The purpose of this 2-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.
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
For cohort 1: Incidence of renal flare, escalation of immunosuppressive medication, or death
Timeframe: Between Week 144E1 and Week 248
Cohort 2: Number of participants with Treatment Emergent Adverse Events (TEAE) as assessed by CTAE v4.0
Timeframe: From the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study
Cohort 2: Number of participants with Serious Adverse Events (SAE) as assessed by CTCAE v4.0
Timeframe: From the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study
Cohort 2: Number of participants with clinically significant abnormal vital signs
Timeframe: From the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study
Cohort 2: Number of participants with clinically significant laboratory evaluations.
Timeframe: From the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study