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Study on Long-Term Safety of Ianalumab for Patients with Systemic Lupus Erythematosus

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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 long-term safety and tolerability of a treatment called ianalumab in patients with Systemic Lupus Erythematosus (SLE). SLE is a chronic autoimmune disease where the body's immune system mistakenly attacks healthy tissue, causing inflammation and damage to various parts of the body. The study involves administering ianalumab, which is given as a solution for injection under the skin, either monthly or quarterly. The purpose of the study is to evaluate how safe and well-tolerated ianalumab is over an extended period.

Participants in the study may receive ianalumab or a placebo. The study will monitor participants for any side effects or adverse reactions that may occur during the treatment period. The study will also assess the overall health and condition of the participants over time, including any changes in their disease symptoms and the use of other medications, such as oral corticosteroids, which are often used to reduce inflammation in SLE.

The study is designed to last for several years, allowing researchers to gather comprehensive data on the long-term effects of ianalumab in treating SLE. Participants will be regularly evaluated to track their progress and any changes in their condition. This research aims to provide valuable insights into the potential benefits and risks of using ianalumab as a treatment option for individuals living with Systemic Lupus Erythematosus.

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

    Participation begins after signing an informed consent form. If under 18, a parent or guardian must also sign, and the participant must give assent. If the participant reaches the age of consent during the study, they must sign the consent form at the next visit.

  2. Step 2

    Eligibility confirmation

    Eligibility requires prior participation in one of the SIRIUS-SLE core studies and completion of the treatment period through Week 60 without discontinuation. The investigator must determine that continued treatment is expected to be beneficial.

  3. Step 3

    Treatment administration

    The study involves the administration of ianalumab at a dose of 300 mg. This is given as a subcutaneous injection, either monthly or quarterly, depending on the assigned regimen.

  4. Step 4

    Monitoring and assessments

    Participants will be monitored for any treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs).

    The study will assess the proportion of participants achieving a specific response (SRI-4) and changes in a damage index (SLICC/ACR) up to Week 216.

    The average daily dose of oral corticosteroids and the rate of moderate or severe disease flares will also be evaluated annually up to Week 216.

  5. Step 5

    Study duration

    The study is expected to continue until December 23, 2031. Recruitment is estimated to start on May 21, 2024.

Who can join the trial?

4 criteria

  • You must sign a document called an informed consent before joining the study. If you are under 18, your parent or legal guardian must sign it, and you must agree to participate. If you become old enough to give consent during the study, you will need to sign the form yourself at your next visit.
  • You must have been part of one of the two previous studies called SIRIUS-SLE, specifically studies CVAY736F12301 or CVAY736F12302, and completed the treatment period up to Week 60 without stopping the treatment.
  • The study doctor must believe that you will benefit from continuing the study treatment.
  • Both males and females can participate in the study.
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Investigated drugs

Ianalumab is a medication being studied for its long-term safety and tolerability in patients with systemic lupus erythematosus (SLE). It is administered as an injection under the skin, either once a month or once every three months. The study aims to understand how well patients tolerate this medication over an extended period.

What is already known about the treatment

Ianalumab – Ianalumab is administered as a subcutaneous injection, either monthly or quarterly, for patients with active systemic lupus erythematosus (SLE). It is currently being studied in clinical trials to assess its long-term safety and tolerability. The main therapeutic indication for ianalumab is the treatment of systemic lupus erythematosus, an autoimmune disease. At the molecular level, ianalumab works by targeting and modulating specific immune cells to reduce inflammation and disease activity. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

Systemic Lupus Erythematosus – Systemic Lupus Erythematosus (SLE) is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. The disease often presents with symptoms such as fatigue, joint pain, skin rashes, and fever. SLE is characterized by periods of illness, called flares, and periods of wellness, or remission. The severity and progression of the disease can vary widely among individuals. Over time, SLE can lead to damage in the affected organs and tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505929-14-00Protocol codeVAY736F12301E1Estimated enrolment530 patientsSponsorNovartis Pharma AG

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