Nashville, Tennessee, 37232
- Recruiting
Cinical Study Site
New Haven, Connecticut, 06520
- Recruiting
Clinical Study Site
New York, New York, 10021
- Recruiting
Clinical Study Site
New York, New York, 10032
- Recruiting
Clinical Study Site
Omaha, Nebraska, 68198
- Recruiting
Clinical Study Site
Phoenix, Arizona, 85028
- Recruiting
Clinical Study Site
Portland, Oregon, 97239
- Recruiting
Clinical Study Site
Round Rock, Texas, 78681
- Recruiting
Clinical Study Site
San Francisco, California, 94109
- Recruiting
Clinical Study Site
San Francisco, California, 94158
- Recruiting
Clinical Study Site
Scottsdale, Arizona, 85251'
- Recruiting
Clinical Study Site
Seattle, Washington, 98195
- Recruiting
Clinical Study Site
Sugar Land, Texas, 77478
- Recruiting
Clinical Study Site
Tampa, Florida, 33620
- Recruiting
Clinical Study Site
Washington D.C., District of Columbia, 20007
China18 sites, 18 recruiting
- Recruiting
Clinical Study Site
Beijing, 100034
- Recruiting
Clinical Study Site
Beijing, 100191
- Recruiting
Clinical Study Site
Changsha, Hu'Nan, 410008
- Recruiting
Clinical Study Site
Changsha, Hu'Nan, 410013
- Recruiting
Clinical Study Site
Chengdu, 610072
- Recruiting
Clinical Study Site
Chifeng, Inner Mongolia, 024050
- Recruiting
Clinical Study Site
Fujian, 350001
- Recruiting
Clinical Study Site
Guangdong, 510180
- Recruiting
Clinical Study Site
Guangzhou, Guangdong, 510080
- Recruiting
Clinical Study Site
Guangzhou, 510515
- Recruiting
Clinical Study Site
Hefei, Anhui, 230001
- Recruiting
Clinical Study Site
Jilin City, 130021
- Recruiting
Clinical Study Site
Shanghai, 200031
- Recruiting
Clinical Study Site
Shanghai, 200040
- Recruiting
Clinical Study Site
Sichuan, 610072
- Recruiting
Clinical Study Site
Suzhou, Jiangsu, 215006
- Recruiting
Clinical Study Site
Taiyuan
- Recruiting
Clinical Study Site
Wuhan
Italy17 sites, 17 recruiting
- Recruiting
Clinical Study Site
Bergamo, 24127
- Recruiting
Clinical Study Site
Bologna, 40139
- Recruiting
Cinical Study Site
Genova, 16132
- Recruiting
Cinical Study Site
Gussago, 25064
- Recruiting
Cinical Study Site
Milan, 20126
- Recruiting
Cinical Study Site
Milan, 20132
- Recruiting
Cinical Study Site
Milan
- Recruiting
Cinical Study Site
Modena
- Recruiting
Clinical Study Site
Monza, 20900
- Recruiting
Clinical Study Site
Pavia, 27100
- Recruiting
Clinical Study Site
Ponderano, 13875
- Recruiting
Clinical Study Site
Roma, 00128
- Recruiting
Cinical Study Site
Roma, 00133
- Recruiting
Clinical Study Site #2
Roma, 00189
- Recruiting
Clinical Study Site
Roma
- Recruiting
Cinical Study Site
Salerno, 84131
- Recruiting
Cinical Study Site
Terni
Japan13 sites, 13 recruiting
- Recruiting
Cinical Study Site
Chiba, 260-8677
- Recruiting
Cinical Study Site
Hirakata, Osaka
- Recruiting
Cinical Study Site
Kawagoe, Saitama
- Recruiting
Cinical Study Site
Kawasaki, Kanto
- Recruiting
Cinical Study Site
Kurashiki, Okayama-ken, 701-0192
- Recruiting
Cinical Study Site #2
Kyoto, 606-8507
- Recruiting
Cinical Study Site
Nagoya, 466-8560
- Recruiting
Cinical Study Site
Niigata, Chubu
- Recruiting
Cinical Study Site
Sapporo, 060-8556
- Recruiting
Cinical Study Site
Tokyo, 152-8550
- Recruiting
Cinical Study Site
Tokyo
- Recruiting
Cinical Study Site
Tsukuba, Kanto
- Recruiting
Cinical Study Site
Ube, Yamaguchi, 755-0046
France12 sites, 12 recruiting
- Recruiting
Clinical Study Site
Bordeaux, 33000
- Recruiting
Cinical Study Site
Brest, 29200
- Recruiting
Clinical Study Site
Bron, 69500
- Recruiting
Clinical Study Site
Clermont-Ferrand, 63000
- Recruiting
Clinical Study Site
Libourne, 33500
- Recruiting
Clinical Study Site
Marseille, 13005
- Recruiting
Clinical Study Site
Nice, 06000
- Recruiting
Clinical Study Site
Paris, 75013
- Recruiting
Clinical Study Site
Paris, 75610
- Recruiting
Clinical Study Site
Strasbourg, 67200
- Recruiting
Cinical Study Site
Tours, 37000
- Recruiting
Clinical Study Site
Tours, 37000
Malaysia12 sites, 12 recruiting
- Recruiting
Cinical Study Site
George Town, 11700
- Recruiting
Cinical Study Site
Johor Bahru, 80100
- Recruiting
Cinical Study Site
Kota Kinabalu, Sabah
- Recruiting
Cinical Study Site
Kota Kinabalu
- Recruiting
Cinical Study Site
Kuala Lumpur, 50586
- Recruiting
Cinical Study Site
Kuala Lumpur, 50603
- Recruiting
Cinical Study Site
Kuala Lumpur, 56000
- Recruiting
Cinical Study Site
Kuching, Sarawak
- Recruiting
Cinical Study Site
Kuching
- Recruiting
Cinical Study Site
Serdang, Salangor
- Recruiting
Cinical Study Site
Serdang, 43400
- Recruiting
Cinical Study Site
Sungai Buloh
Argentina9 sites, 9 recruiting
- Recruiting
Cinical Study Site
Buenos Aires, Buenos Aires
- Recruiting
Cinical Study Site #3
Buenos Aires
- Recruiting
Cinical Study Site #4
Buenos Aires
- Recruiting
Cinical Study Site
Buenos Aires
- Recruiting
Clinical Study Site #2
Buenos Aires
- Recruiting
Clinical Study Site
Buenos Aires
- Recruiting
Cinical Study Site
Rosario, Santa Fe Province
- Recruiting
Cinical Study Site #2
San Miguel de Tucumán
- Recruiting
Clinical Study Site
San Miguel de Tucumán
Brazil9 sites, 9 recruiting
- Recruiting
Cinical Study Site
Belo Horizonte, 30130-100
- Recruiting
Clinical Study Site
Campinas, São Paulo
- Recruiting
Cinical Study Site
Natal
- Recruiting
Cinical Study Site
Porto Alegre, 90610-000
- Recruiting
Cinical Study Site
Rio de Janeiro, Rio de Janeiro, 20551-030
- Recruiting
Cinical Study Site
Salvador, 40290-000
- Recruiting
Cinical Study Site
São Paulo, 04038
- Recruiting
Cinical Study Site
São Paulo, 05403-000
- Recruiting
Cinical Study Site
São Paulo
Poland8 sites, 8 recruiting
- Recruiting
Clinical Study Site
Bydgoszcz, 85-090
- Recruiting
Clinical Study Site
Krakow, 30-688
- Recruiting
Cinical Study Site
Lodz, 90-324
- Recruiting
Clinical Study Site
Lublin, 20-701
- Recruiting
Clinical Study Site
Lublin, 20-718
- Recruiting
Clinical Study Site
Lublin, 7763138
- Recruiting
Cinical Study Site
Warsaw, 04-141
- Recruiting
Clinical Study Site
Wroclaw, 50-367
Thailand8 sites, 8 recruiting
- Recruiting
Cinical Study Site
Bangkok, 10400
- Recruiting
Cinical Study Site #2
Bangkok
- Recruiting
Cinical Study Site
Bangkok
- Recruiting
Cinical Study Site
Chiang Mai, 50200
- Recruiting
Cinical Study Site
Hat Yai
- Recruiting
Cinical Study Site
Khlong Luang
- Recruiting
Cinical Study Site
Khon Kaen, 40002
- Recruiting
Cinical Study Site
Khon Kaen
South Korea7 sites, 7 recruiting
- Recruiting
Cinical Study Site
Daegu
- Recruiting
Cinical Study Site
Daejeon
- Recruiting
Cinical Study Site #2
Seoul
- Recruiting
Cinical Study Site #3
Seoul
- Recruiting
Cinical Study Site
Seoul
- Recruiting
Cinical Study Site
Uijeongbu-si
- Recruiting
Cinical Study Site
Yangsan
Australia6 sites, 6 recruiting
- Recruiting
Cinical Study Site
Liverpool, New South Wales
- Recruiting
Clinical Study Site
Melbourne, Victoria, 3004
- Recruiting
Clinical Study Site
Randwick, New South Wales, 2031
- Recruiting
Cinical Study Site
Saint Leonards, New South Wales, 2065
- Recruiting
Cinical Study Site
Southport, Queensland, 4215
- Recruiting
Cinical Study Site
Sydney, New South Wales, 2033
Germany6 sites, 6 recruiting
- Recruiting
Clinical Study Site
Aachen, 52074
- Recruiting
Cinical Study Site
Greifswald, 17489
- Recruiting
Cinical Study Site
München, Bavaria
- Recruiting
Clinical Study Site
Rüdersdorf, 15562
- Recruiting
Clinical Study Site
Sande, Lower Saxony, 26452
- Recruiting
Clinical Study Site
Sande, 26452
Spain5 sites, 5 recruiting
- Recruiting
Clinical Study Site
Alicante, 03010
- Recruiting
Clinical Study Site
Barcelona, Barcelona, 08916
- Recruiting
Clinical Study Site
Barcelona, 08025
- Recruiting
Cinical Study Site
Barcelona, 08041
- Recruiting
Clinical Study Site
Bilbao, 48013
Turkey (Türkiye)5 sites, 5 recruiting
- Recruiting
Cinical Study Site
Ankara, 06230
- Recruiting
Cinical Study Site
Bursa
- Recruiting
Cinical Study Site
Istanbul
- Recruiting
Cinical Study Site
Samsun
- Recruiting
Cinical Study Site
Zeytinburnu, 34010
Philippines4 sites, 4 recruiting
- Recruiting
Cinical Study Site
Batangas
- Recruiting
Cinical Study Site
Cebu City
- Recruiting
Cinical Study Site
City of Muntinlupa
- Recruiting
Cinical Study Site
Iloilo City
Serbia4 sites, 4 recruiting
- Recruiting
Cinical Study Site
Belgrade, 11000
- Recruiting
Clinical Study Site
Belgrade, 11000
- Recruiting
Clinical Study Site
Kragujevac, 34000
- Recruiting
Clinical Study Site
Niš, 18000
Colombia3 sites, 3 recruiting
- Recruiting
Cinical Study Site
Antioquia
- Recruiting
Cinical Study Site
Medellín, Antioquia
- Recruiting
Cinical Study Site
Medellín
Israel3 sites, 3 recruiting
- Recruiting
Cinical Study Site
Beersheba
- Recruiting
Cinical Study Site
Haifa, 3109601
- Recruiting
Cinical Study Site
Safed
Belgium2 sites, 2 recruiting
- Recruiting
Cinical Study Site
Anderlecht, Brussels Capital
- Recruiting
Cinical Study Site
Brussels
Bulgaria2 sites, 2 recruiting
- Recruiting
Cinical Study Site
Sofia
- Recruiting
Clinical Study Site
Sofia
Denmark2 sites, 2 recruiting
- Recruiting
Clinical Study Site
Aarhus, 8200
- Recruiting
Clinical Study Site
Copenhagen
Latvia2 sites, 2 recruiting
- Recruiting
Cinical Study Site
Riga, LV-1002
- Recruiting
Clinical Study Site
Riga, LV-1024
Netherlands2 sites, 2 recruiting
- Recruiting
Cinical Study Site
Amsterdam
- Recruiting
Cinical Study Site
Utrecht
Romania2 sites, 2 recruiting
- Recruiting
Clinical Study Site
Bucharest, 050474
- Recruiting
Cinical Study Site
Târgu Mureş, 540136
United Kingdom2 sites, 2 recruiting
- Recruiting
Cinical Study Site
Manchester, England
- Recruiting
Clinical Study Site
Oxford
Vietnam2 sites, 2 recruiting
- Recruiting
Cinical Study Site #2
Hanoi
- Recruiting
Cinical Study Site
Hanoi
North Macedonia1 site, 1 recruiting
- Recruiting
Clinical Study Site
Skopje, 1000
About this study
Official title: 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)
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).
Read the detailed description
The study includes the following periods:
- 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)
- Being tested
- Claseprubart, Placebo
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClaseprubartDrug
Also called DNTH103
IV Infusion
ClaseprubartDrug
Also called DNTH103
SC injection
PlaceboDrug
SC injection
| Study group | Role | What they receive |
|---|---|---|
| Claseprubart (Part A) | Experimental | Claseprubart intravenous (IV) loading dose on Day 1.
Claseprubart subcutaneous (SC) once every 2 weeks for up to 13 weeks. Receives: Drug: Claseprubart |
| Claseprubart (Part B) | Experimental | Claseprubart SC once every 2 weeks for up to 52 weeks. Receives: Drug: Claseprubart |
| Placebo (Part B) | Placebo comparator | Placebo SC once every 2 weeks for up to 52 weeks. Receives: Drug: Placebo |
| Claseprubart (Optional OLE) | Experimental | Claseprubart SC once every 2 weeks for up to 104 weeks. Receives: Drug: Claseprubart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part B: Time From First Dose to Relapse as Assessed by the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT)
Adjusted INCAT scores range from 0-10 with a score of 10 indicating the greatest degree of disability. A relapse is defined as an increase of ≥1 point from baseline in adjusted INCAT score.
Measured: Part B baseline to Part B end of treatment period (up to Week 52)
Secondary outcomes (17)
Part B: Time to Decrease of ≥ 4 Points (Centile Metric) in Inflammatory Rasch-built Overall Disability Scale (I-RODS) Score
The I-RODS score ranges from 0-100, with lower scores indicating the greatest degree of disability.
Measured: Part B baseline to Part B end of treatment period (up to Week 52)
Part B: Time to Decrease of ≥ 8 kilopascal (kPa) in Grip Strength in the Dominant Hand
This is measured with a handheld device called a vigorimeter.
Measured: Part B baseline to Part B end of treatment period (up to Week 52)
Part B: Percentage of Participants who Relapse as Assessed by the Adjusted INCAT
Adjusted INCAT scores range from 0-10 with a score of 10 indicating the greatest degree of disability. A relapse is defined as an increase of ≥1 point from baseline in adjusted INCAT score.
Measured: Part B baseline to end of treatment period for Part B (up to Week 52)
Parts A and B: Change in I-RODS Score (Centile Metric)
The I-RODS score ranges from 0-100, with lower scores indicating the greatest degree of disability.
Measured: Part A baseline up to Part A end of treatment period (up to Week 13); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Parts A and B: Change in Grip Strength in the Dominant Hand
This is measured with a handheld device called a vigorimeter.
Measured: Part A baseline to Part A end of treatment period (up to Week 13); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Parts A and B: Change in Adjusted INCAT Score
Adjusted INCAT scores range from 0-10 with a score of 10 indicating the greatest degree of disability.
Measured: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Parts A and B: Change in Grip Strength in the Nondominant Hand
This is measured with a handheld device called a vigorimeter.
Measured: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Parts A and B: Change in Medical Research Council Sum Score (MRC-SS)
The MRC-SS ranges from 0 to 60 with a lower score indicating greater muscle weakness.
Measured: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Part A: Percentage of Participants with a Confirmed Response to DNTH103 as Assessed by the Adjusted INCAT
Adjusted INCAT scores range from 0-10 with a score of 10 indicating the greatest degree of disability. A response is defined as a decrease of ≥1 point from baseline in adjusted INCAT score.
Measured: Part A baseline to Part A end of treatment period (up to Week 13)
Parts A and B: Change in Euro-Quality of Life Visual Analogue Scale (EQ-VAS)
Participants mark their health status from 0 to 100 with 100 indicating the best health state.
Measured: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Parts A and B: Change in Fatigue Severity Scale (FSS)
FSS assesses disabling fatigue in participants with chronic illness.
Measured: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Parts A and B and OLE: Change in Adjusted INCAT Score
Adjusted INCAT scores range from 0-10 with a score of 10 indicating the greatest degree of disability.
Measured: Part A baseline to OLE Week 52 and Week 104; Part B baseline to OLE Week 52 and Week 104; OLE baseline to OLE Week 52 and Week 104
Part B and OLE: Percentage of Participants With a Confirmed Relapse as Assessed by the Adjusted INCAT
Adjusted INCAT scores range from 0-10 with a score of 10 indicating the greatest degree of disability. A relapse is defined as an increase of ≥1 point from baseline in adjusted INCAT score.
Measured: Part B baseline to OLE Week 52 and Week 104; OLE baseline to OLE Week 52 and Week 104
Parts A, B, OLE, and Safety Follow-up: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs)
An adverse event (AE) is any undesirable experience associated with the use of a medicine, which does not necessarily have a causal relationship with the medicine. A TEAE is an AE with onset after the start of the medicine, or any worsening of a pre-existing medical condition/AE after the start of the medicine. An SAE is an AE that can cause disability, is life-threatening, results in hospitalization or death, or is a birth defect.
Measured: Part A baseline through Safety Follow-up period (up to approximately 209 weeks)
Parts A, B, OLE, and Safety Follow-up: Serum Concentrations of DNTH103
Blood samples will be collected for measurement of serum concentrations of DNTH103 at various timepoints both pre- and post-dose.
Measured: Part A baseline through Safety Follow-up period (up to approximately 209 weeks)
Parts A, B, and OLE: Change from Baseline in Complement Total Blood Test (CH50)
Blood samples will be collected to determine changes in CH50 at various timepoints.
Measured: Part A baseline through Safety Follow-up period (up to approximately 209 weeks)
Parts A, B, OLE, and Safety Follow-up: Incidence and Titer of Antidrug Antibodies (ADAs)
Blood samples will be collected to measure ADA against DNTH103 at various timepoints.
Measured: Part A baseline through Safety Follow-up period (up to approximately 209 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start10 Feb 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dianthus Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858579
- Sponsor's protocol ID
- DNTH103-CIDP-301
- Other IDs
- 2024-517529-26
- Acronym
- CAPTIVATE
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06858579
- Acronym / sponsor ID
- CAPTIVATE / DNTH103-CIDP-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Dianthus TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study includes the following periods:
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Claseprubart (Part A) | Experimental | Drug: ClaseprubartClaseprubart intravenous (IV) loading dose on Day 1. Claseprubart subcutaneous (SC) once every 2 weeks for up to 13 weeks. |
| Claseprubart (Part B) | Experimental | Drug: ClaseprubartClaseprubart SC once every 2 weeks for up to 52 weeks. |
| Placebo (Part B) | Placebo comparator | Drug: PlaceboPlacebo SC once every 2 weeks for up to 52 weeks. |
| Claseprubart (Optional OLE) | Experimental | Drug: ClaseprubartClaseprubart SC once every 2 weeks for up to 104 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Must have given written informed consent before any study-related activities are carried out.
- Weight range between 40 kilograms (kg) and 120 kg.
- 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.
- CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.
- Must be neurologically stable.
Key exclusion criteria (11 listed)
- Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.
- Known evidence of central demyelination or known history of myelopathy.
- 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.
- Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study.
- Known complement deficiency or history of positive titer for anti-C1 antibodies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClaseprubartAlso: DNTH103IV Infusion | Drug | Claseprubart (Part A) |
| ClaseprubartAlso: DNTH103SC injection | Drug | Claseprubart (Optional OLE), Claseprubart (Part A), Claseprubart (Part B) |
| PlaceboSC injection | Drug | Placebo (Part B) |
Primary outcome
Part B: Time From First Dose to Relapse as Assessed by the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT)
Time frame: Part B baseline to Part B end of treatment period (up to Week 52)
Adjusted INCAT scores range from 0-10 with a score of 10 indicating the greatest degree of disability. A relapse is defined as an increase of ≥1 point from baseline in adjusted INCAT score.
17 secondary outcomes
Part B: Time to Decrease of ≥ 4 Points (Centile Metric) in Inflammatory Rasch-built Overall Disability Scale (I-RODS) Score
Time frame: Part B baseline to Part B end of treatment period (up to Week 52)
Part B: Time to Decrease of ≥ 8 kilopascal (kPa) in Grip Strength in the Dominant Hand
Time frame: Part B baseline to Part B end of treatment period (up to Week 52)
Part B: Percentage of Participants who Relapse as Assessed by the Adjusted INCAT
Time frame: Part B baseline to end of treatment period for Part B (up to Week 52)
Parts A and B: Change in I-RODS Score (Centile Metric)
Time frame: Part A baseline up to Part A end of treatment period (up to Week 13); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Parts A and B: Change in Grip Strength in the Dominant Hand
Time frame: Part A baseline to Part A end of treatment period (up to Week 13); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Parts A and B: Change in Adjusted INCAT Score
Time frame: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Parts A and B: Change in Grip Strength in the Nondominant Hand
Time frame: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Parts A and B: Change in Medical Research Council Sum Score (MRC-SS)
Time frame: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Part A: Percentage of Participants with a Confirmed Response to DNTH103 as Assessed by the Adjusted INCAT
Time frame: Part A baseline to Part A end of treatment period (up to Week 13)
Parts A and B: Change in Euro-Quality of Life Visual Analogue Scale (EQ-VAS)
Time frame: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Parts A and B: Change in Fatigue Severity Scale (FSS)
Time frame: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Parts A and B and OLE: Change in Adjusted INCAT Score
Time frame: Part A baseline to OLE Week 52 and Week 104; Part B baseline to OLE Week 52 and Week 104; OLE baseline to OLE Week 52 and Week 104
Part B and OLE: Percentage of Participants With a Confirmed Relapse as Assessed by the Adjusted INCAT
Time frame: Part B baseline to OLE Week 52 and Week 104; OLE baseline to OLE Week 52 and Week 104
Parts A, B, OLE, and Safety Follow-up: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs)
Time frame: Part A baseline through Safety Follow-up period (up to approximately 209 weeks)
Parts A, B, OLE, and Safety Follow-up: Serum Concentrations of DNTH103
Time frame: Part A baseline through Safety Follow-up period (up to approximately 209 weeks)
Parts A, B, and OLE: Change from Baseline in Complement Total Blood Test (CH50)
Time frame: Part A baseline through Safety Follow-up period (up to approximately 209 weeks)
Parts A, B, OLE, and Safety Follow-up: Incidence and Titer of Antidrug Antibodies (ADAs)
Time frame: Part A baseline through Safety Follow-up period (up to approximately 209 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
201 sites in 31 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Claseprubart in people with Chronic Inflammatory Demyelinating Polyneuropathy, run by Dianthus Therapeutics at 201 sites in 31 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 201 sites in United States, China, Italy, Japan, France and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dianthus Clinical Contact Center (929-999-4055, clinicaltrials@dianthustx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part B: Time From First Dose to Relapse as Assessed by the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) (time frame: Part B baseline to Part B end of treatment period (up to Week 52)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.