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NCT06858579PHASE3Recruiting

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

Dianthus Therapeutics

Start Date

2/10/2025

Completion Date

12/31/2030

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).

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)

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

Claseprubart

DRUG

Claseprubart

DRUG

Placebo

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Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Locations

Clinical Study Site

Birmingham, Alabama 35294

United States

Clinical Study Site

Phoenix, Arizona 85028

United States

Clinical Study Site

Scottsdale, Arizona 85251'

United States

Clinical Study Site

Los Angeles, California 90048

United States

Clinical Study Site

San Francisco, California 94109

United States

Clinical Study Site

San Francisco, California 94158

United States

Cinical Study Site

New Haven, Connecticut 06520

United States

Clinical Study Site

Washington D.C., District of Columbia 20007

United States

Clinical Study Site

Maitland, Florida 32751

United States

Clinical Study Site

Tampa, Florida 33620

United States

Clinical Study Site

Honolulu, Hawaii 96817

United States

Clinical Study Site

Chicago, Illinois 60611

United States

Clinical Study Site

Edwardsville, Illinois 62025

United States

Clinical Study Site

Indianapolis, Indiana 46202

United States

Clinical Study Site

Kansas City, Kansas 66160

United States

Clinical Study Site

Burlington, Massachusetts 01805

United States

Clinical Study Site

East Lansing, Michigan 48824

United States

Clinical Study Site

Omaha, Nebraska 68198

United States

Cinical Study Site

Lebanon, New Hampshire 03766

United States

Clinical Study Site

New York, New York 10021

United States

Clinical Study Site

New York, New York 10032

United States

Clinical Study Site

Cincinnati, Ohio 45219

United States

Clinical Study Site

Columbus, Ohio 43221

United States

Clinical Study Site

Portland, Oregon 97239

United States

Cinical Study Site

Nashville, Tennessee 37232

United States

Clinical Study Site

Dallas, Texas 75243

United States

Clinical Study Site

Denton, Texas 76208

United States

Cinical Study Site

Houston, Texas 77030

United States

Texas Locations

Houston, Texas 77054

United States

Clinical Study Site

Round Rock, Texas 78681

United States

Clinical Study Site

Sugar Land, Texas 77478

United States

Clinical Study Site

Seattle, Washington 98195

United States

Cinical Study Site

Buenos Aires, Buenos Aires

Argentina

Cinical Study Site

Rosario, Santa Fe Province

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

Cinical Study Site

Liverpool, New South Wales

Australia

Clinical Study Site

Randwick, New South Wales 2031

Australia

Cinical Study Site

Saint Leonards, New South Wales 2065

Australia

Cinical Study Site

Sydney, New South Wales 2033

Australia

Cinical Study Site

Southport, Queensland 4215

Australia

Clinical Study Site

Melbourne, Victoria 3004

Australia

Cinical Study Site

Anderlecht, Brussels Capital

Belgium

Cinical Study Site

Brussels,

Belgium

Cinical Study Site

Rio de Janeiro, Rio de Janeiro 20551-030

Brazil

Clinical Study Site

Campinas, São Paulo

Brazil

Cinical Study Site

Natal,

Brazil

Cinical Study Site

Porto Alegre, 90610-000

Brazil

Cinical Study Site

Salvador, 40290-000

Brazil

Cinical Study Site

São Paulo, 04038

Brazil

Cinical Study Site

São Paulo, 05403-000

Brazil

Cinical Study Site

Sofia,

Bulgaria

Clinical Study Site

Sofia,

Bulgaria

Clinical Study Site

Hefei, Anhui 230001

China

Clinical Study Site

Guangzhou, Guangdong 510080

China

Clinical Study Site

Changsha, Hu'Nan 410008

China

Clinical Study Site

Changsha, Hu'Nan 410013

China

Clinical Study Site

Wuhan, Hubei 430060

China

Clinical Study Site

Chifeng, Inner Mongolia 024050

China

Clinical Study Site

Suzhou, Jiangsu 215006

China

Clinical Study Site

Beijing, 100034

China

Clinical Study Site

Beijing, 100191

China

Clinical Study Site

Chengdu, 610072

China

Clinical Study Site

Fujian, 350001

China

Clinical Study Site

Guangdong, 510180

China

Clinical Study Site

Guangzhou, 510515

China

Clinical Study Site

Jilin City, 130021

China

Clinical Study Site

Shanghai, 200031

China

Clinical Study Site

Shanghai, 200040

China

Clinical Study Site

Sichuan, 610072

China

Clinical Study Site

Taiyuan,

China

Clinical Study Site

Wuhan,

China

Cinical Study Site

Medellín, Antioquia

Colombia

Cinical Study Site

Antioquia,

Colombia

Cinical Study Site

Medellín,

Colombia

Cinical Study Site

Osijek,

Croatia

Clinical Study Site

Aarhus, 8200

Denmark

Clinical Study Site

Copenhagen,

Denmark

Clinical Study Site

Bordeaux, 33000

France

Cinical Study Site

Brest, 29200

France

Clinical Study Site

Bron, 69500

France

Clinical Study Site

Clermont-Ferrand, 63000

France

Clinical Study Site

Libourne, 33500

France

Clinical Study Site

Marseille, 13005

France

Clinical Study Site

Nice, 06000

France

Clinical Study Site

Paris, 75013

France

Clinical Study Site

Paris, 75610

France

Clinical Study Site

Strasbourg, 67200

France

Cinical Study Site

Tours, 37000

France

Clinical Study Site

Tours, 37000

France

Clinical Study Site

Tbilisi,

Georgia

Cinical Study Site

München, Bavaria

Germany

Clinical Study Site

Sande, Lower Saxony 26452

Germany

Clinical Study Site

Aachen, 52074

Germany

Cinical Study Site

Greifswald, 17489

Germany

Clinical Study Site

Rüdersdorf, 15562

Germany

Clinical Study Site

Sande, 26452

Germany

Cinical Study Site

Beersheba,

Israel

Cinical Study Site

Haifa, 3109601

Israel

Cinical Study Site

Safed,

Israel

Clinical Study Site

Bergamo, 24127

Italy

Clinical Study Site

Bologna, 40139

Italy

Cinical Study Site

Genova, 16132

Italy

Cinical Study Site

Gussago, 25064

Italy

Cinical Study Site

Milan, 20126

Italy

Cinical Study Site

Milan,

Italy

Cinical Study Site

Modena,

Italy

Clinical Study Site

Pavia, 27100

Italy

Clinical Study Site

Ponderano, 13875

Italy

Clinical Study Site

Roma, 00128

Italy

Cinical Study Site

Roma, 00133

Italy

Clinical Study Site #2

Roma, 00189

Italy

Clinical Study Site

Roma,

Italy

Cinical Study Site

Terni,

Italy

Cinical Study Site

Niigata, Chubu

Japan

Cinical Study Site

Kawasaki, Kanto

Japan

Cinical Study Site

Tsukuba, Kanto

Japan

Cinical Study Site

Kawagoe, Saitama

Japan

Cinical Study Site

Riga, LV-1002

Latvia

Clinical Study Site

Riga, LV-1024

Latvia

Cinical Study Site

Kota Kinabalu, Sabah

Malaysia

Cinical Study Site

Kuching, Sarawak

Malaysia

Cinical Study Site

George Town, 11700

Malaysia

Cinical Study Site

Johor Bahru, 80100

Malaysia

Cinical Study Site

Kota Kinabalu,

Malaysia

Cinical Study Site

Kuala Lumpur, 50586

Malaysia

Cinical Study Site

Kuala Lumpur, 50603

Malaysia

Cinical Study Site

Kuala Lumpur, 56000

Malaysia

Cinical Study Site

Kuching,

Malaysia

Cinical Study Site

Sungai Buloh,

Malaysia

Cinical Study Site

Amsterdam,

Netherlands

Cinical Study Site

Utrecht,

Netherlands

Clinical Study Site

Skopje, 1000

North Macedonia

Cinical Study Site

Batangas,

Philippines

Cinical Study Site

Cebu City,

Philippines

Cinical Study Site

City of Muntinlupa,

Philippines

Cinical Study Site

Iloilo City,

Philippines

Clinical Study Site

Bydgoszcz, 85-090

Poland

Clinical Study Site

Krakow, 30-688

Poland

Cinical Study Site

Lodz, 90-324

Poland

Clinical Study Site

Lublin, 20-701

Poland

Clinical Study Site

Lublin, 20-718

Poland

Clinical Study Site

Lublin, 7763138

Poland

Cinical Study Site

Warsaw, 04-141

Poland

Clinical Study Site

Wroclaw, 50-367

Poland

Clinical Study Site

Bucharest, 050474

Romania

Cinical Study Site

Târgu Mureş, 540136

Romania

Cinical Study Site

Belgrade, 11000

Serbia

Clinical Study Site

Belgrade, 11000

Serbia

Clinical Study Site

Kragujevac, 34000

Serbia

Clinical Study Site

Niš, 18000

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

Uijeongbu-si,

South Korea

Cinical Study Site

Yangsan,

South Korea

Clinical Study Site

Barcelona, Barcelona 08916

Spain

Clinical Study Site

Alicante, 03010

Spain

Clinical Study Site

Barcelona, 08025

Spain

Cinical Study Site

Barcelona, 08041

Spain

Clinical Study Site

Bilbao, 48013

Spain

Cinical Study Site

Bangkok, 10400

Thailand

Cinical Study Site #2

Bangkok,

Thailand

Cinical Study Site

Bangkok,

Thailand

Cinical Study Site

Chiang Mai, 50200

Thailand

Cinical Study Site

Hat Yai,

Thailand

Cinical Study Site

Khlong Luang,

Thailand

Cinical Study Site

Khon Kaen, 40002

Thailand

Cinical Study Site

Khon Kaen,

Thailand

Cinical Study Site

Bursa,

Turkey (Türkiye)

Cinical Study Site

Istanbul,

Turkey (Türkiye)

Cinical Study Site

Samsun,

Turkey (Türkiye)

Cinical Study Site

Manchester, England

United Kingdom

Clinical Study Site

Oxford,

United Kingdom