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Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
Sponsor: Novartis Pharmaceuticals
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).
Official title: A Randomized, Double-blind, Placebo-controlled Extension Study, Followed by a Study Treatment Withdrawal or Open-label Period, to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)
Key Details
Gender
All
Age Range
12 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
550
Start Date
2024-05-21
Completion Date
2034-10-02
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Placebo
Placebo s.c. monthly
Ianalumab
Ianalumab s.c. monthly Ianalumab s.c. quarterly
Locations (164)
Pinnacle Research Group Llc
Anniston, Alabama, United States
Providence Medical Center
Burbank, California, United States
Advanced Medical Research
La Palma, California, United States
Millennium Clinical Trials
Westlake Village, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Clinical Res Of W Florida
Clearwater, Florida, United States
GNP Research
Cooper City, Florida, United States
Homestead Assoc In Research Inc
Homestead, Florida, United States
IRIS Research and Development
Plantation, Florida, United States
Clinical Research of West Florida Inc
Tampa, Florida, United States
Parris and Associates Rheumatology
Lawrenceville, Georgia, United States
Robert A Hozman MD SC
Skokie, Illinois, United States
Willow Rheumatology Wellness
Willowbrook, Illinois, United States
Accurate Clinical Research
Lake Charles, Louisiana, United States
UMC New Orleans
New Orleans, Louisiana, United States
University Of Maryland
Baltimore, Maryland, United States
Henry Ford Health
Detroit, Michigan, United States
Ahmed Arif Medical Research Center
Grand Blanc, Michigan, United States
Paramount Med Rsrch and Consult LLC
Middleburg Heights, Ohio, United States
University Of Pittsburgh
Pittsburgh, Pennsylvania, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Shelby Research LLC
Memphis, Tennessee, United States
Novel Research LLC
Bellaire, Texas, United States
Accurate Clinical Research
League City, Texas, United States
Epic Medical Research
Red Oak, Texas, United States
Novartis Investigative Site
La Plata, Buenos Aires, Argentina
Novartis Investigative Site
Quilmes, Buenos Aires, Argentina
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San Miguel, Buenos Aires, Argentina
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San Miguel, Tucumán Province, Argentina
Novartis Investigative Site
Caba, Argentina
Novartis Investigative Site
Caba, Argentina
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San Miguel de Tucumán, Argentina
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Maroochydore, Queensland, Australia
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Vitória, Espírito Santo, Brazil
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil
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Belo Horizonte, Minas Gerais, Brazil
Novartis Investigative Site
Niterói, Rio de Janeiro, Brazil
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, Brazil
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Barretos, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Salvador, Brazil
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Plovdiv, Bulgaria, Bulgaria
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Sofia, Bulgaria
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Vancouver, British Columbia, Canada
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Toronto, Ontario, Canada
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Rimouski, Quebec, Canada
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Valdivia, Los Ríos Region, Chile
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Santiago, RM, Chile
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Santiago, Santiago Metropolitan, Chile
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Guangzhou, Guangdong, China
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Guangzhou, Guangdong, China
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Shantou, Guangdong, China
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Nanjing, Jiangsu, China
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Suzhou, Jiangsu, China
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Nanchang, Jiangxi, China
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Pingxiang, Jiangxi, China
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Changchun, Jilin, China
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Linyi, Shandong, China
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Chengdu, Sichuan, China
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Ürümqi, Xinjiang, China
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Ningbo, Zhejiang, China
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Wenzhou, Zhejiang, China
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Beijing, China
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Beijing, China
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Shanghai, China
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Xinxiang, China
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Medellín, Antioquia, Colombia
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Barranquilla, Atlántico, Colombia
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Chía, Cundinamarca, Colombia
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Bucaramanga, Santander Department, Colombia
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Cali, Valle del Cauca Department, Colombia
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Bogotá, Colombia
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Brno, Czechia
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Prague, Czechia
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Uherské Hradiště, Czechia
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Montpellier, France
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Paris, France
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Paris, France
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Toulouse, France
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Toulouse, France
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Cologne, North Rhine-Westphalia, Germany
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Leipzig, Saxony, Germany
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Guatemala City, Departamento de Guatemala, Guatemala
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Guatemala City, Guatemala
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Székesfehérvár, Fejér, Hungary
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Budapest, Hungary
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Gyula, Hungary
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Zalaegerszeg, Hungary
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Ahmedabad, Gujarat, India
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Ahmedabad, Gujarat, India
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Kozhikode, Kerala, India
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Kolhāpur, Maharashtra, India
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Nagpur, Maharashtra, India
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Nashik, Maharashtra, India
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Pune, Maharashtra, India
Novartis Investigative Site
Pune, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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New Delhi, New Delhi, India
Novartis Investigative Site
New Delhi, India