Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
Start Date
5/21/2024
Completion Date
4/5/2032
Summary
The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).
Detailed Description
The purpose of this extension study is to evaluate long-term safety and tolerability of ianalumab administered s.c. monthly or quarterly, compared to monthly placebo, in adolescent and adult participants with anti-nuclear antibody (ANA)-positive systemic lupus erythematosus of moderate-to-severe disease activity, who have completed either CVAY736F12301 (SIRIUS-SLE 1) or CVAY736F12302 (SIRIUS-SLE 2) core studies.
Eligibility Criteria
Age Range: 12 years to 100 years
Interventions
Placebo
Ianalumab
Conditions
Locations
Pinnacle Research Group Llc
Anniston, Alabama 36207
United States
Providence Medical Center
Burbank, California 91505
United States
Advanced Medical Research
La Palma, California 90623
United States
Millennium Clinical Trials
Westlake Village, California 91361
United States
University of Colorado Denver
Aurora, Colorado 80045
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
Clinical Research of West Florida Inc
Tampa, Florida 33603
United States
Parris and Associates Rheumatology
Lawrenceville, Georgia 30044
United States
Robert A Hozman MD SC
Skokie, Illinois 60076
United States
Willow Rheumatology Wellness
Willowbrook, Illinois 60527
United States
Accurate Clinical Research
Lake Charles, Louisiana 70601
United States
University Of Maryland
Baltimore, Maryland 21201
United States
Henry Ford Health
Detroit, Michigan 48202
United States
Ahmed Arif Medical Research Center
Grand Blanc, Michigan 48439
United States
Paramount Med Rsrch and Consult LLC
Middleburg Heights, Ohio 44130
United States
West Tennessee Research Institute
Jackson, Tennessee 38305
United States
Shelby Research LLC
Memphis, Tennessee 38121
United States
Novel Research LLC
Bellaire, Texas 77401
United States
Accurate Clinical Research
League City, Texas 77573
United States
Epic Medical Research
Red Oak, Texas 75154
United States
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La Plata, Buenos Aires B1900AWT
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Quilmes, Buenos Aires 1878
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San Miguel, Buenos Aires B1663GKT
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San Miguel, Tucumán Province T4000CBC
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Caba, C1015ABO
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Caba, C1427CCL
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San Miguel de Tucumán, T4000AXL
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Maroochydore, Queensland 4558
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Salvador, Estado de Bahia 40150 150
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Belo Horizonte, Minas Gerais 30150-221
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Niterói, Rio de Janeiro 24020 096
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Rio de Janeiro, Rio de Janeiro 22211-230
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Barretos, São Paulo 14784 400
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São Paulo, São Paulo 01244-030
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São Paulo, São Paulo 04038-002
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Salvador, 40323-010
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Plovdiv, 4002
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Sofia, 1431
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Vancouver, British Columbia V5Z 1L7
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Rimouski, Quebec G5L 5T1
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Valdivia, Los Ríos Region 5110683
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Santiago, RM 7500588
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Santiago, Santiago Metropolitan 7500710
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Guangzhou, Guangdong 510080
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Shantou, Guangdong 515000
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Nanjing, Jiangsu 210008
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Suzhou, Jiangsu 215004
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Ürümqi, Xinjiang 830001
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Ningbo, Zhejiang 315016
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Beijing, 100069
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Beijing, 100730
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Xinxiang, 453099
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Barranquilla, Atlántico 080020
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Chía, Cundinamarca 250001
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Bucaramanga, Santander Department 680003
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Cali, Valle del Cauca Department 760046
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Bogotá, 111211
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Brno, 638 00
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Prague, 128 00
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Uherské Hradiště, 686 01
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Montpellier, 34295
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Paris, 75013
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Paris, 75014
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Toulouse, 31054
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Toulouse, 31059
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Cologne, North Rhine-Westphalia 50937
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Leipzig, Saxony 04103
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Guatemala City, 01010
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Gyula, 5700
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Zalaegerszeg, 8900
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Ahmedabad, Gujarat 380006
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Ahmedabad, Gujarat 380015
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Kozhikode, Kerala 673008
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Kolhāpur, Maharashtra 416001
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Nagpur, Maharashtra 441108
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Nashik, Maharashtra 422101
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Pune, Maharashtra 411001
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New Delhi, 110029
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New Delhi, 110075
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Haifa, 3109601
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Ramat Gan, 5265601
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Pisa, PI 56126
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Torino, TO 10128
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Nagoya, Aichi-ken 4578510
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Nagoya, Aichi-ken 4578511
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Sapporo, Hokkaido 060-8648
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Yokohama, Kanagawa 236-0004
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Bunkyo-ku, Tokyo 1138519
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Chuo Ku, Tokyo 104-8560
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Fuchū, Tokyo 1838524
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Shinjuku-ku, Tokyo 1608582
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León, Guanajuato 37160
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Guadalajara, Jalisco 44160
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Mexico City, Mexico City 06700
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Morelia, Michoacán 58000
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Mérida, Yucatán 97070
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México, 07760
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Bydgoszcz, 85-065
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Bydgoszcz, 85-168
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Bytom, 41 902
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Warsaw, 00-874
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Warsaw, 04-141
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Braga, 4710243
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Lisbon, 1050-034
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Cluj-Napoca, Cluj 400006
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Brasov, 500283
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Košice, 040 01
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Pretoria, Gauteng 0002
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Cape Town, Western Cape 7405
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Cape Town, Western Cape 7500
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Somerset West, Western Cape 7130
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Umhlanga, 4320
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Gwangju, 61469
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Seoul, 04763
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Seoul, 06591
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Santiago Compostela, A Coruna 15706
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Badalona, Barcelona 08916
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Santander, Cantabria 39008
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Barcelona, Catalonia 08003
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San Sebastian Reyes, Madrid 28702
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Barcelona, 08035
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Madrid, 28034
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Valencia, 46014
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Taichung, 40447
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Taichung, 407219
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Taipei, 11217
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Taoyuan, 33305
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Bangkok, 10400
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