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Study of ianalumab versus placebo in adults with warm autoimmune hemolytic anemia who failed 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 studies warm autoimmune hemolytic anemia (wAIHA), a condition where the body's immune system destroys its own red blood cells. The study tests a new medication called ianalumab (also known as VAY736) against placebo in people whose previous treatments were not successful. The medication is given through intravenous infusion.

The main purpose of the study is to determine if ianalumab can help maintain healthy blood levels in people with wAIHA. During the study, participants will be randomly assigned to receive either ianalumab or placebo. The study will measure whether the treatment can increase and maintain hemoglobin levels, which is an important component of red blood cells that carries oxygen throughout the body.

The treatment period lasts for 32 weeks, during which participants will receive regular infusions. Throughout the study, doctors will monitor blood levels, check for side effects, and track how participants feel. Some participants may also receive standard supportive care medications such as corticosteroids, antihistamines, or other treatments commonly used for this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Your participation begins with receiving either ianalumab or a placebo through intravenous infusion

    The treatment aims to increase your hemoglobin levels to 10 g/dL or higher, with at least a 2 g/dL increase from your starting level

    Your current hemoglobin level must be between 5 g/dL and 10 g/dL at the start of the study

  2. Step 2

    Treatment monitoring period (Weeks 1-8)

    Regular monitoring of your hemoglobin levels will occur

    Your blood will be tested to measure B-cell counts and immunoglobulin levels

    Medical staff will monitor your response to the treatment

  3. Step 3

    Response evaluation period (Weeks 9-25)

    The main evaluation period begins at week 9

    Your hemoglobin levels will be regularly checked to determine if you have achieved a lasting response

    A successful response means maintaining increased hemoglobin levels for at least 8 weeks

  4. Step 4

    Extended monitoring

    Blood tests will continue to check your response to treatment

    Medical staff will monitor any side effects

    Your overall health and well-being will be assessed through questionnaires

    The study continues until February 2029

Who can join the trial?

8 criteria

  • Must sign a written informed consent form before any screening tests can begin
  • Must be at least 18 years of age or older when signing the consent form
  • Must have warm autoimmune hemolytic anemia (wAIHA) that has been previously confirmed by a positive direct antiglobulin test (a blood test that checks for antibodies attached to red blood cells)
  • Must have had insufficient response to, or relapsed after, at least one previous treatment, including:
    • resistance to corticosteroids (medications that reduce inflammation)
    • dependence on corticosteroids
    • intolerance to corticosteroids
    • Must have a hemoglobin level (protein that carries oxygen in blood) between 5 and 10 g/dL and show symptoms of anemia during screening and first week
    • Must be on stable supportive care treatment for at least 4 weeks before being randomly assigned to a treatment group

Who cannot join the trial?

15 criteria

  • History of severe allergic reactions or anaphylaxis to biological treatments
  • Active or chronic hepatitis B or hepatitis C infection
  • Current diagnosis of malignancy (cancer) or cancer treatment within the past 5 years
  • Severe or uncontrolled cardiovascular disease (heart conditions)
  • Significant kidney or liver problems
  • Active serious infections requiring treatment
  • Pregnant or breastfeeding women
  • Use of prohibited medications within specified timeframe before study start
  • History of other autoimmune conditions that could interfere with the study
  • Mental conditions that could affect ability to comply with study procedures
  • Major surgery within 3 months before starting the study
  • Participation in another clinical trial within 30 days before this study
  • Blood transfusion dependence (requiring regular blood transfusions)
  • Presence of other blood disorders that could affect study results
  • Unstable medical conditions that could interfere with study participation
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Investigated drugs

  • Ianalumab (VAY736)

    is a medication being studied for the treatment of warm autoimmune hemolytic anemia (wAIHA). It is designed to help patients whose blood condition has not improved after at least one previous treatment. This medication works by targeting the immune system to reduce the destruction of red blood cells that occurs in this disease. The medication is being tested to see if it can help maintain healthy levels of hemoglobin in the blood.

  • Placebo

    is an inactive substance that contains no medication. It is used as a comparison to determine how effective the actual medication (ianalumab) is in treating the condition.

What is already known about the treatment

Ianalumab (VAY736) - A novel therapeutic antibody administered through injection that is currently being investigated in Phase 3 clinical trials for the treatment of warm autoimmune hemolytic anemia (wAIHA). This medication targets specific immune system components in patients whose own antibodies attack their red blood cells, particularly in cases where previous treatments have failed. Ianalumab belongs to the class of biological response modifiers and works by binding to and inhibiting B-cell activating factors, potentially reducing the production of harmful antibodies that cause red blood cell destruction. The drug represents a promising targeted therapy approach for patients with wAIHA who have not responded adequately to at least one previous line of treatment.

Investigated diseases

Warm Autoimmune Hemolytic Anemia (wAIHA) - A blood disorder where the immune system mistakenly attacks and destroys red blood cells at body temperature. In this condition, antibodies attach to red blood cells, causing them to break down faster than the body can replace them. The destruction of red blood cells leads to a decrease in hemoglobin levels and can cause anemia. The condition typically develops gradually and can occur at any age. Common signs include fatigue, weakness, pale skin, and shortness of breath due to reduced oxygen-carrying capacity of the blood.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510635-21-00Protocol codeCVAY736O12301Estimated enrolment92 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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