Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study of ianalumab for adults with primary immune thrombocytopenia or warm-antibody autoimmune hemolytic anemia who previously responded to ianalumab

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study involves two blood disorders. Immune thrombocytopenia is a condition where the immune system mistakenly destroys platelets, which are blood cells that help stop bleeding, leading to low platelet counts and increased risk of bruising and bleeding. Warm-antibody autoimmune hemolytic anemia is a condition where the immune system destroys red blood cells, which carry oxygen throughout the body, causing anemia with symptoms like fatigue and weakness. The study will use a medication called ianalumab, also known as VAY736, which is given through a vein. This medication is designed to affect certain immune system cells that contribute to these blood disorders. Participants may also receive other medications during the study including pain relievers, entecavir which is an antiviral medication, medications that help blood clotting, antihistamines for allergic reactions, danazol which affects hormone production and immune function, and glucocorticoids which are steroid medications that reduce inflammation.

The purpose of this study is to see if a second course of treatment with ianalumab can help people who previously received this medication and experienced improvement but then had their condition return. For people with immune thrombocytopenia, the study will look at whether the second treatment can maintain platelet counts and reduce the need for additional treatments. For people with warm-antibody autoimmune hemolytic anemia, the study will check if the second treatment can maintain hemoglobin levels, which reflects the amount of red blood cells in the blood, and reduce symptoms of anemia.

Participants in this study must have previously taken part in earlier research studies with ianalumab and must have experienced benefit from the treatment but later had their condition worsen. The study will involve receiving ianalumab infusions and regular monitoring visits where blood samples will be taken to measure blood cell counts and check for any side effects. The treatment period will last up to 16 weeks, and participants will be followed for several months afterward to assess how long the benefits last and to monitor safety. During the study, some participants may receive additional supportive treatments or rescue medications if needed to manage their symptoms.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Screening and enrollment

    Your doctor will review your medical history and confirm that you previously participated in a study with ianalumab and had a positive response to the treatment.

    If you have immune thrombocytopenia, a condition where your body does not have enough platelets to help blood clot properly, your platelet count must be checked. The count should be below 30,000 per microliter of blood.

    If you have warm-antibody autoimmune hemolytic anemia, a condition where your immune system destroys your red blood cells, your hemoglobin level must be checked. Hemoglobin is a protein in red blood cells that carries oxygen. Your level should be at least 5 grams per deciliter but less than 10 grams per deciliter, and you should have symptoms related to anemia.

    Your doctor may have started you on rescue medication or bridging therapy within 28 days before screening. These are temporary treatments used to manage your condition.

    If you were already taking supportive care treatment in the previous study when your condition returned, you should continue this treatment at the same dose for at least 4 weeks before screening.

  2. Step 2

    Treatment period with ianalumab

    You will receive a second course of treatment with ianalumab, which is given through a vein in your arm. This is called an intravenous infusion.

    The study will monitor how well this second course of treatment works for your condition.

    The specific dosing schedule and number of infusions will be determined by the study protocol.

  3. Step 3

    Monitoring during treatment for immune thrombocytopenia

    If you have immune thrombocytopenia, your doctor will monitor your platelet count regularly throughout the study.

    The goal is to keep your platelet count above 30,000 per microliter of blood after 8 weeks from the start of treatment.

    Your doctor will check whether you need any rescue treatments after the first 8 weeks of treatment.

    If you are taking a medication called thrombopoietin receptor agonist, which helps your body make more platelets, your doctor will try to reduce the dose by week 24.

  4. Step 4

    Monitoring during treatment for warm-antibody autoimmune hemolytic anemia

    If you have warm-antibody autoimmune hemolytic anemia, your doctor will monitor your hemoglobin levels regularly throughout the study.

    The goal is to achieve a hemoglobin level of at least 10 grams per deciliter, with an increase of at least 2 grams per deciliter from your starting level.

    This improvement should last for at least 8 consecutive weeks between week 9 and week 25 of treatment.

    Your doctor will monitor whether you need any rescue treatments or new medications for your condition.

  5. Step 5

    Safety monitoring throughout the study

    Your doctor will monitor you for any side effects or adverse events throughout the study.

    Special attention will be given to monitoring for severe infections.

    Blood samples will be taken to measure the level of ianalumab in your blood.

    Blood samples will also be taken to check if your body develops antibodies against ianalumab. Antibodies are proteins your immune system makes in response to substances it recognizes.

  6. Step 6

    Follow-up period

    The study will continue to monitor your condition for up to 12 months after you start the second course of ianalumab.

    Your doctor will assess whether the treatment has been successful in managing your condition without the need for additional rescue treatments or new medications.

    Regular check-ups will be scheduled to evaluate your response to treatment and overall health.

Who can join the trial?

8 criteria

  • You must sign a document showing you agree to join the study before any study activities begin
  • You must be 18 years old or older when you sign the agreement form
  • If you have primary ITP (a condition where your immune system destroys blood cells called platelets, which help your blood clot): You must have been in a previous study where you received the study medicine called ianalumab or a placebo (a substance with no active medicine) along with other treatments, and your condition came back at least 2 years after your last treatment dose in that study
  • You may use emergency medicines or temporary treatments to help manage your condition within 28 days before joining this study. However, your platelet count (number of platelets in your blood) must be measured before starting these medicines and within 30 days before joining
  • If you have wAIHA (a condition where your immune system destroys your red blood cells, causing anemia, which means low levels of a protein called hemoglobin that carries oxygen in your blood): You must have had a positive test called DAT that confirms your condition, been in a previous study with ianalumab or placebo, and had a good response that lasted more than 2 years after your last dose
  • If you have wAIHA: Your condition must have come back with hemoglobin levels between 5 and 10 grams per deciliter, and you must have symptoms of anemia (such as tiredness or weakness) during the screening period or within 14 days before, or within 28 days before if you started emergency medicines
  • You may use emergency medicines or temporary treatments during the screening period or within 28 days before joining. Your hemoglobin level must be measured before starting these treatments and within 30 days before joining
  • If you were taking supportive care medicines in the previous study when your condition came back, you may continue them, but they must have stayed at the same dose for at least 4 weeks before joining this study

Who cannot join the trial?

4 criteria

  • The source data does not contain specific exclusion criteria for this clinical trial
  • This study is for people with immune thrombocytopenia (a condition where the body attacks its own blood cells that help with clotting) or warm autoimmune hemolytic anemia (a condition where the body destroys its own red blood cells)
  • The trial is designed for patients who previously received treatment with ianalumab, had improvement, but then had their condition return
  • Without detailed exclusion criteria listed in the source data, specific reasons why someone cannot participate are not available
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Ianalumab is an investigational medication being studied for adults with two blood disorders: primary immune thrombocytopenia (ITP), which is a condition where the body destroys its own blood platelets, and warm-antibody autoimmune hemolytic anemia (wAIHA), which is a condition where the body destroys its own red blood cells. This medication works by targeting specific cells in the immune system that may be causing these blood disorders. In this study, ianalumab is being given to patients who previously received this medication and had improvement in their condition, but later experienced a return of their symptoms.

What is already known about the treatment

Ianalumab – Ianalumab is an experimental medication currently being studied in clinical trials for the treatment of immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA), which are conditions where the body's immune system mistakenly attacks its own blood cells. This drug works at the molecular level by targeting and blocking a specific protein called BAFF receptor on certain immune cells called B cells, which helps reduce the production of harmful antibodies that destroy blood cells. The medication is administered through injection and belongs to a class of drugs known as monoclonal antibodies, which are designed to precisely target specific parts of the immune system. This study is exploring whether patients who previously responded well to ianalumab but experienced a return of symptoms can benefit from receiving the treatment again.

Investigated diseases

  • Immune Thrombocytopenia

    Immune thrombocytopenia is a blood disorder in which the immune system mistakenly destroys platelets, which are cell fragments necessary for normal blood clotting. People with this condition have an unusually low number of platelets in their blood. The disease can develop suddenly or gradually over time. When platelet counts drop significantly, affected individuals may experience easy bruising, bleeding gums, or small red spots on the skin. The condition may occur without any known cause or may develop following infections or other triggering events. Some people experience periods when the platelet count improves, followed by times when it drops again.

  • Warm Autoimmune Hemolytic Anemia

    Warm autoimmune hemolytic anemia is a condition in which the immune system produces antibodies that attack and destroy red blood cells at body temperature. The destruction of red blood cells occurs faster than the body can replace them, leading to anemia. People with this condition may feel tired, weak, and short of breath due to the reduced number of red blood cells. The skin and eyes may appear pale or yellowish as red blood cells break down. The spleen, which filters damaged blood cells, may become enlarged as it works to remove the damaged cells. Symptoms can develop gradually or appear suddenly, and the severity can vary from mild to more serious forms.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518231-11-00Protocol codeCVAY736Q12202BEstimated enrolment99 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.