RECRUITING Phase 3 ClinicalTrials.gov

A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Lower Risk Myelodysplastic Syndromes (LR-MDS) Who Need Regular Blood Transfusions

Sponsor: Takeda • ClinicalTrials.gov ID: NCT07422480

Registry updated: 2026-10-19

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

The main aim of this study is to assess how much elritercept reduces the need for RBC (red blood cell) transfusions and improves hemoglobin blood values in addition to how safe elritercept is when compared with epoetin alfa. Other key aims are to learn how much elritercept improves tiredness and quality of life as reported by participants compared with epoetin alfa; to assess what risks (side effects) and how often they occur with elritercept compared with epoetin alfa. The study will also collect information for researchers to see how the disease in the bone marrow or other body areas may be affected by elritercept compared with epoetin alfa to try to learn how to better treat this disease.

Interventions

Elritercept (Drug)
Elritercept, SC injection.
Epoetin Alfa (Drug)
Epoetin Alfa, SC injection.

Eligibility criteria

Inclusion Criteria 1. Male or female participants aged ≥ 18 years or older at time of signing the informed consent form (ICF). 2. 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. 3. 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 \> 7 days after platelet transfusion, unless otherwise considered to be pretransfusion values. 4. Bone marrow less than (\<) 5% blasts in an evaluable bone marrow collected at screening and confirmed by central pathology independent reviewer. 5. Endogenous serum erythropoietin (EPO) level of \<500 units per liter (U/L). Should be results from blood samples collected \>14 days following an RBC transfusion to evaluate for eligibility unless considered pretransfusion values. 6. 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. 7. Hgb \<11.0 g/dL (6.8 mmol/L) before randomization. Local laboratory is acceptable to facilitate randomization. 8. Eastern Cooperative Oncology Group score of 0, 1, or 2. Exclusion Criteria 1. Prior therapy with any of the following: 1. 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. 2. Darbepoetin • At the investigator's discretion in consultation with the medical monitor, may be allowed if received no more than 1 dose of only darbepoetin ≥8 weeks prior to randomization. 3. 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. 4. 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. 5. 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. 6. Luspatercept, sotatercept, imetelstat, or elritercept 7. Immunosuppressive therapy for the disease under study. 8. Hematopoeitic cell transplant 9. Iron chelation if initiated ≤8 weeks prior to randomization. Participants on stable or decreasing doses of iron chelation therapy for ≥8 weeks are allowed. 10. Vitamin B12 or folate therapy initiated within 4 weeks prior to randomization. Participants on stable or decreasing replacement doses for ≥4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed. 11. Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed 12. High-dose systemic corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone ≤10 millligrams per day (mg/day) or corticosteroid equivalent for ≥4 weeks are allowed. Other disease modifying treatments for autoimmune diseases may be allowed upon medical monitor review. 13. Investigational agent or any other agent intended for MDS treatment 2. Diagnosed to have MDS with presence of del(5q) cytogenetic abnormality or MDS unclassifiable according to WHO 2016 classification or secondary MDS. 3. Known history of diagnosis of acute myeloid leukemia (AML). 4. Anemia due to any other known cause including but not limited to thalassemia; hypothyroidism, autoimmune or hereditary hemolytic anemia, any type of known clinically significant bleeding or sequestration or drug induced anemia, hemolytic anemia, bleeding events, or other deficiencies (that is, iron, folate, or vitamin B12). 5. Clinically significant cardiovascular disease defined as: 1. New York Heart Association heart disease class III or IV 2. Fridericia corrected QT (QTcF) interval \>500 milliseconds during screening 3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening 6. Known ejection fraction \<35%, confirmed by a local echocardiogram performed during screening, or a previously performed echocardiogram if collected within 6 months before screening. 7. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (DVT; including proximal and distal), pulmonary or arterial embolism, arterial thrombosis or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed. 8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimeters of mercury (mmHg) and/or diastolic blood pressure ≥100 mmHg despite adequate treatment. 9. Prior history of malignancies, other than MDS. Participants who are free of other malignant disease for ≥3 years and have completed treatment, including maintenance are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy: 1. Basal or squamous cell carcinoma of the skin; 2. Carcinoma in situ of the cervix; 3. Carcinoma in situ of the breast; 4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis \[TNM\] or early papillary thyroid cancer (Stage I \[T1-T2, N0, M0\]) clinical staging system). 10. History of solid organ or bone marrow transplantation. 11. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 14 days before randomization. 12. Known positive for human immunodeficiency virus (HIV), active infectious hepatitis B virus (HBV), or active infectious hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines. 13. Body mass index ≥ 40 kilograms per square meter (kg/m\^2). 14. Major surgery within 28 days before randomization. 15. New-onset seizures or poorly controlled seizures within 12 weeks prior to randomization are excluded from trial participation. 16. History of allergy/anaphylaxis to investigational product (including epoetin alfa) excipients (refer to the current elritercept investigator's brochure for a list of excipients) or recombination proteins. 17. History of pure red cell aplasia and/or antibody against erythropoietin (EPO). 18. Any of the following laboratory abnormalities: 1. ANC \<500/microliter (μL) (0.5×10\^9/liter \[L\]). 2. Platelet count \<50,000/μL (50×10\^9/L) or ≥800,000/μL (800×10\^9/L). 3. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3× upper limit of the normal (ULN). 4. Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin \<3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review. 5. Estimated glomerular filtration rate \<30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2) as determined by the Chronic Kidney Disease Epidemiology (CKD-EPI) collaboration equation. 6. Ferritin ≤50 micrograms per liter (μg/L). 7. Folate ≤2.0 nanograms per milliliter (ng/mL). 8. Vitamin B12 ≤200 picograms per milliliter (pg/mL). 19. Ongoing participation in another interventional clinical trial or use of any other investigational medicinal product within 5 times the half-life. 20. Participant is unwilling or in the opinion of the investigator the participant is unable to comply with the requirements of the protocol. 21. Is a participant of childbearing potential (POCBP) but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of trial intervention. 22. Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom during the entire trial intervention period until at least 60 days after the last dose of trial intervention. 23. If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire trial intervention period until at least 60 days after the last dose of trial intervention. 24. For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.

Conditions

Myelodysplastic Syndrome Anemia

Locations

Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
City of Hope - Comprehensive Cancer Center (CCC) — Duarte, California, United States
Providence Medical Group — Santa Rosa, California, United States
Cancer & Blood Research Center — Whittier, California, United States
Yale — New Haven, Connecticut, United States
University of Miami — Miami, Florida, United States
BRCR Medical Center Inc — Tamarac, Florida, United States
Moffitt Cancer Center — Tampa, Florida, United States
Emory University — Atlanta, Georgia, United States
Orchard Healthcare Research Inc. (OHR) - Skokie — Skokie, Illinois, United States
Norton Cancer Institute — Louisville, Kentucky, United States
Epic Medical Research — Monroe, Louisiana, United States
Epic Medical Research - Shreveport — Shreveport, Louisiana, United States
The Cancer and Hematology Centers — Grand Rapids, Michigan, United States
American Oncology Partners P.A. MidAmerica Cancer Care — Kansas City, Missouri, United States
Hematology Oncology Associates of Rockland — Nyack, New York, United States
Albert Einstein College - Montefiore — The Bronx, New York, United States
Novant Health Care Institute — Winston-Salem, North Carolina, United States
Cleveland clinic OH — Cleveland, Ohio, United States
Thomas Jefferson University — Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
Tennessee Oncology, PLLC — Nashville, Tennessee, United States
World Research Link — Baytown, Texas, United States
Texas Oncology - Denton — Denton, Texas, United States
The Center for Cancer and Blood Disorders — Fort Worth, Texas, United States
The University of Texas-MD Anderson Cancer Center - Leukemia Center — Houston, Texas, United States
LUMI Research — Houston, Texas, United States
Renovatio Clinical — The Woodlands, Texas, United States
Huntsman Cancer Institute — Salt Lake City, Utah, United States
Virginia Commonwealth University (VCU)-Medical Center - North Hospital — Richmond, Virginia, United States
West Virginia University Cancer Institute — Wheeling, West Virginia, United States
Instituto Medico de la Fundacion Estudios Clinicos — Rosario, Santa Fe Province, Argentina
Swiss Medical Center - Barrio Parque — Buenos Aires, Argentina
Sanatorio Allende S.A. - Nueva Cordoba — Córdoba, Argentina
Hospital Privado de Cordoba — Córdoba, Argentina
Mid North Coast Local Health District - Mid North Coast Cancer Institute (MNCCI) - Coffs Harbour — Coffs Harbour, New South Wales, Australia
South Eastern Sydney Local Health District — Sydney, New South Wales, Australia
Calvary Mater Newcastle — Waratah, New South Wales, Australia
Royal Adelaide Hospital — Adelaide, South Australia, Australia
Flinders Medical Centre — Bedford Park, South Australia, Australia
Monash University-Monash Medical Centre (MMC) - Clayton — Clayton, Victoria, Australia
St. Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia
Eastern Haematology & Oncology Group or Austin Hospital — Heidelberg, Victoria, Australia
Alfred Hospital — Richmond, Victoria, Australia
Fiona Stanley Hospital — Perth, Western Australia, Australia
Chu-Ucl Namur Site Godinne — Yvoir, Namur, Belgium
UZ Leuven — Leuven, Vlaams-Brabant, Belgium
AZ Delta (H.-Hartziekenhuis Roeselare-Menen vzw (HHRM)) - Campus Rumbeke — Roeselare, West Flanders, Belgium
D'OR Institute for Research and Education — Salvador, Estado de Bahia, Brazil
Porto Alegre Clinical Hospital (HCPA) — Porto Alegre, Rio Grande do Sul, Brazil
Hospital Mae de Deus, Clinical Research Unit - Cancer Institute — Porto Alegre, Rio Grande do Sul, Brazil
Centro de Hematologia e Oncologia (CHO) — Joinville, Santa Catarina, Brazil
Hospital Amaral Carvalho (HAC) — Jaú, São Paulo, Brazil
Irmandade da Santa Casa da Misericordia de Santos (ISCMS) — Santos, São Paulo, Brazil
Portuguese Charity of Sao Paulo, Clinical Hematology / Oncology Center — São Paulo, Brazil
Hospital 9 de Julho (Rede Americas/DASA) — São Paulo, Brazil
Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD) — Plovdiv, Bulgaria
Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology — Sofia, Bulgaria
Centre Hospitalier Universitaire Grenoble Alpes — La Tronche, Isere, France
Poitiers University Hospital Center - Miletrie Site — Poitiers, Vienne, France
Gustave Roussy — Villejuif, X, France
Centre Hospitalier Universitaire (CHU) de Nice - Hopital L'Archet I - Hematologie Clinique — Nice, France
Saint-Louis Hospital — Paris, France
Universitatsklinikum Bayreuth, Med. Klinik IV — Bayreuth, Bavaria, Germany
Gemeinschaftspraxis fuer Haematologie und Onkologie - Praxis Steinfurter Strasse — Münster, North Rhine-Westphalia, Germany
University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology — Halle, Saxony-Anhalt, Germany
Praxis am Volkspark — Berlin, Germany
Charite Campus Benjamin Franklin — Berlin, Germany
Laiko General Hospital — Athens, Central Athens, Greece
National and Kapodistrian University of Athens (NKUA)-Laiko General Hospital — Athens, Central Athens, Greece
Democritus University of Thrace (DUTH) - University General Hospital of Alexandroupolis — Alexandroupoli, Evros, Greece
General Hospital of Thessaloniki "Ippokratio" — Thessaloniki, Macedonia, Greece
National and Kapodistrian University of Athens-University General Hospital Attikon — Athens, West Athens, Greece
Faculty of Medicine, School of Health Sciences, University of Ioannina — Ioannina, Greece
University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology — Debrecen, H-B, Hungary
Szent Borbala Korhaz, Department of Internal Medicine and Haematology, Division of Hematology — Tatabánya, Komárom-Esztergom, Hungary
AIMS, Kochi — Kochi, Kerala, India
Tata Medical Center, Kolkata — Kochi, Kerala, India
Sahyadri Hospitals, Pune — Pune, Maharashtra, India
Christian Medical College — Vellore, Tamil Nadu, India
Apollo Hospital Hyderabad — Hyderabad, Telangana, India
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh — Chandigarh, India
Max SuperSpeciality Saket, Delhi — Delhi, India
Cork University Hospital — Cork, Ireland
St. James's Hospital — Dublin, Ireland
Mater Misericordiae University Hospital — Dublin, Ireland
University Hospital Galway — Galway, Ireland
Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) — Florence, Florence, Italy
Gruppo Humanitas-Humanitas Research Hospital (Istituto Clinico Humanitas) — Rozzano, Milan, Italy
Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology — Pavia, PV, Italy
Policlinico Umberto I — Roma, Rome, Italy
Institute of Cancer Research and Treatment of Candiolo — Candiolo, Torino, Italy
Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Lorenzo e Ariosto Seragnoli" — Bologna, Italy
IRCCS Ospedale San Raffaele — Milan, Italy
Ospedale Cardarelli — Naples, Italy
Ospedale di Novara — Novara, Italy
Universita degli Studi di Padova-Azienda Ospedaliera di Padova — Padua, Italy
Universita Degli Studi di Roma "Tor Vergata" — Rome, Italy
NHO Nagoya Medical Center — Nagoya, Aichi-ken, Japan
Fukushima Medical University Hospital — Fukushima, Fukushima, Japan, Japan
Gifu Municipal Hospital — Gifu, Gifu, Japan
Chugoku Central Hospital — Fukuyama-shi, Hiroshima, Japan
Hyogo Prefectural Amagasaki General Medical Center — Amagasaki-shi, Hyōgo, Japan
Dokkyo Medical University Hospital — Mibu, Tochigi, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital — Bunkyo-ku, Tokyo, Japan
NTT Medical Center Tokyo — Shinagawa-ku, Tokyo, Japan
Hospital of Lithuania University of Health Sciences Kaunas, Clinic of Oncology and Hematology — Kaunas, LT, Lithuania
Vilniaus Universiteto Ligonine Santaros Klinikos (VULSK) (Vilniaus Universiteto Ligonines Santariskiu Klinikos) — Vilnius, Lithuania
Hospital Sultanah Aminah Johor Bahru (HSAJB) — Johor Bahru, Johor, Malaysia
Hospital Sultanah Bahiyah (HSB) (Klinik Kesihatan Bandar Alor Setar/Hospital Alor Setar) — Alor Star, Kedah, Malaysia
Universiti Malaya - Faculty of Medicine (FOM) — Kuala Lumpur, Kuala Lumpur, Malaysia
Centro de Investigacion Clinica Chapultepec (CICC), S.A. de C.V — Morelia, Michoacán, Mexico
Universidad Autonoma de Nuevo Leon-Hospital Universitario "Dr. Jose Eleuterio Gonzalez" - Servicio de Hematologia — Monterrey, Nuevo León, Mexico
National Institute of Medical Sciences and Nutrition Salvado — Mexico City, Mexico
Oaxaca Site Management Organization S.C. - Oaxaca — Oaxaca City, Mexico
Amsterdam UMC-Locatie VUMC (Vrije Universiteit Medisch Centrum) — Amsterdam, North Holland, Netherlands
Sykehuset Vestfold HF — Tønsberg, Vestfold, Norway
Helse Bergen HF — Bergen, Vest, Norway
Oslo Universitetssykehus HF — Oslo, Norway
Pratia Wroclaw — Wroclaw, Lower Silesian Voivodeship, Poland
Pratia MCM Krakow — Krakow, maAopolska, Poland
Warszawski Uniwersytet Medyczny (WUM) (Medical University of Warsaw) — Warsaw, Masovian Voivodeship, Poland
Pratia Onkologia Katowice — Katowice, Silesian Voivodeship, Poland
AidPort — Skorzewo, Wielkopolska, Poland
Institutul Oncologic Prof. Dr. I. Chiricu — Cluj-Napoca, Cluj, Romania
Filantropia Municipal Clinical Hospital — Craiova, Dolj, Romania
Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea
Soon Chun Hyang University Hospital Seoul — Seoul, Yongsan-gu, South Korea
Korea University Anam Hospital — Seoul, South Korea
Seoul National University Hospital — Seoul, South Korea
Samsung Medical Center — Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul, South Korea
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals Location — L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS) — Seville, Seville, Spain
Hospital Universitari Vall d'Hebron-Institut de Recerca (VHIR) — Barcelona, Spain
University Hospital Ramon y Cajal — Madrid, Spain
Hospital Universitario Virgen de la Victoria (HUVV) — Málaga, Spain
Universidad de Salamanca - Hospital Universitario de Salamanca — Salamanca, Spain
University and Polytechnic Hospital La Fe — Valencia, Spain
Universitatsspital Zurich — Zurich, Canton of Zurich, Switzerland
Kantonsspital Graubunden — Chur, Kanton Graubünden, Switzerland
Insel Gruppe AG — Bern, Switzerland
China Medical University Hospital — Taichung, TW, Taiwan
Chang Bing Show Chwan Memorial Hospital — Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
National Cheng Kung University Hospital — Tainan, Taiwan
National Taiwan University Hospital - East Campus — Taipei, Taiwan
Taipei Veterans General Hospital — Taipei, Taiwan
Maharaj Nakorn Chiangmai Hospital — Chiang Mai, Chiang Mai, Thailand
Banphaeo General Hospital — Ban Phaeo, Samutsakorn, Thailand
King Chulalongkorn Memorial Hospital — Bangkok, Thailand
Ankara Universitesi, TAp FakAltesi, Hematoloji BD — Ankara, Ankara, Turkey, Turkey (Türkiye)
Ondokuz Mayis University School of Medicine, Department of Hematology — Samsun, Atakum, Turkey (Türkiye)
Mersin Medicalpark Hospital — Mersin, Mezitli, Turkey (Türkiye)
Istanbul Florence Nightingale Hospital — Istanbul, Turkey (Türkiye)
Ege University Medical Faculty — Izmir, Turkey (Türkiye)
University Hospitals of Leicester NHS Trust — Leicester, Leicestershire, United Kingdom
Pilgrim Hospital — Boston, Lincolnshire, United Kingdom
Churchill Hospital — Oxford, OXON, United Kingdom
Queen Elizabeth Hospital Birmingham — Birmingham, West Midlands, United Kingdom
King's College Hospital — London, United Kingdom
The Christie NHS Foundation Trust — Manchester, United Kingdom

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment