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Study of Elritercept for Treating Anemia in Adults with Low to Intermediate Risk Myelodysplastic Syndromes

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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 a condition known as myelodysplastic syndromes (MDS), which affects the blood and bone marrow, leading to anemia that requires regular blood transfusions. The study is testing a treatment called elritercept, also known by its code name KER-050. This treatment is given as a solution for injection and is being compared to a placebo to see if it can help reduce the need for blood transfusions in adults with very low, low, or intermediate-risk MDS.

The purpose of the study is to evaluate how effective elritercept is in reducing the number of red blood cell transfusions needed by participants. The study will involve participants receiving either the treatment or a placebo, and their progress will be monitored over a period of time. The main goal is to see if participants can achieve transfusion independence, meaning they do not need transfusions for at least eight weeks during the study period.

Participants will be closely monitored for any side effects or changes in their health, including laboratory tests, vital signs, and heart function tests. The study aims to provide valuable information on the safety and effectiveness of elritercept for treating transfusion-dependent anemia in people with myelodysplastic syndromes.

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

    Upon joining the study, you will be randomly assigned to receive either the study medication, elritercept, or a placebo. A placebo is a substance that looks like the medication but does not contain the active ingredient.

    The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are not influenced by expectations.

  2. Step 2

    Receiving the medication

    If you are assigned to receive elritercept, it will be administered as a solution for injection under the skin, known as subcutaneous use.

    The dosage, frequency, and duration of administration will be determined by the study protocol, and you will be informed of these details by the study team.

  3. Step 3

    Monitoring and assessments

    Throughout the study, you will undergo regular assessments to monitor your health and the effects of the treatment. This includes blood tests, vital signs checks, and possibly electrocardiograms (ECGs) to measure heart activity.

    The primary goal is to evaluate if elritercept can reduce the need for red blood cell transfusions in participants with myelodysplastic syndromes (MDS).

  4. Step 4

    Evaluating outcomes

    The study will assess whether you achieve transfusion independence for at least 8 weeks from the start of the study through week 24. Transfusion independence means you do not require red blood cell transfusions during this period.

    Secondary outcomes include achieving transfusion independence for 24 weeks and monitoring any side effects or adverse events that may occur during the study.

  5. Step 5

    Completion of the study

    The study is expected to continue until 2032, but your participation will be for a specific duration as outlined by the study team.

    Upon completion, you will receive information about the treatment you received and any relevant findings from the study.

Who can join the trial?

11 criteria

  • Must be a male or female who is at least 18 years old.
  • Must have a diagnosis of myelodysplastic syndromes (MDS), which is a group of disorders caused by poorly formed or dysfunctional blood cells. This diagnosis should be confirmed by a bone marrow test.
  • Must be dependent on blood transfusions, which means needing a certain number of red blood cell (RBC) transfusions in the 16 weeks before joining the study. This includes:
    • Receiving 4 to 7 RBC units in 16 weeks, or
    • Receiving 8 or more RBC units in 16 weeks.
    • Only transfusions for a hemoglobin level (a protein in red blood cells) of less than 10 g/dL are counted.
    • Must have had at least one transfusion in each 8-week period and at least two transfusions at least 7 days apart in the 16 weeks before joining the study.
    • Cannot have a period of 56 days in a row without needing an RBC transfusion in the 16 weeks before joining the study.
    • Must have tried and not responded to or cannot tolerate erythropoiesis-stimulating agents (ESA), which are treatments that help the body make more red blood cells, or are unlikely to respond to ESA treatment. This treatment should have been stopped at least 8 weeks before joining the study.
    • Must have less than 5% blasts in the bone marrow. Blasts are immature blood cells, and having too many can be a sign of disease.
    • Must have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well a person can perform daily activities.
    • Females who can have children and sexually active males must agree to use highly effective birth control methods.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer cannot participate.
  • Patients who have had a heart attack in the last 6 months are not eligible.
  • Patients with uncontrolled high blood pressure cannot join the study.
  • Patients with severe liver disease are excluded.
  • Patients with severe kidney disease cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible.
  • Patients who have received another investigational drug within the last 30 days cannot join.
  • Patients with a history of allergic reactions to similar drugs are excluded.
  • Patients with active infections that require treatment are not eligible.
  • Patients with a history of drug or alcohol abuse in the past year cannot participate.
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Investigated drugs

Elritercept (KER-050) is a medication being studied for its potential to help people with a condition called myelodysplastic syndromes (MDS), which can cause anemia, a shortage of red blood cells. This medication is being tested to see if it can reduce the need for blood transfusions in adults who have MDS and are dependent on transfusions to manage their anemia. The goal is to see if Elritercept can help the body produce more red blood cells on its own, reducing the need for transfusions and improving the patient's quality of life.

What is already known about the treatment

Elritercept (KER-050) – Elritercept is administered as an injection, typically given under the skin. It is currently being studied in clinical trials for its potential to treat anemia in adults with myelodysplastic syndromes (MDS), a group of disorders caused by poorly formed or dysfunctional blood cells. The main goal of this medication is to reduce the need for red blood cell transfusions in these patients. At the molecular level, Elritercept works by targeting specific pathways that regulate blood cell production, helping to increase the number of healthy red blood cells. It is classified as a therapeutic agent for blood disorders.

Investigated diseases

Myelodysplastic Syndromes – Myelodysplastic syndromes (MDS) are a group of disorders caused by poorly formed or dysfunctional blood cells. These syndromes occur when something goes wrong in the bone marrow, where blood cells are produced. Over time, the bone marrow becomes less effective at producing healthy blood cells, leading to a shortage of red blood cells, white blood cells, and platelets. This can result in symptoms such as fatigue, infections, and easy bruising or bleeding. As the disease progresses, the risk of developing acute myeloid leukemia (AML) may increase. MDS is considered a type of cancer and is often classified based on specific genetic changes and the number of immature blood cells present.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516009-22-00Protocol codeKER-050-D301Estimated enrolment233 patientsSponsorTakeda Development Center Americas Inc.

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