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