Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)

Recruiting · NCT06711887 · Interventional (participants receive a specific treatment) · Lead sponsor: Novartis Pharmaceuticals

Interventions studied

What this trial is about

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.

Who can take part

Where it is running

47 locations listed across 1 US state.

• Circuit Clinical - Orchard Park, New York, United States
• Novartis Investigative Site - Bangkok, Thailand
• Novartis Investigative Site - Bangkok, Thailand
• Novartis Investigative Site - Bangkok, Thailand
• Novartis Investigative Site - Barcelona, Spain
• Novartis Investigative Site - Beijing, China
• Novartis Investigative Site - Bucharest, Romania
• Novartis Investigative Site - Budapest, Hungary
• Novartis Investigative Site - Chiang Mai, Thailand
• Novartis Investigative Site - Chongqing, China
• Novartis Investigative Site - Grenoble, France
• Novartis Investigative Site - Guangzhou, China
• Novartis Investigative Site - Guangzhou, China
• Novartis Investigative Site - Guatemala City, Guatemala
• Novartis Investigative Site - Oaxaca City, Mexico
• Novartis Investigative Site - Olomouc, Czechia
• Novartis Investigative Site - Prague, Czechia
• Novartis Investigative Site - Querétaro, Mexico
• Novartis Investigative Site - Seoul, South Korea
• Novartis Investigative Site - Seoul, South Korea
• Novartis Investigative Site - Seoul, South Korea
• Novartis Investigative Site - Shanghai, China
• Novartis Investigative Site - Singapore, Singapore
• Novartis Investigative Site - Taichung, Taiwan
• Novartis Investigative Site - Tuenmen, Hong Kong
• Novartis Investigative Site - Barranquilla, Atlántico, Colombia
• Novartis Investigative Site - Guatemala City, Departamento de Guatemala, Guatemala
• Novartis Investigative Site - Quetzaltenango, Departamento de Quetzaltenango, Guatemala
• Novartis Investigative Site - Vitória, Espírito Santo, Brazil
• Novartis Investigative Site - Salvador, Estado de Bahia, Brazil
• Novartis Investigative Site - León, Guanajuato, Mexico
• 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 - Suwon, Gyeonggi-do, South Korea
• Novartis Investigative Site - Songkhla, Hat Yai, Thailand
• Novartis Investigative Site - Wuhan, Hubei, China
• Novartis Investigative Site - Changchun, Jilin, China
• Novartis Investigative Site - Kuala Lumpur, Kuala Lumpur, Malaysia
• Novartis Investigative Site - Belo Horizonte, Minas Gerais, Brazil
• Novartis Investigative Site - Recife, Pernambuco, Brazil
• Novartis Investigative Site - Sibu, Sarawak, Malaysia
• Novartis Investigative Site - Binzhou, Shandong, China
• Novartis Investigative Site - Singapore, Singapore, Singapore
• Novartis Investigative Site - Santo André, São Paulo, Brazil
• Novartis Investigative Site - Ho Chi Minh City, VNM, Vietnam