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 now · Phase 3

Conditions studied: Lupus Nephritis

In brief

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.

Key facts

Study ID

NCT06711887

Run by

Novartis Pharmaceuticals

People needed

348

Starts

2025-05-19

Expected to finish

2035-08-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent prior to participation in the extension study.
• 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.

You may not qualify if…

• Use of prohibited therapies
• Pregnant or nursing (lactating) women.

Where it is running

• Novartis Investigative Site — Chiang Mai, Thailand (enrolling)
• Novartis Investigative Site — Vitória, Espírito Santo, Brazil (enrolling)
• Novartis Investigative Site — Salvador, Estado de Bahia, Brazil (enrolling)
• Novartis Investigative Site — Belo Horizonte, Minas Gerais, Brazil (enrolling)
• Novartis Investigative Site — Santo André, São Paulo, Brazil (enrolling)
• Novartis Investigative Site — Guangzhou, Guangdong, China (enrolling)
• Novartis Investigative Site — Bangkok, Thailand (enrolling)
• Circuit Clinical — Orchard Park, New York, United States (enrolling)
• Novartis Investigative Site — Shenzhen, Guangdong, China (enrolling)
• Novartis Investigative Site — Liuzhou, Guangxi, China (enrolling)
• Novartis Investigative Site — Wuhan, Hubei, China (enrolling)
• Novartis Investigative Site — Changchun, Jilin, China (enrolling)
• Novartis Investigative Site — Binzhou, Shandong, China (enrolling)
• Novartis Investigative Site — Beijing, China (enrolling)
• Novartis Investigative Site — Chongqing, China (enrolling)
• Novartis Investigative Site — Guangzhou, China (enrolling)
• Novartis Investigative Site — Guangzhou, China (enrolling)
• Novartis Investigative Site — Shanghai, China (enrolling)
• Novartis Investigative Site — Barranquilla, Atlántico, Colombia (enrolling)
• Novartis Investigative Site — Prague, Czechia (enrolling)
• Novartis Investigative Site — Guatemala City, Guatemala (enrolling)
• Novartis Investigative Site — Guatemala City, Guatemala (enrolling)
• Novartis Investigative Site — Tuenmen, Hong Kong (enrolling)
• Novartis Investigative Site — Budapest, Hungary (enrolling)
• Novartis Investigative Site — Kuala Lumpur, Kuala Lumpur, Malaysia (enrolling)

Full record on ClinicalTrials.gov

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