Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)
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)
- Lupus Nephritis
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Novartis Pharmaceuticals
- Enrolment target
- 348
- Started
- 19 May 2025
- Main results due
- 1 August 2035
- Study sites
- 51
- Registry updated
- 28 September 2026
Can you take part?
- Ages 18 years to 100 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: 1. Signed informed consent prior to participation in the extension study. 2. Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment. Exclusion Criteria: 1. Use of prohibited therapies 2. Pregnant or nursing (lactating) women.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(51)
Circuit Clinical
Orchard Park, New York, United States
Recruiting
Novartis Investigative Site
Vitória, Espírito Santo, Brazil
Recruiting
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil
Recruiting
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil
Recruiting
Novartis Investigative Site
Recife, Pernambuco, Brazil
Recruiting
Novartis Investigative Site
Santo André, São Paulo, Brazil
Recruiting
Novartis Investigative Site
Guangzhou, Guangdong, China
Recruiting
Novartis Investigative Site
Shantou, Guangdong, China
Active, not recruiting
Novartis Investigative Site
Shenzhen, Guangdong, China
Recruiting
Novartis Investigative Site
Liuzhou, Guangxi, China
Recruiting
Novartis Investigative Site
Wuhan, Hubei, China
Recruiting
Novartis Investigative Site
Changchun, Jilin, China
Recruiting
Novartis Investigative Site
Shenyang, Liaoning, China
Recruiting
Novartis Investigative Site
Binzhou, Shandong, China
Recruiting
Novartis Investigative Site
Ningbo, Zhejiang, China
Recruiting
Novartis Investigative Site
Beijing, China
Recruiting
Novartis Investigative Site
Chongqing, China
Recruiting
Novartis Investigative Site
Guangzhou, China
Recruiting
Novartis Investigative Site
Guangzhou, China
Recruiting
Novartis Investigative Site
Shanghai, China
Recruiting
Novartis Investigative Site
Shanghai, China
Recruiting
Novartis Investigative Site
Medellín, Antioquia, Colombia
Recruiting
Novartis Investigative Site
Barranquilla, Atlántico, Colombia
Recruiting
Novartis Investigative Site
Olomouc, Czechia
Active, not recruiting
Novartis Investigative Site
Prague, Czechia
Recruiting
Novartis Investigative Site
Grenoble, France
Recruiting
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, Guatemala
Recruiting
Novartis Investigative Site
Quetzaltenango, Departamento de Quetzaltenango, Guatemala
Recruiting
Novartis Investigative Site
Guatemala City, Guatemala
Recruiting
Novartis Investigative Site
Tuenmen, Hong Kong
Recruiting
Novartis Investigative Site
Budapest, Hungary
Recruiting
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, Malaysia
Recruiting
Novartis Investigative Site
Sibu, Sarawak, Malaysia
Recruiting
Novartis Investigative Site
León, Guanajuato, Mexico
Recruiting
Novartis Investigative Site
Oaxaca City, Mexico
Recruiting
Novartis Investigative Site
Querétaro, Mexico
Recruiting
Novartis Investigative Site
Bucharest, Romania
Recruiting
Novartis Investigative Site
Singapore, Singapore, Singapore
Recruiting
Novartis Investigative Site
Singapore, Singapore
Recruiting
Novartis Investigative Site
Suwon, Gyeonggi-do, South Korea
Recruiting
Novartis Investigative Site
Seoul, South Korea
Recruiting
Novartis Investigative Site
Seoul, South Korea
Recruiting
Novartis Investigative Site
Seoul, South Korea
Recruiting
Novartis Investigative Site
Barcelona, Spain
Recruiting
Novartis Investigative Site
Taichung, Taiwan
Recruiting
Novartis Investigative Site
Songkhla, Hat Yai, Thailand
Recruiting
Novartis Investigative Site
Bangkok, Thailand
Recruiting
Novartis Investigative Site
Bangkok, Thailand
Recruiting
Novartis Investigative Site
Bangkok, Thailand
Recruiting
Novartis Investigative Site
Chiang Mai, Thailand
Recruiting
Novartis Investigative Site
Ho Chi Minh City, VNM, Vietnam
Recruiting
Showing 51 of 51 sites. 49 of the 51 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06711887. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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