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
ELRiSE MDS
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
2 other identifiers
interventional
300
28 countries
146
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2026
Longer than P75 for phase_3
146 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2026
CompletedFirst Posted
Study publicly available on registry
February 20, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2033
March 9, 2026
March 1, 2026
3.1 years
February 6, 2026
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Participants who are RBC Transfusion Independent (RBC-TI) for any Consecutive Greater Than Equal to (≥) 12-Week Period From Day 1 Through 24 Weeks With Concurrent Mean Hemoglobin (Hgb) Increase ≥ 1.5 Grams per Deciliter (g/dL) From Baseline
RBC-TI is defined as no red blood cell (RBC) transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Secondary Outcomes (28)
Proportion of Participants who are RBC-TI for any Consecutive ≥16-Week Period From Day 1 to 24 Weeks
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants who are RBC-TI for any Consecutive ≥12-Week Period From Day 1 to 24 Weeks
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants who are RBC-TI for a Consecutive 24-Week Period From Day 1
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants who Have Confirmed Meaningful Improvement or no Meaningful Deterioration in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score With no RBC Transfusions Between Week 12 to Week 24
From End of Week 12 to End of Week 24
Proportion of Participants who Achieved Hematological Improvement-Erythroid (HI-E) for a Minimum 8-Week Period From Day 1 to 24 Weeks
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
- +23 more secondary outcomes
Study Arms (2)
Elritercept
EXPERIMENTALParticipants will receive a starting dose of elritercept at 3.75 milligrams per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks, and may have the dose escalated to 5.0 mg/kg if needed,
Epoetin Alfa
ACTIVE COMPARATORParticipants will receive a starting dose of epoetin Alfa at 450 international units per kilograms (IU/kg) administered SC once every week, and may have the dose escalated up to 1050 IU/kg.
Interventions
Eligibility Criteria
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.
You may not qualify if:
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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
- +40 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (146)
Hematology-Oncology Medical Group of Orange County, Inc - Orange - 1010 W. La Veta Avenue
Orange, California, 92868, United States
BRCR Medical Center Inc
Tamarac, Florida, 33321, United States
Emory University
Atlanta, Georgia, 30322, United States
Orchard Healthcare Research Inc. (OHR) - Skokie
Skokie, Illinois, 60077, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
American Oncology Partners P.A. MidAmerica Cancer Care
Kansas City, Missouri, 64132, United States
Albert Einstein College - Montefiore
The Bronx, New York, 10467, United States
Novant Health Care Institute
Winston-Salem, North Carolina, 27106, United States
Cleveland clinic OH
Cleveland, Ohio, 44195, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
World Research Link
Baytown, Texas, 77521, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
The University of Texas-MD Anderson Cancer Center - Leukemia Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84124, United States
Virginia Commonwealth University (VCU)-Medical Center - North Hospital
Richmond, Virginia, 23298, United States
West Virginia University Cancer Institute
Wheeling, West Virginia, 26003, United States
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, Santa Fe Province, 2000, Argentina
Swiss Medical Center - Barrio Parque
Buenos Aires, 1425, Argentina
Sanatorio Allende S.A. - Nueva Cordoba
Córdoba, 5000, Argentina
Hospital Privado de Cordoba
Córdoba, X5000, Argentina
Mid North Coast Local Health District - Mid North Coast Cancer Institute (MNCCI) - Coffs Harbour
Coffs Harbour, New South Wales, 2450, Australia
South Eastern Sydney Local Health District
Sydney, New South Wales, 2217, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2282, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Monash University-Monash Medical Centre (MMC) - Clayton
Clayton, Victoria, 3168, Australia
Eastern Haematology & Oncology Group or Austin Hospital
Heidelberg, Victoria, 3084, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Chu-Ucl Namur Site Godinne
Yvoir, Namur, 5530, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
AZ Delta (H.-Hartziekenhuis Roeselare-Menen vzw (HHRM)) - Campus Rumbeke
Roeselare, West Flanders, 8800, Belgium
D'OR Institute for Research and Education
Salvador, Estado de Bahia, 41253-190, Brazil
Santa Casa de Misericordia-Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020090, Brazil
Porto Alegre Clinical Hospital (HCPA)
Porto Alegre, Rio Grande do Sul, 90035903, Brazil
Hospital Mae de Deus, Clinical Research Unit - Cancer Institute
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Centro de Hematologia e Oncologia (CHO)
Joinville, Santa Catarina, 89201-260, Brazil
Hospital Amaral Carvalho (HAC)
Jaú, São Paulo, 17210080, Brazil
Irmandade da Santa Casa da Misericordia de Santos (ISCMS)
Santos, São Paulo, 11075-101, Brazil
Portuguese Charity of Sao Paulo, Clinical Hematology / Oncology Center
São Paulo, 01321-001, Brazil
Hospital 9 de Julho (Rede Americas/DASA)
São Paulo, 01409-000, Brazil
Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD)
Plovdiv, 4000, Bulgaria
Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology
Sofia, 1756, Bulgaria
St. Paul's Hospital (SPH) - Vancouver
Vancouver, British Columbia, V6E 1M7, Canada
London Health Sciences Centre (LHSC) - Victoria Hospital
London, Ontario, N6A 5W9, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, Isere, 38700, France
Poitiers University Hospital Center - Miletrie Site
Poitiers, Vienne, 86021, France
Centre Hospitalier Universitaire (CHU) de Nice - Hopital L'Archet I - Hematologie Clinique
Nice, 06200, France
Saint-Louis Hospital
Paris, 75010, France
Gustave Roussy
Villejuif, 94805, France
Universitatsklinikum Bayreuth, Med. Klinik IV
Bayreuth, Bavaria, 95445, Germany
Gemeinschaftspraxis fuer Haematologie und Onkologie - Praxis Steinfurter Strasse
Münster, North Rhine-Westphalia, 48153, Germany
University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
Halle, Saxony-Anhalt, 06120, Germany
Praxis am Volkspark
Berlin, 10715, Germany
Charite Campus Benjamin Franklin
Berlin, 12200, Germany
Laiko General Hospital
Athens, Central Athens, 11526, Greece
National and Kapodistrian University of Athens (NKUA)-Laiko General Hospital
Goudi, Central Athens, 11527, Greece
Democritus University of Thrace (DUTH) - University General Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100, Greece
General Hospital of Thessaloniki "Ippokratio"
Thessaloniki, Macedonia, 55133, Greece
National and Kapodistrian University of Athens-University General Hospital Attikon
Athens, West Athens, 12462, Greece
Faculty of Medicine, School of Health Sciences, University of Ioannina
Ioannina, 45500, Greece
University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology
Debrecen, Hajdú-Bihar, 4032, Hungary
Szent Borbala Korhaz, Department of Internal Medicine and Haematology, Division of Hematology
Tatabánya, Komárom-Esztergom, 2800, Hungary
AIMS, Kochi
Kochi, Kerala, 682041, India
Sahyadri Hospitals, Pune
Pune, Maharashtra, 411004, India
Christian Medical College
Vellore, Tamil Nadu, 632517, India
Apollo Hospital Hyderabad
Hyderabad, Telangana, 500096, India
Tata Medical Center, Kolkata
Kolkata, West Bengal, 700160, India
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
Chandigarh, 160012, India
Max SuperSpeciality Saket, Delhi
Delhi, 110017, India
Cork University Hospital
Cork, T12 DC4A, Ireland
Mater Misericordiae University Hospital
Dublin, Dublin 7, Ireland
Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Lorenzo e Ariosto Seragnoli"
Bologna, 40138, Italy
Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)
Florence, 50141, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Ospedale Cardarelli
Naples, 80131, Italy
Ospedale di Novara
Novara, 28100, Italy
Universita degli Studi di Padova-Azienda Ospedaliera di Padova
Padua, 35128, Italy
Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology
Pavia, 27100, Italy
Universita Degli Studi di Roma "Tor Vergata"
Rome, 00133, Italy
Policlinico Umberto I
Rome, 00161, Italy
Gruppo Humanitas-Humanitas Research Hospital (Istituto Clinico Humanitas)
Rozzano, 20089, Italy
Institute of Cancer Research and Treatment of Candiolo
Torino, 10060, Italy
NHO Nagoya Medical Center
Naka-ku, Aichi-ken, 460-0001, Japan
Gifu Municipal Hospital
Gifu, Gifu, 500-8323, Japan
Chugoku Central Hospital
Fukuyama, Hiroshima, 720-0001, Japan
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Hyōgo, 660-8550, Japan
Dokkyo Medical University Hospital
Kitakobayashi, Tochigi, 321-0293, Japan
Fukushima Medical University Hospital
Fukushima, Tohoku, 960-1295, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, 113-8677, Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, 141-8625, Japan
Hospital of Lithuania University of Health Sciences Kaunas, Clinic of Oncology and Hematology
Kaunas, 50161, Lithuania
Vilniaus Universiteto Ligonine Santaros Klinikos (VULSK) (Vilniaus Universiteto Ligonines Santariskiu Klinikos)
Vilnius, 08661, Lithuania
Hospital Sultanah Aminah Johor Bahru (HSAJB)
Johor Bahru, Johor, 80100, Malaysia
Hospital Sultanah Bahiyah (HSB) (Klinik Kesihatan Bandar Alor Setar/Hospital Alor Setar)
George Town, Kedah, 11450, Malaysia
Universiti Malaya - Faculty of Medicine (FOM)
Kuala Lumpur, Kuala Lumpur, 59200, Malaysia
Centro de Investigacion Clinica Chapultepec (CICC), S.A. de C.V
Morelia, Michoacán, 58260, Mexico
Universidad Autonoma de Nuevo Leon-Hospital Universitario "Dr. Jose Eleuterio Gonzalez" - Servicio de Hematologia
Monterrey, Nuevo León, 64460, Mexico
Oaxaca Site Management Organization S.C. - Oaxaca
Oaxaca City, Oaxaca, 68000, Mexico
National Institute of Medical Sciences and Nutrition Salvado
México, 14080, Mexico
Clinica Ruiz - Centro de Hematologia y Medicina Interna (CHMI)
Puebla City, 72530, Mexico
Amsterdam UMC-Locatie VUMC (Vrije Universiteit Medisch Centrum)
Amsterdam, North Holland, 1081HV, Netherlands
Sykehuset Vestfold HF
Tønsberg, Vestfold, 3116, Norway
Helse Bergen HF
Bergen, Vest, 5021, Norway
Oslo Universitetssykehus HF
Oslo, 0372, Norway
Pratia Wroclaw
Wroclaw, Lower Silesian Voivodeship, 50-019, Poland
Pratia MCM Krakow
Krakow, maAopolska, 50-727, Poland
Warszawski Uniwersytet Medyczny (WUM) (Medical University of Warsaw)
Warsaw, Masovian Voivodeship, 02-172, Poland
Pratia Onkologia Katowice
Katowice, Silesian Voivodeship, 40-519, Poland
AidPort
Skorzewo, Wielkopolska, 60185, Poland
Institutul Oncologic Prof. Dr. I. Chiricu
Cluj-Napoca, Cluj, 400124, Romania
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, Yongsan-gu, 04401, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals Location
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
Seville, Seville, 41013, Spain
Hospital Universitari Vall d'Hebron-Institut de Recerca (VHIR)
Barcelona, 08035, Spain
University Hospital Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario Virgen de la Victoria (HUVV)
Málaga, 29010, Spain
Universidad de Salamanca - Hospital Universitario de Salamanca
Salamanca, 37007, Spain
University and Polytechnic Hospital La Fe
Valencia, 46026, Spain
Chang Bing Show Chwan Memorial Hospital
Changhua, 505029, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
China Medical University Hospital
Taichung, 404, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital - East Campus
Taipei, 100225, Taiwan
Taipei Veterans General Hospital
Taipei, 112201, Taiwan
Banphaeo General Hospital
Ban Phaeo, Samutsakorn, 74120, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Maharaj Nakorn Chiangmai Hospital
Chiang Mai, 50200, Thailand
Ondokuz Mayis University School of Medicine, Department of Hematology
Samsun, Atakum, 55270, Turkey (Türkiye)
Mersin Medicalpark Hospital
Mersin, Mezitli, 33000, Turkey (Türkiye)
Ankara Universitesi, TAp FakAltesi, Hematoloji BD
Ankara, 06520, Turkey (Türkiye)
Istanbul Florence Nightingale Hospital
Istanbul, 34381, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, 35100, Turkey (Türkiye)
Pilgrim Hospital
Boston, Lincolnshire, PE227BU, United Kingdom
Churchill Hospital
Oxford, OXON, OX3 7LE, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, B15 2TH, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2026
First Posted
February 20, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
April 30, 2029
Study Completion (Estimated)
October 1, 2033
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.