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

Description

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.

Interventions

• Ianalumab (Drug)
  Ianalumab (VAY736) is a human monoclonal antibody (mAb) of the IgG1/κ-class, directed against B cells and binding to BAFF receptor (BAFF-R).

Eligibility criteria

Conditions

Locations

• 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 — Recife, Pernambuco, 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 — Shenyang, Liaoning, China
• Novartis Investigative Site — Binzhou, Shandong, China
• Novartis Investigative Site — Ningbo, Zhejiang, 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 — Shanghai, China
• Novartis Investigative Site — Medellín, Antioquia, Colombia
• Novartis Investigative Site — Barranquilla, Atlántico, Colombia
• Novartis Investigative Site — Olomouc, Czechia
• Novartis Investigative Site — Prague, Czechia
• Novartis Investigative Site — Grenoble, France
• Novartis Investigative Site — Guatemala City, Departamento de Guatemala, Guatemala
• Novartis Investigative Site — Quetzaltenango, Departamento de Quetzaltenango, 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, 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 — 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 — Bangkok, Thailand
• Novartis Investigative Site — Chiang Mai, Thailand
• Novartis Investigative Site — Ho Chi Minh City, VNM, Vietnam