A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
Start Date
10/9/2024
Completion Date
7/31/2034
Summary
The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo
Detailed Description
The study consists of the following periods: * Screening Period, with a duration of up to 6 weeks; * Treatment Period 1, with a duration of 52 weeks; * Treatment Period 2 (Open-label treatment), with a duration of 52 weeks; * Post-treatment Follow-up Period, with a duration of at least 20 weeks post last dose and up to 2 years.
Eligibility Criteria
Age Range: 18 years to 70 years
Interventions
Placebo
Ianalumab
Conditions
Locations
Arizona Arthritis and Rheumatology Research PLLC
Mesa, Arizona 85202
United States
UCLA
Los Angeles, California 90095
United States
Hoag Hospital
Newport Beach, California 92663
United States
Clinical Res Of W Florida
Clearwater, Florida 33765
United States
GNP Research
Cooper City, Florida 33024
United States
IRIS Research and Development
Plantation, Florida 33324
United States
Sarasota Arthritis Res Ctr
Sarasota, Florida 34239
United States
University of Chicago Hospitals
Chicago, Illinois 60637
United States
UMC New Orleans
New Orleans, Louisiana 70112
United States
Uni Of Michigan Health System
Ann Arbor, Michigan 48109
United States
Wayne State University
Detroit, Michigan 48201
United States
Clinical Research Inst of MI
Saint Clair Shores, Michigan 48081
United States
Hospital for Special Surgery
New York, New York 10021
United States
West Tennessee Research Institute
Jackson, Tennessee 38305
United States
Arthritis and Rheumatology Ins
Allen, Texas 75035
United States
Novel Research LLC
Bellaire, Texas 77401
United States
Prolato Clinical Research Center
Houston, Texas 77054
United States
Novartis Investigative Site
CABA, Buenos Aires C1221ADC
Argentina
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CABA, Buenos Aires C1280AEB
Argentina
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Caba, C1015ABO
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Caba, C1427CCL
Argentina
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San Miguel de Tucumán, T4000AXL
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Graz, 8036
Austria
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Leuven, 3000
Belgium
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Salvador, Estado de Bahia 40150 150
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Curitiba, Paraná 80030-110
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Porto Alegre, Rio Grande do Sul 90035-074
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Sao Jose Rio Preto, São Paulo 15090 000
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São Paulo, São Paulo 04038-002
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São Paulo, São Paulo 05403-000
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Nanning, Guangxi 530021
China
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Zhengzhou, Henan 450003
China
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Changchun, Jilin 130021
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Chengdu, Sichuan 610041
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Ningbo, Zhejiang 315016
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Beijing, 100191
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Beijing, 100730
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Tianjin, 300052
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Medellín, Antioquia 050001
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Bogota, Cundinamarca 110111
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Bogota, Cundinamarca 110221
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Cali, Valle del Cauca Department 760012
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Bogotá, 110231
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Medellín, 050034
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Dijon, 21000
France
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Le Mans, 72000
France
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Lille, 59037
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Montpellier, 34295
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Paris, 75014
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Rennes, 35033
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Strasbourg, 67000
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Toulouse, 31054
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Würzburg, Bavaria 97080
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Jena, Thuringia 07740
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Berlin, 13353
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Alexandroupoli, 681 00
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Athens, 115 21
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Athens, 115 27
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Pécs, Baranya 7623
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Debrecen, Hajdu Bihar Megye 4032
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Budapest, H-1083
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Kochi, Kerala 682018
India
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Mumbai, Maharashtra 400013
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Mumbai, Maharashtra 400078
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New Delhi, National Capital Territory of Delhi 110060
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New Delhi, New Delhi 110029
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Jaipur, Rajasthan 302004
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Ancona, AN 60020
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Milan, MI 20100
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Rozzano, MI 20089
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Modena, MO 41124
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Palermo, PA 90127
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Pavia, PV 27100
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Roma, RM 00168
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Verona, VR 37134
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Nagoya, Aichi-ken 4578510
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Toyoake, Aichi-ken 4701192
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Kitakyushu, Fukuoka 8078556
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Maebashi, Gunma 3718511
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Sapporo, Hokkaido 060-8648
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Sapporo, Hokkaido 0608543
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Yokohama, Kanagawa 236-0004
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Suita, Osaka 565-0871
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Iruma-gun, Saitama 3500495
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Bunkyo-ku, Tokyo 113-8603
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Chuo Ku, Tokyo 104-8560
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Shinjuku Ku, Tokyo 1628666
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Shinjuku-ku, Tokyo 1608582
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Toyama, Toyama 9300194
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Fukuoka, 8128582
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Hiroshima, 7348551
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Ishikawa, 9208641
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Kyoto, 6068507
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Cheras, Kuala Lumpur 56000
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Kuala Lumpur, 59100
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Chihuahua City, Chihuahua 31000
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Guadalajara, Jalisco 44650
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Mexico City, Mexico City 06700
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Mexico City, Mexico City 11850
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Monterrey, Nuevo León 64460
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Bydgoszcz, 85-168
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Warsaw, 00-874
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Coimbra, 3004-561
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Lisbon, 1649-035
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Vila Nova de Gaia, 4434 502
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Seoul, Seoul 03080
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Busan, 49241
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Seoul, 04763
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Seoul, 06273
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Málaga, Andalusia 29009
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Valencia, Valencia 46017
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Barcelona, 08041
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Madrid, 28009
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Salamanca, 37007
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Changhua, 50006
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Kaohsiung City, 833
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Taichung, 40447
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Taoyuan, 33305
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Khon Kaen, THA 40002
Thailand
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Bangkok, 10400
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Istanbul, Fatih 34093
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Ankara, Sihhiye-Altindag 06230
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Ankara, Yenimahalle 06500
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Basingstoke, Hampshire RG24 9NA
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Bristol, BS10 5NB
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London, NW3 2QG
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Ho Chi Minh City, VNM 700000
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Ho Chi Minh City, 700000
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