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Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety 1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \[CRR\] or partial renal response \[PRR\]) on double-blind treatment at the end of the SIRIUS-LN core study, and 2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR/PRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.
Official title: An Open-label Extension Study to Assess the Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Adult Participants With Lupus Nephritis Who Have Completed Study Treatment in the CVAY736K12301 Core Study (SIRIUS-LN Extension)
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
348
Start Date
2025-05-19
Completion Date
2035-08-01
Last Updated
2026-07-10
Healthy Volunteers
No
Conditions
Interventions
Ianalumab
Ianalumab (VAY736) is a human monoclonal antibody (mAb) of the IgG1/κ-class, directed against B cells and binding to BAFF receptor (BAFF-R).
Locations (41)
Circuit Clinical
Orchard Park, New York, United States
Novartis Investigative Site
Vitória, Espírito Santo, Brazil
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil
Novartis Investigative Site
Santo André, São Paulo, Brazil
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Shantou, Guangdong, China
Novartis Investigative Site
Shenzhen, Guangdong, China
Novartis Investigative Site
Liuzhou, Guangxi, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Binzhou, Shandong, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Chongqing, China
Novartis Investigative Site
Guangzhou, China
Novartis Investigative Site
Guangzhou, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Barranquilla, Atlántico, Colombia
Novartis Investigative Site
Olomouc, Czechia
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Guatemala City, Guatemala
Novartis Investigative Site
Guatemala City, Guatemala
Novartis Investigative Site
Tuenmen, Hong Kong
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, Malaysia
Novartis Investigative Site
Sibu, Sarawak, Malaysia
Novartis Investigative Site
León, Guanajuato, Mexico
Novartis Investigative Site
Oaxaca City, Mexico
Novartis Investigative Site
Querétaro, Mexico
Novartis Investigative Site
Bucharest, Romania
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Suwon, Gyeonggi-do, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Taichung, Taiwan
Novartis Investigative Site
Songkhla, Hat Yai, Thailand
Novartis Investigative Site
Bangkok, Thailand
Novartis Investigative Site
Bangkok, Thailand
Novartis Investigative Site
Chiang Mai, Thailand