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Study on the Effects and Safety of Ianalumab in Adults with Lupus Nephritis Who Completed Previous Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for lupus nephritis, a condition where the immune system attacks the kidneys, causing inflammation and damage. The treatment being tested is called ianalumab, also known by its code name VAY736. This study is an extension of a previous study, and it aims to evaluate the safety and effectiveness of continuing or stopping the treatment in participants who have already completed the initial study.

Participants in this study will receive ianalumab through a solution for injection. The study will observe the participants over a period to see if there are any changes in their condition, such as a return of kidney problems or the need to increase other medications that suppress the immune system. The study will also monitor for any side effects or health changes that may occur during the treatment period.

In addition to ianalumab, the study involves other medications that participants may have been taking, such as mycophenolate mofetil, tenofovir alafenamide, emtricitabine, tenofovir disoproxil, and entecavir. These medications are typically used to manage immune system activity and viral infections. The study will help determine the best approach to managing lupus nephritis in the long term, either by continuing the treatment or by safely withdrawing it.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, ensure that you have signed the informed consent form. This confirms your understanding and agreement to participate in the study.

    Participation requires completion of the previous SIRIUS-LN core study up to Week 144.

  2. Step 2

    Treatment phase

    During the treatment phase, you may receive ianalumab through a subcutaneous route, which means it is administered under the skin.

    The study will assess the safety and tolerability of ianalumab for those who were already receiving it or did not meet certain criteria in the previous study.

  3. Step 3

    Monitoring and assessments

    Regular monitoring will occur to check for any renal flare or the need for increased medication. This will be observed from Week 144E1 to Week 248.

    You will undergo assessments for any treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) throughout the study.

  4. Step 4

    Antibody and concentration checks

    The study will measure the presence and levels of anti-ianalumab antibodies in your blood from Week 144E1 to Week 248.

    The concentration of ianalumab in your blood will also be monitored to understand how your body processes the medication.

  5. Step 5

    Completion of the study

    The study is expected to continue until August 9, 2032. Your participation will contribute to understanding the long-term effects and safety of the treatment.

    Upon completion, all data collected will be analyzed to assess the overall outcomes of the study.

Who can join the trial?

4 criteria

  • Must have signed an informed consent form before joining the extension study. This means you agree to participate after being told about the study's details.
  • Must have taken part in the SIRIUS-LN core study and completed all treatments up to Week 144, whether on a double-blind or open-label treatment. Double-blind means neither you nor the researchers know if you are receiving the actual treatment or a placebo. Open-label means both you and the researchers know you are receiving the actual treatment.
  • Open to both males and females.
  • Participants can be from vulnerable populations, which means groups that might need special protection or care.

Who cannot join the trial?

4 criteria

  • Participants who have not completed the SIRIUS-LN core study.
  • Participants who did not achieve CRR or PRR at Week 140 of the core study.
    • CRR means Complete Renal Response, which is when the kidneys are working well again.
    • PRR means Partial Renal Response, which is when the kidneys are working better but not completely normal.
    • Participants who are not receiving or did not meet criteria for ianalumab treatment at the end of the SIRIUS-LN core study.
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Investigated drugs

Ianalumab is a medication being studied for its potential to help people with lupus nephritis, a condition where the immune system attacks the kidneys. In this trial, researchers are looking at how well ianalumab works and how safe it is for patients who have already participated in a previous study. The goal is to see if ianalumab can help maintain kidney health and prevent flare-ups of the disease. This medication is being tested to understand if it can be a long-term treatment option for people with this condition.

What is already known about the treatment

Ianalumab – Ianalumab is administered as an injection, typically given under the skin. It is currently being studied in clinical trials for its effectiveness and safety in treating lupus nephritis, a kidney condition associated with lupus. The main therapeutic use of ianalumab is to help manage lupus nephritis by potentially reducing kidney inflammation and preventing kidney damage. At the molecular level, ianalumab works by targeting specific proteins in the immune system to reduce inflammation and immune response. It is classified as a monoclonal antibody, which is a type of medication designed to target specific cells or proteins in the body.

Investigated diseases

Lupus nephritis – Lupus nephritis is a kidney disorder that is a complication of systemic lupus erythematosus (SLE), an autoimmune disease. In this condition, the immune system mistakenly attacks the kidneys, leading to inflammation and potential damage. The disease progresses as the inflammation causes the kidneys to become less effective at filtering waste from the blood. Over time, this can lead to proteinuria, where protein leaks into the urine, and hematuria, where blood is present in the urine. As the condition advances, it may result in swelling, high blood pressure, and impaired kidney function. The severity and progression can vary widely among individuals, with some experiencing mild symptoms and others facing more significant kidney impairment.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515280-60-00Protocol codeCVAY736K12301E1Estimated enrolment344 patientsSponsorNovartis Pharma AG

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