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A Phase 3 Study of Elritercept Versus Epoetin Alfa in ESA‑Naïve Adults with Lower‑Risk Myelodysplastic Syndrome Requiring Red Blood Cell Transfusions

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study focuses on adults who have Myelodysplastic syndromes and are experiencing anemia, a condition where the blood does not carry enough oxygen. Two medicines are being compared: the investigational drug elritercept and the approved medicine epoetin alfa. Both are given by injection under the skin to help the body produce more red blood cells.

The purpose of the study is to compare the effectiveness and safety of the two treatments in reducing the need for red blood cell transfusions. Participants are randomly assigned to receive either elritercept or epoetin alfa and will be treated for up to 24 weeks. During this time, they will have regular clinic visits where blood samples are taken to check hemoglobin levels, which indicate how well the blood is carrying oxygen, and doctors will record whether transfusions are still needed.

The study involves a series of visits scheduled roughly every few weeks. At each visit, a healthcare professional will administer the injection, perform a quick blood test, and ask about any side effects. The overall goal is to see if participants can stay without transfusions for a sustained period while their hemoglobin improves.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After joining the trial, a written informed consent form is signed, confirming understanding of the study procedures and potential risks.

  2. Step 2

    Baseline assessments

    Initial medical history, physical examination, and laboratory tests are performed.

    Baseline hemoglobin level is measured and the need for red blood cell transfusions is documented.

  3. Step 3

    Randomization

    The participant is assigned by the study system to receive either elritercept (test drug) or epoetin alfa (comparator).

  4. Step 4

    Start of treatment (cycle 1 day 1)

    On the first day of the treatment cycle, the assigned medication is administered by subcutaneous injection.

    elritercept is given at a dose of 5 mg per kilogram of body weight; the dose is expressed in milligram(s) per kilogram.

    epoetin alfa is given at a dose of 80 000 iu (international units); iu stands for international unit, a measure of biological activity.

  5. Step 5

    Regular drug administration

    The study drug continues to be given by subcutaneous injection according to the schedule defined in the trial protocol, typically on a weekly basis, for the duration of the 24‑week treatment period.

  6. Step 6

    Monitoring visits and laboratory tests

    The participant attends scheduled clinic visits where blood samples are drawn to measure hemoglobin level and assess safety parameters.

    Records of any red blood cell transfusions received are kept and reviewed at each visit.

  7. Step 7

    Assessment of red blood cell transfusion independence

    Throughout weeks 1 to 24, the study evaluates whether the participant achieves red blood cell transfusion independence, defined as at least twelve consecutive weeks without receiving a transfusion while the average hemoglobin increase from baseline is 1.5 g/dl or greater.

  8. Step 8

    Final evaluation at week 24

    At the end of the 24‑week period, a comprehensive assessment is performed, including the final hemoglobin measurement, review of transfusion history, and documentation of any adverse events.

  9. Step 9

    Study completion and follow‑up

    After the final evaluation, the participant completes the trial and may be offered a follow‑up visit to monitor long‑term safety, as outlined in the protocol.

Who can join the trial?

8 criteria

  • You must be 18 years old or older when you sign the informed consent form.
  • You must be able to understand why the study is being done and any possible risks, and you must voluntarily sign the informed consent form allowing the use of your health information.
  • You must have a documented diagnosis of myelodysplastic syndrome (MDS) that is classified as very low, low, or intermediate risk according to the International Prognostic Scoring System – Revised (IPSS‑R). This diagnosis must be confirmed by a central laboratory before randomization, and blood counts (hemoglobin, platelets, neutrophils) must be taken at least 14 days after any red blood cell transfusion or 7 days after any platelet transfusion.
  • Your bone marrow sample taken at screening must show less than 5% blasts (immature cells), and this must be confirmed by a central pathology reviewer.
  • Your natural blood level of erythropoietin (EPO) must be less than 500 units per liter, measured from a blood sample taken at least 14 days after any red blood cell transfusion.
  • You must need red blood cell transfusion, defined as receiving 2 to 6 units of packed red blood cells (pRBCs) within any 8‑week period for at least the 8 weeks immediately before randomization. At the time of each transfusion, your hemoglobin (Hgb) must have been 9.0 g/dL or lower (if you had symptoms of anemia) or 7.0 g/dL or lower (if you had no symptoms). Transfusions given for surgery, infections, or bleeding do not count toward this requirement.
  • Your most recent hemoglobin (Hgb) level after the last transfusion before randomization must be less than 11.0 g/dL.
  • Your overall health status must be rated as 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) performance scale, which measures how well you can perform daily activities.

Who cannot join the trial?

32 criteria

  • You have received any of the listed study drugs (such as epoetin alfa, darbepoetin, certain growth‑factor medicines, lenalidomide, hypomethylating agents, luspatercept, sotatercept, imetelstat, elritercept, immunosuppressive therapy, iron‑chelation drugs, androgens, high‑dose steroids, or any other investigational drug for MDS) within the time limits described; these medicines must not have been used recently unless a special exception was approved.
  • You have had a solid‑organ transplant (like a kidney or liver) or a bone‑marrow transplant in the past.
  • You currently have an infection that needed intravenous (through a vein) antibiotics in the past 28 days or oral antibiotics in the past 14 days.
  • You test positive for HIV, or you have an active hepatitis B or hepatitis C infection.
  • Your body‑mass index (BMI) is 40 kg/m² or higher (this indicates severe obesity).
  • You have had major surgery within the past 28 days.
  • You have had a new seizure or seizures that are not well controlled in the past 12 weeks.
  • You are allergic to the study drug or any of its ingredients, or you have had a severe allergic reaction (anaphylaxis) to similar medicines.
  • You have a history of pure red cell aplasia (a condition where the body stops making red blood cells) or antibodies that attack erythropoietin (a hormone that stimulates red blood cell production).
  • Your laboratory test results show any of the following:
    • Very low white‑blood‑cell count (ANC) below 500 cells per microliter.
    • Platelet count less than 50,000 or higher than 450,000 per microliter.
    • Liver enzymes (AST or ALT) three times higher than the normal upper limit.
    • Total bilirubin (a waste product from red blood cells) two times higher than normal.
    • Kidney function measured by eGFR less than 30 mL/min/1.73 m² (indicates severe kidney disease).
    • Ferritin (iron storage protein) 50 µg/L or lower.
    • Folate (vitamin B9) 2.0 ng/mL or lower.
    • Vitamin B12 200 pg/mL or lower.
    • You are currently taking part in another interventional clinical trial or have used another investigational medicine within a period equal to five times that drug’s half‑life.
    • You have a type of MDS that is classified as del(5q) cytogenetic abnormality, unclassifiable MDS, or secondary MDS according to the WHO 2016 guidelines.
    • You are unwilling or, in the investigator’s judgment, unable to follow the study’s rules and visits.
    • You are of childbearing potential and will not use at least one highly effective form of contraception from the start of the study until at least 60 days after the last dose.
    • If you are a male participant with a partner who could become pregnant, you will not use a barrier method (such as a condom) throughout the study and for at least 60 days after the last dose.
    • You are pregnant, have a positive pregnancy test during screening, or are breastfeeding and do not agree to stop breastfeeding for the required time.
    • In France, you are under court protection, not covered by social security, or otherwise legally protected as an adult under French law.
    • You have a known diagnosis of acute myeloid leukemia (AML).
    • Your anemia is caused by another known problem such as thalassemia, thyroid disease, iron, vitamin B12, vitamin B6, zinc or folate deficiency, autoimmune or hereditary hemolytic anemia, significant bleeding, or drug‑induced anemia.
    • You have serious heart disease, defined as any of the following:
      • New York Heart Association (NYHA) class III or IV heart failure (moderate to severe limitation of physical activity).
      • QTc interval (a measure of heart rhythm on an ECG) longer than 500 milliseconds.
      • Uncontrolled irregular heartbeat, recent heart attack, or unstable chest pain within the past 6 months.
      • Your heart’s ejection fraction (the percentage of blood the heart pumps out with each beat) is less than 35 %.
      • You have had a blood‑clot‑related event (stroke, transient ischemic attack, deep‑vein thrombosis, pulmonary embolism, arterial clot, etc.) within the past 6 months (superficial vein inflammation is allowed).
      • You have a history of other cancers (besides MDS) unless you have been cancer‑free for at least 3 years after completing all treatment; certain skin cancers, in‑situ cervical or breast cancers, and early‑stage prostate cancer are permitted if not requiring systemic therapy.
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Investigated drugs

  • Erythropoietin (epoetin alfa)

    is a medication that helps the bone marrow make more red blood cells. In this study it is used as the standard treatment (comparator) to see how well the new drug works. Participants receive it by injection under the skin. The goal is to reduce the need for blood transfusions by raising the level of hemoglobin in the blood.

  • Elritercept

    is an experimental drug being tested for the first time in this trial. It is given as a solution for injection under the skin. The study is looking at whether Elritercept can help patients with certain low‑risk blood disorders become independent from red blood cell transfusions for at least 12 weeks, while also increasing their hemoglobin by at least 1.5 g/dL. It is being compared directly to epoetin alfa to evaluate its effectiveness and safety.

What is already known about the treatment

  • Erythropoietin

    Erythropoietin is given by a subcutaneous injection in a liquid form and is an approved, widely used medicine for treating anemia, especially in conditions like myelodysplastic syndromes. It works like a natural hormone that tells the bone marrow to make more red blood cells, raising hemoglobin levels. The drug belongs to the class of recombinant human erythropoietins, which are synthetic versions of the body’s own red‑cell‑stimulating protein. Its safety and effectiveness are well recorded in medical literature.

  • Elritercept

    Elritercept is administered as a subcutaneous injection of a liquid solution, and it is currently being studied in a phase 3 trial and is not yet approved for general medical use. The drug is intended for patients with anemia caused by myelodysplastic syndromes who need blood transfusions. It works by attaching to and blocking specific signals that prevent the bone marrow from making red blood cells, thereby encouraging the body to produce more of them. Elritercept belongs to a class of experimental biologic agents that act as cytokine‑blocking fusion proteins.

Investigated diseases

Myelodysplastic syndromes (MDS) - Myelodysplastic syndromes are a group of disorders where the bone marrow makes too few and abnormally formed blood cells. The condition often starts with a slow decline in red blood cells, causing fatigue and weakness. Over months, white blood cells and platelets may also decrease, leading to more frequent infections or easy bruising. The marrow cells appear irregular and do not mature properly. The disease may remain relatively stable for some time or gradually become more severe as blood cell production worsens.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523544-12-00Protocol codeTAK-226-3001Estimated enrolment304 patientsSponsorTakeda Development Center Americas Inc.

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