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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517529-26 | Other Identifier | EU CT Number |
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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).
The study includes the following periods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Claseprubart (Part A) | Experimental | Claseprubart intravenous (IV) loading dose on Day 1. Claseprubart subcutaneous (SC) once every 2 weeks for up to 13 weeks. |
|
| Claseprubart (Part B) | Experimental | Claseprubart SC once every 2 weeks for up to 52 weeks. |
|
| Placebo (Part B) | Placebo Comparator | Placebo SC once every 2 weeks for up to 52 weeks. |
|
| Claseprubart (Optional OLE) | Experimental | Claseprubart SC once every 2 weeks for up to 104 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Claseprubart | Drug | IV Infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Part B baseline to Part B end of treatment period (up to Week 52) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
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.
Must fulfill one of the following treatment conditions 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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dianthus Clinical Contact Center | Contact | 929-999-4055 | clinicaltrials@dianthustx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Study Site | Recruiting | Birmingham | Alabama | 35294 | United States | |
| Clinical Study Site |
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| Claseprubart | Drug | SC injection |
|
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| Placebo | Drug | SC injection |
|
This is measured with a handheld device called a vigorimeter. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Part A baseline through Safety Follow-up period (up to approximately 209 weeks) |
| Recruiting |
| Phoenix |
| Arizona |
| 85028 |
| United States |
| Clinical Study Site | Recruiting | Scottsdale | Arizona | 85251' | United States |
| Clinical Study Site | Recruiting | Los Angeles | California | 90048 | United States |
| Clinical Study Site | Recruiting | San Francisco | California | 94109 | United States |
| Clinical Study Site | Recruiting | San Francisco | California | 94158 | United States |
| Clinical Study Site | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
| Clinical Study Site | Recruiting | Maitland | Florida | 32751 | United States |
| Clinical Study Site | Recruiting | Tampa | Florida | 33620 | United States |
| Clinical Study Site | Recruiting | Honolulu | Hawaii | 96817 | United States |
| Clinical Study Site | Recruiting | Chicago | Illinois | 60611 | United States |
| Clinical Study Site | Recruiting | Edwardsville | Illinois | 62025 | United States |
| Clinical Study Site | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Clinical Study Site | Recruiting | Kansas City | Kansas | 66160 | United States |
| Clinical Study Site | Recruiting | Burlington | Massachusetts | 01805 | United States |
| Clinical Study Site | Recruiting | East Lansing | Michigan | 48824 | United States |
| Clinical Study Site | Recruiting | Omaha | Nebraska | 68198 | United States |
| Cinical Study Site | Recruiting | Lebanon | New Hampshire | 03766 | United States |
| Clinical Study Site | Recruiting | New York | New York | 10021 | United States |
| Clinical Study Site | Recruiting | New York | New York | 10032 | United States |
| Clinical Study Site | Recruiting | Cincinnati | Ohio | 45219 | United States |
| Clinical Study Site | Recruiting | Columbus | Ohio | 43221 | United States |
| Clinical Study Site | Recruiting | Portland | Oregon | 97239 | United States |
| Cinical Study Site | Recruiting | Nashville | Tennessee | 37232 | United States |
| Clinical Study Site | Recruiting | Dallas | Texas | 75243 | United States |
| Clinical Study Site | Recruiting | Denton | Texas | 76208 | United States |
| Cinical Study Site | Recruiting | Houston | Texas | 77030 | United States |
| Texas Locations | Recruiting | Houston | Texas | 77054 | United States |
| Clinical Study Site | Recruiting | Round Rock | Texas | 78681 | United States |
| Clinical Study Site | Recruiting | Sugar Land | Texas | 77478 | United States |
| Clinical Study Site | Recruiting | Seattle | Washington | 98195 | United States |
| Cinical Study Site | Recruiting | Buenos Aires | Buenos Aires | Argentina |
| Cinical Study Site | Recruiting | Rosario | Santa Fe Province | Argentina |
| Cinical Study Site #3 | Recruiting | Buenos Aires | Argentina |
| Cinical Study Site #4 | Recruiting | Buenos Aires | Argentina |
| Clinical Study Site #2 | Recruiting | Buenos Aires | Argentina |
| Clinical Study Site | Recruiting | Buenos Aires | Argentina |
| Cinical Study Site #2 | Recruiting | San Miguel de Tucumán | Argentina |
| Clinical Study Site | Recruiting | San Miguel de Tucumán | Argentina |
| Cinical Study Site | Recruiting | Liverpool | New South Wales | Australia |
| Clinical Study Site | Recruiting | Randwick | New South Wales | 2031 | Australia |
| Cinical Study Site | Recruiting | Saint Leonards | New South Wales | 2065 | Australia |
| Cinical Study Site | Recruiting | Sydney | New South Wales | 2033 | Australia |
| Cinical Study Site | Recruiting | Southport | Queensland | 4215 | Australia |
| Clinical Study Site | Recruiting | Melbourne | Victoria | 3004 | Australia |
| Cinical Study Site | Recruiting | Anderlecht | Brussels Capital | Belgium |
| Cinical Study Site | Recruiting | Brussels | Belgium |
| Cinical Study Site | Recruiting | Rio de Janeiro | Rio de Janeiro | 20551-030 | Brazil |
| Clinical Study Site | Recruiting | Campinas | São Paulo | Brazil |
| Cinical Study Site | Recruiting | Natal | Brazil |
| Cinical Study Site | Recruiting | Porto Alegre | 90610-000 | Brazil |
| Cinical Study Site | Recruiting | Salvador | 40290-000 | Brazil |
| Cinical Study Site | Recruiting | São Paulo | 04038 | Brazil |
| Cinical Study Site | Recruiting | São Paulo | 05403-000 | Brazil |
| Cinical Study Site | Recruiting | Sofia | Bulgaria |
| Clinical Study Site | Recruiting | Sofia | Bulgaria |
| Clinical Study Site | Recruiting | Hefei | Anhui | 230001 | China |
| Clinical Study Site | Recruiting | Guangzhou | Guangdong | 510080 | China |
| Clinical Study Site | Recruiting | Changsha | Hu'Nan | 410008 | China |
| Clinical Study Site | Recruiting | Changsha | Hu'Nan | 410013 | China |
| Clinical Study Site | Recruiting | Wuhan | Hubei | 430060 | China |
| Clinical Study Site | Recruiting | Chifeng | Inner Mongolia | 024050 | China |
| Clinical Study Site | Recruiting | Suzhou | Jiangsu | 215006 | China |
| Clinical Study Site | Recruiting | Beijing | 100034 | China |
| Clinical Study Site | Recruiting | Beijing | 100191 | China |
| Clinical Study Site | Recruiting | Chengdu | 610072 | China |
| Clinical Study Site | Recruiting | Fujian | 350001 | China |
| Clinical Study Site | Recruiting | Guangdong | 510180 | China |
| Clinical Study Site | Recruiting | Guangzhou | 510515 | China |
| Clinical Study Site | Recruiting | Jilin City | 130021 | China |
| Clinical Study Site | Recruiting | Shanghai | 200031 | China |
| Clinical Study Site | Recruiting | Shanghai | 200040 | China |
| Clinical Study Site | Recruiting | Sichuan | 610072 | China |
| Clinical Study Site | Recruiting | Taiyuan | China |
| Clinical Study Site | Recruiting | Wuhan | China |
| Cinical Study Site | Recruiting | Medellín | Antioquia | Colombia |
| Cinical Study Site | Recruiting | Antioquia | Colombia |
| Cinical Study Site | Recruiting | Medellín | Colombia |
| Cinical Study Site | Recruiting | Osijek | Croatia |
| Clinical Study Site | Recruiting | Aarhus | 8200 | Denmark |
| Clinical Study Site | Recruiting | Copenhagen | Denmark |
| Clinical Study Site | Recruiting | Bordeaux | 33000 | France |
| Cinical Study Site | Recruiting | Brest | 29200 | France |
| Clinical Study Site | Recruiting | Bron | 69500 | France |
| Clinical Study Site | Recruiting | Clermont-Ferrand | 63000 | France |
| Clinical Study Site | Recruiting | Libourne | 33500 | France |
| Clinical Study Site | Recruiting | Marseille | 13005 | France |
| Clinical Study Site | Recruiting | Nice | 06000 | France |
| Clinical Study Site | Recruiting | Paris | 75013 | France |
| Clinical Study Site | Recruiting | Paris | 75610 | France |
| Clinical Study Site | Recruiting | Strasbourg | 67200 | France |
| Cinical Study Site | Recruiting | Tours | 37000 | France |
| Clinical Study Site | Recruiting | Tours | 37000 | France |
| Clinical Study Site | Recruiting | Tbilisi | Georgia |
| Cinical Study Site | Recruiting | München | Bavaria | Germany |
| Clinical Study Site | Recruiting | Sande | Lower Saxony | 26452 | Germany |
| Clinical Study Site | Recruiting | Aachen | 52074 | Germany |
| Cinical Study Site | Recruiting | Greifswald | 17489 | Germany |
| Clinical Study Site | Recruiting | Rüdersdorf | 15562 | Germany |
| Clinical Study Site | Recruiting | Sande | 26452 | Germany |
| Cinical Study Site | Recruiting | Beersheba | Israel |
| Cinical Study Site | Recruiting | Haifa | 3109601 | Israel |
| Cinical Study Site | Recruiting | Safed | Israel |
| Clinical Study Site | Recruiting | Bergamo | 24127 | Italy |
| Clinical Study Site | Recruiting | Bologna | 40139 | Italy |
| Cinical Study Site | Recruiting | Genova | 16132 | Italy |
| Cinical Study Site | Recruiting | Gussago | 25064 | Italy |
| Cinical Study Site | Recruiting | Milan | 20126 | Italy |
| Cinical Study Site | Recruiting | Milan | Italy |
| Cinical Study Site | Recruiting | Modena | Italy |
| Clinical Study Site | Recruiting | Pavia | 27100 | Italy |
| Clinical Study Site | Recruiting | Ponderano | 13875 | Italy |
| Clinical Study Site | Recruiting | Roma | 00128 | Italy |
| Cinical Study Site | Recruiting | Roma | 00133 | Italy |
| Clinical Study Site #2 | Recruiting | Roma | 00189 | Italy |
| Clinical Study Site | Recruiting | Roma | Italy |
| Cinical Study Site | Recruiting | Terni | Italy |
| Cinical Study Site | Recruiting | Riga | LV-1002 | Latvia |
| Clinical Study Site | Recruiting | Riga | LV-1024 | Latvia |
| Cinical Study Site | Recruiting | Kota Kinabalu | Sabah | Malaysia |
| Cinical Study Site | Recruiting | Kuching | Sarawak | Malaysia |
| Cinical Study Site | Recruiting | George Town | 11700 | Malaysia |
| Cinical Study Site | Recruiting | Johor Bahru | 80100 | Malaysia |
| Cinical Study Site | Recruiting | Kota Kinabalu | Malaysia |
| Cinical Study Site | Recruiting | Kuala Lumpur | 50586 | Malaysia |
| Cinical Study Site | Recruiting | Kuala Lumpur | 50603 | Malaysia |
| Cinical Study Site | Recruiting | Kuala Lumpur | 56000 | Malaysia |
| Cinical Study Site | Recruiting | Kuching | Malaysia |
| Cinical Study Site | Recruiting | Sungai Buloh | Malaysia |
| Cinical Study Site | Recruiting | Amsterdam | Netherlands |
| Cinical Study Site | Recruiting | Utrecht | Netherlands |
| Clinical Study Site | Recruiting | Skopje | 1000 | North Macedonia |
| Cinical Study Site | Recruiting | Cebu City | Philippines |
| Cinical Study Site | Recruiting | City of Muntinlupa | Philippines |
| Cinical Study Site | Recruiting | Iloilo City | Philippines |
| Clinical Study Site | Recruiting | Bydgoszcz | 85-090 | Poland |
| Clinical Study Site | Recruiting | Krakow | 30-688 | Poland |
| Clinical Study Site | Recruiting | Lublin | 20-701 | Poland |
| Clinical Study Site | Recruiting | Lublin | 20-718 | Poland |
| Clinical Study Site | Recruiting | Lublin | 7763138 | Poland |
| Cinical Study Site | Recruiting | Warsaw | 04-141 | Poland |
| Clinical Study Site | Recruiting | Wroclaw | 50-367 | Poland |
| Clinical Study Site | Recruiting | Bucharest | 050474 | Romania |
| Cinical Study Site | Recruiting | Târgu Mureş | 540136 | Romania |
| Cinical Study Site | Recruiting | Belgrade | 11000 | Serbia |
| Clinical Study Site | Recruiting | Belgrade | 11000 | Serbia |
| Clinical Study Site | Recruiting | Kragujevac | 34000 | Serbia |
| Clinical Study Site | Recruiting | Niš | 18000 | Serbia |
| Cinical Study Site | Recruiting | Daegu | South Korea |
| Cinical Study Site | Recruiting | Daejeon | South Korea |
| Cinical Study Site #2 | Recruiting | Seoul | South Korea |
| Cinical Study Site #3 | Recruiting | Seoul | South Korea |
| Cinical Study Site | Recruiting | Seoul | South Korea |
| Cinical Study Site | Recruiting | Uijeongbu-si | South Korea |
| Cinical Study Site | Recruiting | Yangsan | South Korea |
| Clinical Study Site | Recruiting | Barcelona | Barcelona | 08916 | Spain |
| Clinical Study Site | Recruiting | Alicante | 03010 | Spain |
| Clinical Study Site | Recruiting | Barcelona | 08025 | Spain |
| Cinical Study Site | Recruiting | Barcelona | 08041 | Spain |
| Clinical Study Site | Recruiting | Bilbao | 48013 | Spain |
| Cinical Study Site #2 | Recruiting | Bangkok | Thailand |
| Cinical Study Site | Recruiting | Bangkok | Thailand |
| Cinical Study Site | Recruiting | Hat Yai | Thailand |
| Cinical Study Site | Recruiting | Khlong Luang | Thailand |
| Cinical Study Site | Recruiting | Khon Kaen | 40002 | Thailand |
| Cinical Study Site | Recruiting | Khon Kaen | Thailand |
| Cinical Study Site | Recruiting | Manchester | England | United Kingdom |
| Clinical Study Site | Recruiting | Oxford | United Kingdom |
| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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