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Набира участници Фаза 3 NCT06858579

A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Chronic Inflammatory Demyelinating Polyneuropathy

Спонсор: Dianthus Therapeutics

Налично на: БГ
Обобщение
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).
Описание
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)
Кой може да участва
Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are carried out. 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 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: 1. Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP. 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.
Интервенции
Claseprubart
DRUG
Claseprubart
DRUG
Placebo
DRUG
Места на провеждане 158
Argentina (8)
Cinical Study Site #3
Buenos Aires
Cinical Study Site #4
Buenos Aires
Cinical Study Site
Buenos Aires
Clinical Study Site #2
Buenos Aires
Clinical Study Site
Buenos Aires
Cinical Study Site
Rosario , Santa Fe Province
Cinical Study Site #2
San Miguel de Tucumán
Clinical Study Site
San Miguel de Tucumán
Австралия (5)
Clinical Study Site
Melbourne , Victoria
Clinical Study Site
Randwick , New South Wales
Cinical Study Site
Saint Leonards , New South Wales
Cinical Study Site
Southport , Queensland
Cinical Study Site
Sydney , New South Wales
Белгия (1)
Cinical Study Site
Brussels
Бразилия (7)
Clinical Study Site
Campinas , São Paulo
Cinical Study Site
Natal
Cinical Study Site
Porto Alegre
Cinical Study Site
Rio de Janeiro
Cinical Study Site
Salvador
Cinical Study Site
São Paulo
Cinical Study Site
São Paulo
България (2)
Cinical Study Site
Sofia
Clinical Study Site
Sofia
Китай (19)
Clinical Study Site
Beijing
Clinical Study Site
Beijing
Clinical Study Site
Changsha , Hu'nan
Clinical Study Site
Changsha , Hu'nan
Clinical Study Site
Chengdu
Clinical Study Site
Chifeng , Inner Mongolia
Clinical Study Site
Fujian
Clinical Study Site
Guangdong
Clinical Study Site
Guangzhou , Guangdong
Clinical Study Site
Guangzhou
Clinical Study Site
Hefei , Anhui
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Jilin
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Shanghai
Clinical Study Site
Shanghai
Clinical Study Site
Sichuan
Clinical Study Site
Suzhou , Jiangsu
Clinical Study Site
Taiyuan
Clinical Study Site
Wuhan , Hubei
Clinical Study Site
Wuhan
Colombia (3)
Cinical Study Site
Antioquia
Cinical Study Site
Medellín
Cinical Study Site
Medellín , Antioquia
Хърватия (1)
Cinical Study Site
Osijek
Дания (2)
Clinical Study Site
Aarhus
Clinical Study Site
Copenhagen
Франция (12)
Clinical Study Site
Bordeaux
Cinical Study Site
Brest
Clinical Study Site
Bron
Clinical Study Site
Clermont-Ferrand
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Libourne
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Marseille
Clinical Study Site
Nice
Clinical Study Site
Paris
Clinical Study Site
Paris
Clinical Study Site
Strasbourg
Cinical Study Site
Tours
Clinical Study Site
Tours
Georgia (1)
Clinical Study Site
Tbilisi
Германия (5)
Clinical Study Site
Aachen
Cinical Study Site
Greifswald
Clinical Study Site
Rüdersdorf
Clinical Study Site
Sande , Lower Saxony
Clinical Study Site
Sande
Израел (3)
Cinical Study Site
Beersheba
Cinical Study Site
Haifa
Cinical Study Site
Safed
Италия (13)
Clinical Study Site
Bergamo
Clinical Study Site
Bologna
Cinical Study Site
Genova
Cinical Study Site
Gussago
Cinical Study Site
Milan
Cinical Study Site
Milan
Cinical Study Site
Modena
Clinical Study Site
Pavia
Clinical Study Site
Ponderano
Clinical Study Site
Roma
Clinical Study Site #2
Roma
Clinical Study Site
Roma
Cinical Study Site
Terni
Latvia (2)
Cinical Study Site
Riga
Clinical Study Site
Riga
Malaysia (10)
Cinical Study Site
George Town
Cinical Study Site
Johor Bahru
Cinical Study Site
Kota Kinabalu , Sabah
Cinical Study Site
Kota Kinabalu
Cinical Study Site
Kuala Lumpur
Cinical Study Site
Kuala Lumpur
Cinical Study Site
Kuala Lumpur
Cinical Study Site
Kuching , Sarawak
Cinical Study Site
Kuching
Cinical Study Site
Sungai Buloh
Нидерландия (1)
Cinical Study Site
Utrecht
North Macedonia (1)
Clinical Study Site
Skopje
Philippines (2)
Cinical Study Site
Cebu City
Cinical Study Site
Iloilo City
Полша (7)
Clinical Study Site
Bydgoszcz
Clinical Study Site
Krakow
Clinical Study Site
Lublin
Clinical Study Site
Lublin
Clinical Study Site
Lublin
Cinical Study Site
Warsaw
Clinical Study Site
Wroclaw
Румъния (1)
Clinical Study Site
Bucharest
Сърбия (4)
Cinical Study Site
Belgrade
Clinical Study Site
Belgrade
Clinical Study Site
Kragujevac
Clinical Study Site
Niš
Южна Корея (6)
Cinical Study Site
Daegu
Cinical Study Site
Daejeon
Cinical Study Site #2
Seoul
Cinical Study Site #3
Seoul
Cinical Study Site
Seoul
Cinical Study Site
Yangsan
Испания (5)
Clinical Study Site
Alicante
Clinical Study Site
Barcelona
Cinical Study Site
Barcelona
Clinical Study Site
Barcelona
Clinical Study Site
Bilbao
Тайланд (6)
Cinical Study Site #2
Bangkok
Cinical Study Site
Bangkok
Cinical Study Site
Hat Yai
Cinical Study Site
Khlong Luang
Cinical Study Site
Khon Kaen
Cinical Study Site
Khon Kaen
Великобритания (1)
Clinical Study Site
Oxford
САЩ (30)
Clinical Study Site
Birmingham , Alabama
Clinical Study Site
Burlington , Massachusetts
Clinical Study Site
Chicago , Illinois
Clinical Study Site
Cincinnati , Ohio
Clinical Study Site
Columbus , Ohio
Clinical Study Site
Dallas , Texas
Clinical Study Site
Denton , Texas
Clinical Study Site
East Lansing , Michigan
Clinical Study Site
Edwardsville , Illinois
Clinical Study Site
Honolulu , Hawaii
Cinical Study Site
Houston , Texas
Texas Locations
Houston , Texas
Clinical Study Site
Indianapolis , Indiana
Clinical Study Site
Kansas City , Kansas
Cinical Study Site
Lebanon , New Hampshire
Clinical Study Site
Los Angeles , California
Clinical Study Site
Maitland , Florida
Clinical Study Site
New York , New York
Clinical Study Site
New York , New York
Clinical Study Site
Omaha , Nebraska
Clinical Study Site
Phoenix , Arizona
Clinical Study Site
Portland , Oregon
Clinical Study Site
Round Rock , Texas
Clinical Study Site
San Francisco , California
Clinical Study Site
San Francisco , California
Clinical Study Site
Scottsdale , Arizona
Clinical Study Site
Seattle , Washington
Clinical Study Site
Sugar Land , Texas
Clinical Study Site
Tampa , Florida
Clinical Study Site
Washington D.C. , District of Columbia
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
10.02.2025
Крайна дата
31.12.2030
Регистрационен номер
NCT06858579
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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