Extension Study of Ianalumab for Lupus Nephritis
This is an extension study for people who have already participated in the SIRIUS-LN core study for lupus nephritis (a kidney disease caused by lupus). The study is testing ianalumab, a drug that targets certain immune cells (B cells) that contribute to lupus. The main goals are to see how well ianalumab works over a longer period and to monitor any side effects. Some participants who responded well to treatment in the core study will stop taking ianalumab to see if their improvements last, while others will continue with open-label ianalumab. To join, you must have completed the previous SIRIUS-LN core study. The study aims to enroll 348 participants. The current recruitment status is unclear.
- Study design
- This is an open-label extension study, meaning you and your doctors will know if you are receiving ianalumab. It plans to enroll 348 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 6 years, with some being monitored for up to 456 weeks (about 8.7 years) for kidney flare-ups or other events, and others for up to 560 weeks (about 10.7 years) for side effects.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)
At a glance
Conditions
Where it's being run
41 sites across 28 statesStudy leadership
- Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Cohort 1: Time to renal flare, increase in immunosuppressive medication, or deathBetween Week 144E1 and EOS (up to Week 456)
Cohort 1: To estimate the time to renal flare, increase in immunosuppressive medication, or death following study treatment withdrawal in participants who completed the SIRIUS-LN core study on double-blind treatment and achieved CRR or PRR at Week 140 of the core study
- Cohort 2: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)From the start of treatment in the SIRIUS-LN core study to EOS (up to week 560) of the extension study
Number of participants with AEs and SAEs, including changes in vital signs and clinical laboratory measurements qualifying and reported as AEs.