A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions

Recruiting now · Phase 3

Conditions studied: Myelodysplastic Syndrome, Anemia

In brief

The main aim of this study is to assess how elritercept works in lowering the need for RBC (red blood cell) transfusions and how safe elritercept is when compared with epoetin alfa. Other aims are to learn if elritercept improves tiredness as reported by participants without needing RBC transfusion compared with epoetin alfa, the RBC transfusion burden and quality of life compared with epoetin alfa. The study also aims to find out the extent of the immune response to elritercept. The study will also check on the medical problems (safety) of elritercept.

Key facts

Study ID

NCT07422480

Run by

Takeda

People needed

300

Starts

2026-05-21

Expected to finish

2033-10-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants aged ≥ 18 years or older at time of signing the informed consent form (ICF).
• Able to understand the purpose and risks of the trial and voluntarily sign an ICF prior to any trial-related procedures being conducted and authorization to use protected health information and personal data in accordance to national and local privacy regulations.
• Documented diagnosis of myelodysplastic syndrome(s) (MDS) according to WHO 2016 classification that meets International Prognostic Scoring System - Revised (IPSS-R) classification of very low-, low-, or intermediate-risk disease, confirmed by central laboratory independent reviewer prior to randomization. Hemoglobin (Hgb), platelet, and absolute neutrophil count (ANC) values should be collected greater than (>) 14 days after red blood cell (RBC) transfusion or greater than (>) 7 days after platelet transfusion, unless otherwise considered to be pretransfusion values.
• Bone marrow less than (<) 5% blasts in an evaluable bone marrow collected at screening and confirmed by central pathology independent reviewer.
• Endogenous serum erythropoietin s (EPO) level of <500 U/L. Should be results from blood samples collected >14 days following an RBC transfusion to evaluate for eligibility unless considered pretransfusion values.
• Participant requires RBC transfusion, as documented by the following criteria. A transfusion requirement of 2 to 6 pRBCs units/8 weeks confirmed for a minimum of 8 weeks immediately preceding randomization.
• Hgb levels at the time of or within 3 days prior to administration of a RBC transfusion must have been less than or equal to (≤) 9.0 grams per deciliter (g/dL) (5.6 millimoles per liter (mmol/L)) with symptoms of anemia (or ≤7 g/dL [4.3 mmol/L] in the absence of symptoms) in order for the transfusion to be counted towards meeting eligibility criteria.
• RBC transfusions administered when hemoglobin (Hgb) levels were >9.0 g/dL (or >7 g/dL in the absence of symptoms) and/or RBC transfusions administered for elective surgery, infections or bleeding events will not qualify as a required transfusion for the purpose of meeting eligibility criteria or stratification.
• Hgb <11.0 g/dL (6.8 mmol/L) after last RBC transfusion preceding randomization. Local laboratory is acceptable to facilitate randomization.
• Eastern Cooperative Oncology Group score of 0, 1, or 2. Exclusion Criteria
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• Prior therapy with any of the following:
• Epoetin alfa
• At the investigator's discretion in consultation with the medical monitor, may be allowed if received no more than 2 doses of only epoetin alfa ≥8 weeks prior to randomization. No other erythropoiesis-stimulating agent (ESA) agent is allowed.
• Darbepoetin
• Granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor administered ≤8 weeks (56 days) prior to randomization unless given for treatment of febrile neutropenia.
• Immunomodulatory drug (IMiDs) including lenalidomide
• At the investigator's discretion in consultation with the medical monitor may be allowed if received ≤1 week of an IMiD ≥8 weeks prior to randomization.
• Hypomethylating agent
• At the investigator's discretion, in consultation with the medical monitor may be allowed if received no more than 2 doses ≥8 weeks prior to randomization.
• Luspatercept, sotatercept, imetelstat, or elritercept
• Immunosuppressive therapy
• Hematopoeitic cell transplant
• Iron chelation if administered ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed Vitamin B12 or folate therapy initiated within 4 weeks prior to randomization. Participants on stable replacement doses for ≥4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.
• Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed

Where it is running

• Institute of Cancer Research and Treatment of Candiolo — Candiolo, Torino, Italy (enrolling)
• NTT Medical Center Tokyo — Shinagawa-ku, Tokyo, Japan (enrolling)
• Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology — Sofia, Bulgaria (enrolling)
• Szent Borbala Korhaz, Department of Internal Medicine and Haematology, Division of Hematology — Tatabánya, Komárom-Esztergom, Hungary (enrolling)
• Chugoku Central Hospital — Fukuyama-shi, Hiroshima, Japan (enrolling)
• Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital — Bunkyo-ku, Tokyo, Japan (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD) — Plovdiv, Bulgaria (enrolling)
• Praxis am Volkspark — Berlin, Germany (enrolling)
• University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology — Debrecen, H-B, Hungary (enrolling)
• Fukushima Medical University Hospital — Fukushima, Fukushima, Japan, Japan (enrolling)
• Gifu Municipal Hospital — Gifu, Gifu, Japan (enrolling)
• Hyogo Prefectural Amagasaki General Medical Center — Amagasaki-shi, Hyōgo, Japan (enrolling)
• Dokkyo Medical University Hospital — Mibu, Tochigi, Japan (enrolling)
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States (enrolling)
• World Research Link — Baytown, Texas, United States (enrolling)
• Orchard Healthcare Research Inc. (OHR) - Skokie — Skokie, Illinois, United States (enrolling)
• The Center for Cancer and Blood Disorders — Fort Worth, Texas, United States (enrolling)
• Gemeinschaftspraxis fuer Haematologie und Onkologie - Praxis Steinfurter Strasse — Münster, North Rhine-Westphalia, Germany (enrolling)
• LUMI Research — Houston, Texas, United States (enrolling)
• American Oncology Partners P.A. MidAmerica Cancer Care — Kansas City, Missouri, United States (enrolling)
• Charite Campus Benjamin Franklin — Berlin, Germany (enrolling)
• BRCR Medical Center Inc — Tamarac, Florida, United States (enrolling)
• NHO Nagoya Medical Center — Nagoya, Aichi-ken, Japan (enrolling)
• Amsterdam UMC-Locatie VUMC (Vrije Universiteit Medisch Centrum) — Amsterdam, North Holland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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