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RECRUITING

NCT07422480

PHASE3

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

Sponsor: Takeda

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-04-01

Completion Date

2033-10-01

Last Updated

2026-03-09

Healthy Volunteers

Conditions

Myelodysplastic Syndrome Anemia

Interventions

DRUG

Elritercept

Elritercept, SC, injection.

DRUG

Epoetin Alfa

Epoetin Alfa SC injection.

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 greater than (\>) 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 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. 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) after last RBC transfusion preceding 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. No other erythropoiesis-stimulating agent (ESA) agent is allowed. 2. Darbepoetin 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 8. Hematopoeitic cell transplant 9. 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. 10. Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed 11. High-dose corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone ≤10 mg/day or corticosteroid equivalent for ≥ 4 weeks are allowed. Other disease modifying treatments for autoimmune diseases may be allowed upon medical monitor review. 12. Investigational agent or any other agent intended for treatment MDS treatment 2. Diagnosed to have MDS associated with 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; due to iron, vitamin B12, vitamin B6, zinc, or folate deficiencies; autoimmune or hereditary hemolytic anemia; any type of known clinically significant bleeding or sequestration or drug induced anemia, hemolytic anemia, or bleeding events. 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 \[TNM\] 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) (0.5×109/L). 2. Platelet count \<50,000/μL (50×109/L) or ≥450,000/μL (450×109/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 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. 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.

Locations (146)

Hematology-Oncology Medical Group of Orange County, Inc - Orange - 1010 W. La Veta Avenue

Orange, California, United States

BRCR Medical Center Inc

Tamarac, 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

American Oncology Partners P.A. MidAmerica Cancer Care

Kansas City, Missouri, 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

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

World Research Link

Baytown, 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

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

Eastern Haematology & Oncology Group or Austin Hospital

Heidelberg, Victoria, Australia

Alfred Hospital

Melbourne, Victoria, Australia

Fiona Stanley Hospital

Murdoch, 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

Santa Casa de Misericordia-Porto Alegre

Porto Alegre, Rio Grande do Sul, 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

St. Paul's Hospital (SPH) - Vancouver

Vancouver, British Columbia, Canada

London Health Sciences Centre (LHSC) - Victoria Hospital

London, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Centre Hospitalier Universitaire Grenoble Alpes

La Tronche, Isere, France

Poitiers University Hospital Center - Miletrie Site

Poitiers, Vienne, France

Centre Hospitalier Universitaire (CHU) de Nice - Hopital L'Archet I - Hematologie Clinique

Nice, France

Saint-Louis Hospital

Paris, France

Gustave Roussy

Villejuif, 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

Goudi, 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, Hajdú-Bihar, Hungary

Szent Borbala Korhaz, Department of Internal Medicine and Haematology, Division of Hematology

Tatabánya, Komárom-Esztergom, Hungary

AIMS, Kochi

Kochi, Kerala, India

Sahyadri Hospitals, Pune

Pune, Maharashtra, India

Christian Medical College

Vellore, Tamil Nadu, India

Apollo Hospital Hyderabad

Hyderabad, Telangana, India

Tata Medical Center, Kolkata

Kolkata, West Bengal, India

Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

Chandigarh, India

Max SuperSpeciality Saket, Delhi

Delhi, India

Cork University Hospital

Cork, Ireland

Mater Misericordiae University Hospital

Dublin, Ireland

Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Lorenzo e Ariosto Seragnoli"

Bologna, Italy

Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)

Florence, 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

Padova, Italy

Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology

Pavia, Italy

Universita Degli Studi di Roma "Tor Vergata"

Rome, Italy

Policlinico Umberto I

Rome, Italy

Gruppo Humanitas-Humanitas Research Hospital (Istituto Clinico Humanitas)

Rozzano, Italy

Institute of Cancer Research and Treatment of Candiolo

Torino, Italy

NHO Nagoya Medical Center

Naka-ku, Aichi-ken, Japan

Gifu Municipal Hospital

Gifu, Gifu, Japan

Chugoku Central Hospital

Fukuyama, Hiroshima, Japan

Hyogo Prefectural Amagasaki General Medical Center

Amagasaki, Hyōgo, Japan

Dokkyo Medical University Hospital

Kitakobayashi, Tochigi, Japan

Fukushima Medical University Hospital

Fukushima, Tohoku, 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, 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)

George Town, 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

Oaxaca Site Management Organization S.C. - Oaxaca

Oaxaca City, Oaxaca, Mexico

National Institute of Medical Sciences and Nutrition Salvado

México, Mexico

Clinica Ruiz - Centro de Hematologia y Medicina Interna (CHMI)

Puebla 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

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

Chang Bing Show Chwan Memorial Hospital

Changhua, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital - East Campus

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Banphaeo General Hospital

Ban Phaeo, Samutsakorn, Thailand

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Maharaj Nakorn Chiangmai Hospital

Chiang Mai, Thailand

Ondokuz Mayis University School of Medicine, Department of Hematology

Samsun, Atakum, Turkey (Türkiye)

Mersin Medicalpark Hospital

Mersin, Mezitli, Turkey (Türkiye)

Ankara Universitesi, TAp FakAltesi, Hematoloji BD

Ankara, Turkey (Türkiye)

Istanbul Florence Nightingale Hospital

Istanbul, Turkey (Türkiye)

Ege University Medical Faculty

Izmir, Turkey (Türkiye)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (146)