Ongoing Clinical Trials for Warm Autoimmune Haemolytic Anaemia
There are currently 3 ongoing clinical trials investigating new treatments for warm autoimmune haemolytic anaemia. These trials are taking place across several European countries and are testing different investigational medications aimed at helping patients whose previous treatments were not successful. The medications being studied work by targeting the immune system to reduce the destruction of red blood cells.
Clinical trial locations
- Austria
- France
- Germany
- Hungary
- Italy
- Norway
- Poland
- Romania
- Spain
Study of ianalumab versus placebo in adults with warm autoimmune hemolytic anemia who failed previous treatment
This trial is investigating ianalumab, also known as VAY736, as a potential treatment for adults whose condition has not improved after at least one previous treatment. The medication is designed to target the immune system to reduce the destruction of red blood cells that occurs in this disease.
Main inclusion criteria:
- Must be at least 18 years old
- Must have warm autoimmune haemolytic anaemia previously confirmed by a positive direct antiglobulin test
- Must have had insufficient response to, relapsed after, or shown intolerance to at least one previous treatment including corticosteroids
- Must have a hemoglobin level between 5 and 10 g/dL with symptoms of anemia
- Must be on stable supportive care treatment for at least 4 weeks before starting the study
Main exclusion criteria:
- History of severe allergic reactions to biological treatments
- Active or chronic hepatitis B or hepatitis C infection
- Current cancer diagnosis or cancer treatment within the past 5 years
- Severe or uncontrolled heart conditions
- Significant kidney or liver problems
- Active serious infections requiring treatment
- Pregnant or breastfeeding women
- Blood transfusion dependence
- Major surgery within 3 months before starting the study
Focus and goal: The main purpose of the study is to determine if ianalumab can help maintain healthy hemoglobin levels in people with this condition. Participants will be randomly assigned to receive either ianalumab or placebo through intravenous infusion. The treatment period lasts for 32 weeks, during which doctors will monitor blood levels, check for side effects, and track how participants feel. The study aims to see if the treatment can increase and maintain hemoglobin levels to 10 g/dL or higher, with at least a 2 g/dL increase from the starting level.
Investigational drug: Ianalumab works by targeting specific immune system components to reduce the production of harmful antibodies that cause red blood cell destruction. It belongs to the class of biological response modifiers and is administered through intravenous infusion. The study also uses a placebo for comparison purposes.
Study of Obexelimab for Patients with Warm Autoimmune Hemolytic Anemia
This trial is testing obexelimab, which is given as a weekly injection under the skin. The study is divided into three parts to evaluate both the safety and effectiveness of the treatment.
Main inclusion criteria:
- Must be at least 18 years old
- Must have been diagnosed with the condition for at least 3 months
- Must have a positive DAT test for specific antibodies related to the condition
- Must have tried at least one previous treatment, such as steroids or other specific medications
- Must have a hemoglobin level between 7 and less than 10 g/dL
- Must show at least one sign or symptom of anemia
- Must have adequate platelet and neutrophil counts
- If taking prednisone or prednisolone, the dose must not exceed 20 mg per day and be stable for at least 4 weeks
Main exclusion criteria:
- Any other serious health condition that might interfere with the study
- Pregnant or breastfeeding
- Recent infection requiring antibiotic treatment
- Recent use of another investigational drug
- History of drug or alcohol abuse
- Known allergy to the study medication or its ingredients
- History of certain types of cancer
- Conditions that affect the immune system
- Recent blood transfusion
Focus and goal: The study aims to evaluate the safety and effectiveness of obexelimab in treating patients. In the first part, the safety and appropriate dose will be confirmed. In the second part, the treatment will be compared to placebo to see if it helps improve anemia. In the third part, patients will continue receiving obexelimab to further assess its safety and benefits over a longer period. The trial will look at whether obexelimab can help increase hemoglobin levels and reduce the need for additional treatments like blood transfusions.
Investigational drug: Obexelimab is administered through a weekly subcutaneous injection under the skin. It works by targeting specific proteins involved in the immune response, helping to reduce the destruction of red blood cells. It is classified as an immunomodulatory agent, which means it helps to regulate or normalize the immune system’s activity.
Study on Povetacicept for Patients with Autoimmune Cytopenias (wAIHA, CAD, ITP)
This trial is studying povetacicept, also known as ALPN-303, for patients with autoimmune cytopenias, which include warm autoimmune haemolytic anaemia, cold agglutinin disease, and immune thrombocytopenia. The medication is given as an injection under the skin.
Main inclusion criteria for warm autoimmune haemolytic anaemia:
- Must have had the condition for at least 12 weeks, confirmed by a positive test for certain antibodies
- Must have a history of low hemoglobin with a level of 9 or less
- Must have at least one of the following: low haptoglobin or high lactate dehydrogenase
- Must have tried at least two treatments that did not work or the condition came back
- If taking standard medications, the doses must be stable for a certain period
Main exclusion criteria:
- Other serious health conditions that might interfere with the study
- Pregnant or breastfeeding
- Recent major surgery
- Currently participating in another clinical trial
- History of severe allergic reactions
- Active infection requiring treatment
- History of drug or alcohol abuse
- Recent use of certain medications that might affect study results
- History of cancer, except for certain types of skin cancer
- Uncontrolled high blood pressure or diabetes
Focus and goal: The purpose of the study is to evaluate the safety and tolerability of povetacicept in individuals with autoimmune conditions. This is an open-label trial, meaning both participants and researchers know which treatment is being administered. Throughout the study, participants will receive regular check-ups and assessments to monitor any side effects, measure the effectiveness of the medication, and conduct blood tests to monitor health indicators. The study aims to assess improvements in blood counts and other relevant health markers.
Investigational drug: Povetacicept is administered through an injection under the skin. It works by modulating the immune system to reduce the abnormal destruction of blood cells. It is classified as an immunomodulatory agent, aiming to balance the immune response in these specific blood disorders.
Summary
All three ongoing clinical trials are focused on patients whose condition has not responded adequately to previous treatments, highlighting the unmet need for new therapeutic options. The trials are concentrated in European countries, with Italy and Spain each hosting all three studies, while Germany also participates in two trials. France, Romania, Hungary, Austria, Norway, and Poland each host one trial.
Each trial is testing a different investigational medication, all of which work by modulating the immune system to reduce the destruction of red blood cells. Two of the medications, obexelimab and povetacicept, are administered as injections under the skin, while ianalumab is given through intravenous infusion. All three studies are designed to evaluate both the safety and effectiveness of these treatments in maintaining healthy hemoglobin levels and improving quality of life for patients. The trials require participants to have tried at least one or two previous treatments without success, and all have specific requirements regarding hemoglobin levels at study entry.
