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Study on the Effects of Ianalumab with Standard Therapy for Patients with Active Lupus Nephritis

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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 medication is given as a solution for injection under the skin. The study will compare the effects of ianalumab with a placebo, which looks like the real treatment but does not contain the active substance.

The purpose of the study is to evaluate how well ianalumab works in combination with standard-of-care therapy, which is the usual treatment given for lupus nephritis. Participants in the study will receive either ianalumab or a placebo, along with their regular treatment. The study will last for a period of time, during which participants will have regular check-ups to monitor their health and the effects of the treatment.

Throughout the study, researchers will look at various outcomes, such as the stability of kidney function and any side effects that may occur. The goal is to see if ianalumab can help achieve a stable and complete response in kidney function by the end of the study period. Participants will be closely monitored to ensure their safety and to gather important information about the treatment's effectiveness and tolerability.

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

    Randomization and initial treatment

    Upon joining the study, participants are randomly assigned to receive either the medication ianalumab or a placebo. Both are administered as a subcutaneous injection using a pre-filled syringe.

    The initial treatment involves the use of high-dose corticosteroids and mycophenolic acid (MPA) as part of the standard-of-care therapy for lupus nephritis. This treatment should be started before or on the day of randomization.

  2. Step 2

    Treatment administration

    Participants receive the assigned treatment, either ianalumab or placebo, in combination with standard-of-care therapy. The treatment is administered regularly as per the study protocol.

    The goal is to achieve a stable complete renal response by Week 72, which involves maintaining kidney function and reducing protein levels in the urine.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes measuring the concentration of ianalumab in the blood and checking for any antibodies that may develop against the medication.

    Participants are also monitored for any adverse events or changes in vital signs and laboratory measurements.

  4. Step 4

    Evaluation of treatment response

    The primary goal is to evaluate the incidence of stable complete renal response at Week 72. Participants who discontinue treatment before this time or require higher doses of corticosteroids are considered non-responders.

    Secondary evaluations include measuring the time to achieve a significant reduction in protein levels in the urine and assessing overall response rates at Week 48.

  5. Step 5

    Completion of study

    The study is expected to conclude by July 2030. Participants will have completed all required assessments and treatments by this time.

    Final evaluations will determine the long-term effectiveness and safety of ianalumab in treating lupus nephritis.

Who can join the trial?

12 criteria

  • Adult male and female participants aged 18 years or older at the time of screening
  • Weigh at least 35 kg at screening
  • Have a confirmed clinical diagnosis of **SLE** (Systemic Lupus Erythematosus) according to specific classification criteria
  • Have a positive **anti-nuclear antibody (ANA)** test result, which is a blood test that helps detect certain autoimmune diseases, with a specific level at screening or a documented positive result in the past
  • Presence of active **LN** (Lupus Nephritis) at screening that requires starting treatment, shown by meeting these criteria:
    • A kidney biopsy within 6 months before screening showing specific types of kidney inflammation, or a biopsy done during the screening if not done before
    • A urine test showing a certain level of protein in the urine
    • A kidney function test showing a certain level of kidney function
    • Participants can be newly diagnosed or have been treated before, including those who did not respond to previous treatments, as long as they are on or willing to start standard treatment for LN using **MPA** (Mycophenolic Acid). This includes:
      • Starting treatment with high dose corticosteroids and MPA before or on the day of randomization
      • Stable dosing of anti-malarial treatment before randomization is recommended unless there are reasons not to use it
      • Participants on **azathioprine** treatment at screening must switch to MPA before randomization
      • Received at least one dose of a specific type of steroid treatment for the current episode of active LN within 60 days before randomization. If unable to take this treatment, they should start on a specific dose of oral steroids
      • Able to provide signed informed consent, which means they understand the study and agree to participate

Who cannot join the trial?

9 criteria

  • Patients who have a different kidney condition other than lupus nephritis cannot participate. Lupus nephritis is a kidney inflammation caused by lupus, an autoimmune disease.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a recent infection or illness that could affect the study results cannot participate.
  • Patients who have a history of drug or alcohol abuse that might interfere with the study cannot participate.
  • Patients who have received certain medications or treatments that could affect the study results cannot participate.
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Investigated drugs

Ianalumab is a medication being studied for its effectiveness, safety, and tolerability in treating active lupus nephritis. It is being tested to see if it can help achieve a stable complete renal response in patients when used alongside standard-of-care therapy.

What is already known about the treatment

Ianalumab – Ianalumab is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating lupus nephritis, a kidney condition associated with lupus. It is in the phase 3 stage of clinical trials, which means it is being tested for safety and efficacy in a larger group of participants. The main therapeutic indication for ianalumab is to achieve a stable complete renal response in patients with active lupus nephritis. At the molecular level, ianalumab works by targeting specific immune cells to reduce inflammation and prevent further kidney damage. It is classified as a monoclonal antibody, which is a type of medication designed to interact with specific 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 can cause the kidneys to become less effective at filtering waste from the blood, which may result in symptoms such as swelling, high blood pressure, and changes in urine. Over time, lupus nephritis can progress, leading to more severe kidney damage if not managed properly. The severity and progression of the disease can vary widely among individuals, with some experiencing mild symptoms and others facing more significant kidney impairment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508559-37-00Protocol codeCVAY736K12301Estimated enrolment372 patientsSponsorNovartis Pharma AG

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