Myelodysplastic SyndromePhase 3ELRiSE MDSNCT07422480
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
A Phase 3 study testing Elritercept and Epoetin Alfa in people with Myelodysplastic Syndrome and Anemia, run by Takeda at 162 sites in 28 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome, Anemia
- What is being tested?
- Elritercept and Epoetin Alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 162 sitesin 28 countries
- Study dates
- 21 May 2026to 1 Oct 2033
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 > 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 (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.
- 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.
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- 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) before randomization. Local laboratory is acceptable to facilitate randomization.
- Eastern Cooperative Oncology Group score of 0, 1, or 2.
Who cannot join
- 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.
- 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.
- 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.
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- 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 for the disease under study.
- Hematopoeitic cell transplant
- Iron chelation if initiated ≤8 weeks prior to randomization. Participants on stable or decreasing 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 or decreasing 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
- 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.
- Investigational agent or any other agent intended for MDS treatment
- Diagnosed to have MDS with presence of del(5q) cytogenetic abnormality or MDS unclassifiable according to WHO 2016 classification or secondary MDS.
- Known history of diagnosis of acute myeloid leukemia (AML).
- 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).
- Clinically significant cardiovascular disease defined as:
- New York Heart Association heart disease class III or IV
- Fridericia corrected QT (QTcF) interval >500 milliseconds during screening
- Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening
- Known ejection fraction <35%, confirmed by a local echocardiogram performed during screening, or a previously performed echocardiogram if collected within 6 months before screening.
- 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.
- 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.
- 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:
- Basal or squamous cell carcinoma of the skin;
- Carcinoma in situ of the cervix;
- Carcinoma in situ of the breast;
- 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).
- History of solid organ or bone marrow transplantation.
- Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 14 days before randomization.
- 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.
- Body mass index ≥ 40 kilograms per square meter (kg/m^2).
- Major surgery within 28 days before randomization.
- New-onset seizures or poorly controlled seizures within 12 weeks prior to randomization are excluded from trial participation.
- 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.
- History of pure red cell aplasia and/or antibody against erythropoietin (EPO).
- Any of the following laboratory abnormalities:
- ANC <500/microliter (μL) (0.5×10^9/liter [L]).
- Platelet count <50,000/μL (50×10^9/L) or ≥800,000/μL (800×10^9/L).
- Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3× upper limit of the normal (ULN).
- 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.
- 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.
- Ferritin ≤50 micrograms per liter (μg/L).
- Folate ≤2.0 nanograms per milliliter (ng/mL).
- Vitamin B12 ≤200 picograms per milliliter (pg/mL).
- Ongoing participation in another interventional clinical trial or use of any other investigational medicinal product within 5 times the half-life.
- Participant is unwilling or in the opinion of the investigator the participant is unable to comply with the requirements of the protocol.
- 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.
- 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.
- 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.
- For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.
Trial locations and contacts
162 sites in 28 countries. Contact the study team or a site near you to ask about taking part.
162 sites in 28 countries
United States31 sites, 31 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Site Contact, 513-532-1948, nikolaos.papadantonakis@emory.edu
Nikolaos Papadantonakis
- Recruiting
World Research Link
Baytown, Texas, 77521
Site Contact, 833-832-8328, dramir.rasheed@worldresearchlink.com
Amir Rasheed
- Not yet recruiting
Cleveland clinic OH
Cleveland, Ohio, 44195
Site Contact, 216-287-5665, carrawh@ccf.org
Hetty Carraway
- Not yet recruiting
Texas Oncology - Denton
Denton, Texas, 76201
Site Contact
Charles Kurkul
- Not yet recruiting
City of Hope - Comprehensive Cancer Center (CCC)
Duarte, California, 91010
Site Contact, 626-218-2404, aartz@coh.org
Andrew Artz
- Recruiting
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
Site Contact, 817-759-7000, ray_page@txcc.com
Ray Page
- Not yet recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Site Contact
Mark Faber
- Not yet recruiting
The Cancer and Hematology Centers
Grand Rapids, Michigan, 49503
Site Contact, 616-954-5550, dfoley@thechc.com
Daniel Foley
- Recruiting
The University of Texas-MD Anderson Cancer Center - Leukemia Center
Houston, Texas, 77030
Site Contact, 713-745-3428, ggarciam@mdanderson.org
Guillermo Garcia-Manero
- Recruiting
LUMI Research
Houston, Texas, 77090
Site Contact
David Nguyen
- Recruiting
American Oncology Partners P.A. MidAmerica Cancer Care
Kansas City, Missouri, 64132
Site Contact, 816-974-5050, benjamin.fangman@aoncology.com
Benjamin Fangman
- Recruiting
Norton Cancer Institute
Louisville, Kentucky, 40207
Site Contact, 502-899-3366, don.stevens@nortonhealthcare.org
Don Stevens
- Not yet recruiting
University of Miami
Miami, Florida, 33136
Site Contact, 305-243-9974, msekeres@med.miami.edu
Mikkael Sekeres
- Not yet recruiting
Epic Medical Research
Monroe, Louisiana, 71201
Site Contact, 972-777-6956, TGhattas@epicmedresearch.com
Tharwat Ghattas
- Recruiting
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Site Contact, 877-836-6662, clogothetis@tnonc.com
Constantine Logothetis
- Not yet recruiting
Yale
New Haven, Connecticut, 06510
Site Contact, 203-432-4771, amer.zeidan@yale.edu
Amer Zeidan
- Not yet recruiting
Hematology Oncology Associates of Rockland
Nyack, New York, 10960
Site Contact, 845-348-8516, slee19@montefiorenyack.org
Sung Ho Lee
- Not yet recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Site Contact, 215-955-8874, lindsay.wilde@jefferson.edu
Lindsay Wilde
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Site Contact, 215-534-8529, Iberia.sosa@fccc.edu
Iberia Sosa
- Not yet recruiting
Virginia Commonwealth University (VCU)-Medical Center - North Hospital
Richmond, Virginia, 23298
Site Contact, 804-828-2177, ruchi.desai@vcuhealth.org
Ruchi Desai
- Not yet recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84124
Site Contact, 801-587-7604, zaker.schwabkey@hci.utah.edu
Zaker Schwabkey
- Not yet recruiting
Providence Medical Group
Santa Rosa, California, 95403
Site Contact, jarrod.holmes@providence.org
Jarrod Holmes
- Not yet recruiting
Epic Medical Research - Shreveport
Shreveport, Louisiana, 71106
Site Contact, 972-777-6956, KKoticha@epicmedresearch.com
Kirtan Koticha
- Recruiting
Orchard Healthcare Research Inc. (OHR) - Skokie
Skokie, Illinois, 60077
Site Contact, 224-534-7580, ira.oliff@orchardhr.com
Ira Oliff
- Recruiting
BRCR Medical Center Inc
Tamarac, Florida, 33321
Site Contact, 561-447-0614, cgandhi.md@brcrglobal.com
Chintan Gandhi
- Not yet recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Site Contact, 813-745-4291, rami.komrokji@moffitt.org
Rami Komrokji
- Recruiting
Albert Einstein College - Montefiore
The Bronx, New York, 10467
Site Contact, 201-618-4725, ashastri@montefiore.org
Aditi Shastri
- Not yet recruiting
Renovatio Clinical
The Woodlands, Texas, 77380
Site Contact, 713-703-2398, mahran.shoukier@renovatioclinical.com
Mahran Shoukier
- Recruiting
West Virginia University Cancer Institute
Wheeling, West Virginia, 26003
Site Contact, 304-243-6442, bhavana.bhatnagar1@hsc.wvu.edu
Konstantinos Sdrimas
- Not yet recruiting
Cancer & Blood Research Center
Whittier, California, 90270
Site Contact
Merrill Shum
- Not yet recruiting
Novant Health Care Institute
Winston-Salem, North Carolina, 27106
Site Contact, 336-718-5570, jpdugan@novanthealth.org
James Dugan
Italy11 sites, 11 recruiting
- Not yet recruiting
Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Lorenzo e Ariosto Seragnoli"
Bologna, 40138
Site Contact, 0512143740, stefania.paolini@unibo.it
Stefania Paolini
- Recruiting
Institute of Cancer Research and Treatment of Candiolo
Candiolo, Torino, 10060
Site Contact, 0119933842, elena.crisa@ircc.it
Elena Crisa
- Recruiting
Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)
Florence, Florence, 50141
Site Contact, 0557946647, valeria.santini@unifi.it
Valeria Santini
- Not yet recruiting
IRCCS Ospedale San Raffaele
Milan, 20132
Site Contact, 022643, diral.elisa@hsr.it
Elisa Diral
- Recruiting
Ospedale Cardarelli
Naples, 80131
Site Contact, 817472241, mario.annunziata@aocardarelli.it
Mario Annunziata
- Recruiting
Ospedale di Novara
Novara, 28100
Site Contact, 03213732194, andrea.patriarca@uniupo.it
Andrea Patriarca
- Not yet recruiting
Universita degli Studi di Padova-Azienda Ospedaliera di Padova
Padua, 35128
Site Contact, 390498217091, gianni.binotto@unipd.it
Gianni Binotto
- Not yet recruiting
Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology
Pavia, PV, 27100
Site Contact, 0382503084, luca.malcovati@unipv.it
Luca Malcovati
- Not yet recruiting
Policlinico Umberto I
Roma, Rome, 00161
Site Contact, 0649974440, massimo.breccia@uniroma1.it
Massima Breccia
- Not yet recruiting
Universita Degli Studi di Roma "Tor Vergata"
Rome, 00133
Site Contact, 3494743547, voso@med.uniroma2.it
Maria Teresa Voso
- Not yet recruiting
Gruppo Humanitas-Humanitas Research Hospital (Istituto Clinico Humanitas)
Rozzano, Milan, 20089
Site Contact, matteo.della_porta@hunimed.eu
Matteo Giovanni Della Porta
Australia10 sites, 10 recruiting
- Not yet recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Site Contact, 0870740000, devendra.hiwase@sa.gov.au
Devendra Hiwase
- Not yet recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
Site Contact, 61882045209, ashanka.beligaswatte@sa.gov.au
Ashanka Beliasgwatte
- Not yet recruiting
Monash University-Monash Medical Centre (MMC) - Clayton
Clayton, Victoria, 3168
Site Contact, 0412633726, jake.shortt@monashhealth.org
Jake Shortt
- Not yet recruiting
Mid North Coast Local Health District - Mid North Coast Cancer Institute (MNCCI) - Coffs Harbour
Coffs Harbour, New South Wales, 2450
Site Contact, 0439119527, kyle.crassini@health.nsw.gov.au
Kyle Crassini
- Not yet recruiting
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
Site Contact, 613 9231 2211, shuhying.tan@svha.org.au
Shuhying Tan
- Recruiting
Eastern Haematology & Oncology Group or Austin Hospital
Heidelberg, Victoria, 3084
Site Contact, 0423085180, chun.fong@austin.org.au
Chun Yew Fong
- Not yet recruiting
Fiona Stanley Hospital
Perth, Western Australia, 6150
Site Contact, 0421428486, jasmine.singh2@health.wa.gov.au
Jasmine Singh
- Not yet recruiting
Alfred Hospital
Richmond, Victoria, 3004
Site Contact, 61430509338, s.fleming2@alfred.org.au
Shaun Fleming
- Not yet recruiting
South Eastern Sydney Local Health District
Sydney, New South Wales, 2217
Site Contact, 0291131111, sundra.ramanathan@health.nsw.gov.au
Sundreswran Ramanathan
- Not yet recruiting
Calvary Mater Newcastle
Waratah, New South Wales, 2282
Site Contact, 40143021, Anoop.Enjeti@calvarymater.org.au
Anoop Enjeti
Brazil8 sites, 8 recruiting
- Not yet recruiting
Hospital Amaral Carvalho (HAC)
Jaú, São Paulo, 17210080
Site Contact, +55 14 3602-1397, pesquisafac.edersonmattos@gmail.com
Ederson Mattos
- Recruiting
Centro de Hematologia e Oncologia (CHO)
Joinville, Santa Catarina, 89201-260
Site Contact, +55 47 34331849, acdalloglio@gmail.com
Ana Claudia Dall'Oglio
- Not yet recruiting
Porto Alegre Clinical Hospital (HCPA)
Porto Alegre, Rio Grande do Sul, 90035903
Site Contact, 555133596335, fogliattolaura@gmail.com
Laura Maria Fogliatto
- Recruiting
Hospital Mae de Deus, Clinical Research Unit - Cancer Institute
Porto Alegre, Rio Grande do Sul, 90110-270
Site Contact, +55 51 33072943, marcelocapra.pesquisa@gmail.com
Marcelo Capra
- Not yet recruiting
D'OR Institute for Research and Education
Salvador, Estado de Bahia, 41253-190
Site Contact, +55 11 95089-926, lainefiscina@gmail.com
Laine Santos Fiscina Alvarenga
- Not yet recruiting
Irmandade da Santa Casa da Misericordia de Santos (ISCMS)
Santos, São Paulo, 11075-101
Site Contact, 5501332020600, elaine_mancilha@hotmail.com
Elaine Mancilha
- Not yet recruiting
Portuguese Charity of Sao Paulo, Clinical Hematology / Oncology Center
São Paulo, 01321-001
Site Contact, 5511 3505-6687, scheinbp@gmail.com
Phillip Scheinberg
- Recruiting
Hospital 9 de Julho (Rede Americas/DASA)
São Paulo, 01409-000
Site Contact, +55 11 31479999, viniciuscamposdemolla@gmail.com
Vinicius Molla
Japan8 sites, 8 recruiting
- Recruiting
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki-shi, Hyōgo, 660-8550
Site Contact, +81-6-6480-7000, watanabemt@hp.pref.hyogo.jp
Mitsumasa Watanabe
- Recruiting
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, 113-8677
Site Contact, +81-(0)3-3823-2101, tomomi_tobai@tmhp.jp
Tomomi Tobai
- Recruiting
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan, 960-1295
Site Contact, +81-24-547-1111
Takayuki Ikezoe
- Recruiting
Chugoku Central Hospital
Fukuyama-shi, Hiroshima, 720-0001
Site Contact, 084-970-2121, makita-masanori@kouritu-cch.jp
Masanori Makita
- Recruiting
Gifu Municipal Hospital
Gifu, Gifu, 500-8323
Site Contact, +81-(0)58-251-1101, skasahara@hematology.ichinaika.gifu.jp
Senji Kasahara
- Recruiting
Dokkyo Medical University Hospital
Mibu, Tochigi, 321-0293
Site Contact, +81-(0)282-86-1111, y-imai524@dokkyomed.ac.jp
Yoichi Imai
- Recruiting
NHO Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001
Site Contact, +81-(0)52-951-1111, iida.hiroatsu.kr@mail.hosp.go.jp
Hiroatsu Iida
- Recruiting
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, 141-8625
Site Contact, +81-3-3448-6111, motoshi-tky@umin.ac.jp
Motoshi Ichikawa
India7 sites, 7 recruiting
- Not yet recruiting
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
Chandigarh, 160012
Site Contact, malhotra.pankaj@pgimer.edu.in
Pankaj Malhotra
- Not yet recruiting
Max SuperSpeciality Saket, Delhi
Delhi, 110017
Site Contact, 8826033518, Rayaz.khalid@maxhealthcare.com
Rayaz Ahmed
- Not yet recruiting
Apollo Hospital Hyderabad
Hyderabad, Telangana, 500096
Site Contact, 9553077700, drloki2002@yahoo.com
Padmaja Lokireddy
- Not yet recruiting
AIMS, Kochi
Kochi, Kerala, 682041
Site Contact, 9946047464, neerajsidh@gmail.com
Neeraj Sidharthan
- Not yet recruiting
Tata Medical Center, Kolkata
Kochi, Kerala, 682041
Site Contact, 9946047464, drarijitnag@gmail.com
Arijit Nag
- Not yet recruiting
Sahyadri Hospitals, Pune
Pune, Maharashtra, 411004
Site Contact, 9175980913, shashikant.apte@gmail.com
Shashikant Apte
- Not yet recruiting
Christian Medical College
Vellore, Tamil Nadu, 632517
Site Contact, 04172224461, biju@cmcvellore.ac.in
Biju George
Spain7 sites, 7 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron-Institut de Recerca (VHIR)
Barcelona, 8035
Site Contact, +34 639073048, dvalcarcel@vhio.net
David Valcarcel Ferreiras
- Not yet recruiting
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals Location
L'Hospitalet de Llobregat, Barcelona, 08908
Site Contact, 932067782, marnan@iconcologia.net
Montserrat Arnan Sangerman
- Not yet recruiting
University Hospital Ramon y Cajal
Madrid, 28034
Site Contact, 635844645, kyra.vkennedy@gmail.com
Kyra Velazquez Kennedy
- Recruiting
Hospital Universitario Virgen de la Victoria (HUVV)
Málaga, 29010
Site Contact, 434-951037650, reginagarciadel@yahoo.es
Regina Garcia-Delgado
- Recruiting
Universidad de Salamanca - Hospital Universitario de Salamanca
Salamanca, 37007
Site Contact, 34923291100, mdiezcampelo@usal.es
Maria Diez Campelo
- Not yet recruiting
Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
Seville, Seville, 41013
Site Contact, +34 661 640 480, josef.falantes.sspa@juntadeandalucia.es
Jose Francisco Falantes Gonzalez
- Recruiting
University and Polytechnic Hospital La Fe
Valencia, 46026
Site Contact, 34961245152, mora_elv@gva.es
Elvira Mora Castera
Greece6 sites, 6 recruiting
- Not yet recruiting
Democritus University of Thrace (DUTH) - University General Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
Site Contact, 302551352218, ikotsian@med.duth.gr
Ioannis Kotsianidis
- Not yet recruiting
Laiko General Hospital
Athens, Central Athens, 11526
Site Contact, theopvass@hotmail.com
Theodoros Vassilakopoulos
- Recruiting
National and Kapodistrian University of Athens (NKUA)-Laiko General Hospital
Athens, Central Athens, 11527
Site Contact, +30 6976776260, pandiamantopoulos@gmail.com
Panagiotis Diamantopoulos
- Not yet recruiting
National and Kapodistrian University of Athens-University General Hospital Attikon
Athens, West Athens, 12462
Site Contact, 6937255084, vas_pappa@yahoo.com
Vassiliki Pappa
- Recruiting
Faculty of Medicine, School of Health Sciences, University of Ioannina
Ioannina, 45500
Site Contact, 2651099650, ehatzim@uoi.gr
Eleftheria Hatzimichael
- Recruiting
General Hospital of Thessaloniki "Ippokratio"
Thessaloniki, Macedonia, 55133
Site Contact, 6973841671, elenicelli@yahoo.gr
Eleni Gavriilaki
South Korea6 sites, 6 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Site Contact, 01027609350, smbang7@snu.ac.kr
Soo-Mee Bang
- Recruiting
Soon Chun Hyang University Hospital Seoul
Seoul, Yongsan-gu, 04401
Site Contact, 010-9267-2281, ysy6496@schmc.ac.kr
Seug Yun Yoon
- Recruiting
Korea University Anam Hospital
Seoul, 02841
Site Contact, =82-2-920-5981, paark76@hanmail.net
Yong Park
- Recruiting
Seoul National University Hospital
Seoul, 03080
Site Contact, +82 2 2072 3383, hongjblood@snu.ac.kr
Junshik Hong
- Recruiting
Samsung Medical Center
Seoul, 06351
Site Contact, 01099330918, smcjunhojang@gmail.com
Jun Ho Jang
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Site Contact, 0222586057, yoojink@catholic.ac.kr
Yoo-Jin Kim
Taiwan6 sites, 6 recruiting
- Recruiting
Chang Bing Show Chwan Memorial Hospital
Changhua, 505029
Site Contact, 886937738728, cs4816@gmail.com
Cheng-Shyong Chang
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Site Contact, 886936805375, ycliu@kmu.edu.tw
Yi-Chang Liu
- Recruiting
China Medical University Hospital
Taichung, TW, 404
Site Contact, 886 975680836, supengyeh@gmail.com
Su-Peng Yeh
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
Site Contact, +886-62353535, ext 4620, teresa@mail.ncku.edu.tw
Tsai-Yun Chen
- Recruiting
National Taiwan University Hospital - East Campus
Taipei, 100225
Site Contact, 886972652285, hsinanhou@gmail.com
Chien-Chin Lin
- Recruiting
Taipei Veterans General Hospital
Taipei, 112201
Site Contact, -966677334, chiajenliu@gmail.com
Chia-Jen Liu
United Kingdom6 sites, 6 recruiting
- Not yet recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, B15 2TH
Site Contact, 0121 371 4351, vidhya.murthy2@uhb.nhs.uk
Vidhya Murthy
- Recruiting
Pilgrim Hospital
Boston, Lincolnshire, PE227BU
Site Contact, 01205446016, ciro.rinaldi@ulh.nhs.uk
Ciro Rinaldi
- Not yet recruiting
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE1 5WW
Site Contact, 0116 258 5501, matthew.lee3@nhs.net
Matthew Lee
- Recruiting
King's College Hospital
London, SE5 9RS
Site Contact, 02032991039, austin.kulasekararaj@nhs.net
Austin Kulasekararaj
- Not yet recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Site Contact, 01614468578, daniel.wiseman@nhs.net
Daniel Wiseman
- Not yet recruiting
Churchill Hospital
Oxford, OXON, OX3 7LE
Site Contact, 01865225336, oni.chowdhury@ouh.nhs.uk
Oni Chowdhury
France5 sites, 5 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, Isere, 38700
Site Contact, 0476768601, mmeunier2@chu-grenoble.fr
Mathieu Meunier
- Recruiting
Centre Hospitalier Universitaire (CHU) de Nice - Hopital L'Archet I - Hematologie Clinique
Nice, 06200
Site Contact, 0681369350, cluzeau.t@chu-nice.fr
Thomas Cluzeau
- Not yet recruiting
Saint-Louis Hospital
Paris, 75010
Site Contact, 33 (0)1 71 20 70 21, lionel.ades@aphp.fr
Lionel Ades
- Recruiting
Poitiers University Hospital Center - Miletrie Site
Poitiers, Vienne, 86021
Site Contact, 0549444444, Jose-Miguel.TORREGROSA-DIAZ@chu-poitiers.fr
Jose Miguel Torregrosa-Diaz
- Not yet recruiting
Gustave Roussy
Villejuif, X, 94805
Site Contact, 330142112379, christophe.willekens@gustaveroussy.fr
Christophe Willekens
Germany5 sites, 5 recruiting
- Recruiting
Universitatsklinikum Bayreuth, Med. Klinik IV
Bayreuth, Bavaria, 95445
Site Contact, 00499214006302, alexander.kiani@klinikum-bayreuth.de
Alexander Kiani
- Recruiting
Praxis am Volkspark
Berlin, 10715
Site Contact, +49(0)3084723535, jp.habbel@praxis-am-volkspark-berlin.de
Jan-Piet Habbel
- Recruiting
Charite Campus Benjamin Franklin
Berlin, 12200
Site Contact, 4930450613578, kathrin.rieger@charite.de
Kathrin Rieger
- Not yet recruiting
University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
Halle, Saxony-Anhalt, 06120
Site Contact, +49 345 557 7719, haifa.al-ali@uk-halle.de
Haifa Al-Ali
- Recruiting
Gemeinschaftspraxis fuer Haematologie und Onkologie - Praxis Steinfurter Strasse
Münster, North Rhine-Westphalia, 48153
Site Contact, +49 2519764537, liersch@onkologie-muenster.de
Ruediger Liersch
Poland5 sites, 5 recruiting
- Recruiting
Pratia Onkologia Katowice
Katowice, Silesian Voivodeship, 40-519
Site Contact, 48501714019, sgrosicki@wp.pl
Sebastian Grosicki
- Not yet recruiting
Pratia MCM Krakow
Krakow, maAopolska, 50-727
Site Contact, 48604276787, wojciech.jurczak@pratia.com
Wojciech Jurczak
- Recruiting
AidPort
Skorzewo, Wielkopolska, 60185
Site Contact, 793602210, michal.kwiatek@aidport.pl
Michael Kwiatek
- Recruiting
Warszawski Uniwersytet Medyczny (WUM) (Medical University of Warsaw)
Warsaw, Masovian Voivodeship, 02-172
Site Contact, 693351797, kmadry@wum.edu.pl
Krzysztof Madry
- Recruiting
Pratia Wroclaw
Wroclaw, Lower Silesian Voivodeship, 50-019
Site Contact, 48530309071, elzbietakalicinska@gmail.com
Elzbieta Kalicinska
Turkey (Türkiye)5 sites, 5 recruiting
- Not yet recruiting
Ankara Universitesi, TAp FakAltesi, Hematoloji BD
Ankara, Ankara, Turkey, 06520
Site Contact, 05055025302, topcuoglupervin@gmail.com
Pervin Topcuoglu
- Not yet recruiting
Istanbul Florence Nightingale Hospital
Istanbul, 34381
Site Contact, 00905437870708, omurgok17@hotmail.com
Omur Gokmen Sevindik
- Not yet recruiting
Ege University Medical Faculty
Izmir, 35100
Site Contact, 905325566128, saydamguray@yahoo.com
Guray Saydam
- Not yet recruiting
Mersin Medicalpark Hospital
Mersin, Mezitli, 33000
Site Contact, 905323460767, aniltombak@yahoo.com
Anil Tombak
- Not yet recruiting
Ondokuz Mayis University School of Medicine, Department of Hematology
Samsun, Atakum, 55139
Site Contact, 90 (505) 272 2289, engin.kelkitli55@gmail.com
Engin Kelkitli
Argentina4 sites, 4 recruiting
- Recruiting
Swiss Medical Center - Barrio Parque
Buenos Aires, 1425
Site Contact, +54 91169816300, miastrebner@gmail.com
Claudio Marcelo Iastrebner
- Not yet recruiting
Sanatorio Allende S.A. - Nueva Cordoba
Córdoba, 5000
Site Contact, 03516657011, gjarchu.sa@gmail.com
Gustavo D Jarchum
- Not yet recruiting
Hospital Privado de Cordoba
Córdoba, X5000
Site Contact, +549 0351 4688200, ana.basquiera@hospitalpiado.com.ar
Ana Basquiera
- Recruiting
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, Santa Fe Province, 2000
Site Contact, 03416149225, gustavobraidot@consultoriosintegrados.org
Gustavo Jorge Braidot
Ireland4 sites, 4 recruiting
- Recruiting
Cork University Hospital
Cork, T12 DC4A
Site Contact, +353 (0)21 4920347, vitaliy.mykytiv@hse.ie
Vitaliy Mykytiv
- Not yet recruiting
St. James's Hospital
Dublin, 091 524411
Site Contact, 353 1 410 3991, cmflynn@stjames.ie
Catherine Flynn
- Recruiting
Mater Misericordiae University Hospital
Dublin, Dublin 7
Site Contact, 35318034831, SuMaung@mater.ie
Su Maung
- Not yet recruiting
University Hospital Galway
Galway, H91 YR71
Site Contact, 353 091 524411, janusz.krawczyk@hse.ie
Janusz Krawczyk
Mexico4 sites, 4 recruiting
- Not yet recruiting
National Institute of Medical Sciences and Nutrition Salvado
Mexico City, 14080
Site Contact, 5537587499, eliapanda08@gmail.com
Elia Apodaca
- Not yet recruiting
Universidad Autonoma de Nuevo Leon-Hospital Universitario "Dr. Jose Eleuterio Gonzalez" - Servicio de Hematologia
Monterrey, Nuevo León, 64460
Site Contact, 8186756718, dgomezalmaguer@gmail.com
David Gomez Almaguer
- Not yet recruiting
Centro de Investigacion Clinica Chapultepec (CICC), S.A. de C.V
Morelia, Michoacán, 58260
Site Contact, 524431478545, gregorio_campos@hotmail.com
Gregorio Campos Cabrera
- Not yet recruiting
Oaxaca Site Management Organization S.C. - Oaxaca
Oaxaca City, 68000
Site Contact, 9515147056, eva.ramirez@osmomexico.com
Eva Fabiola Ramirez Romero
Belgium3 sites, 3 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Site Contact, 16346890, marielle.beckers@uzleuven.be
Marielle Beckers
- Recruiting
AZ Delta (H.-Hartziekenhuis Roeselare-Menen vzw (HHRM)) - Campus Rumbeke
Roeselare, West Flanders, 8800
Site Contact, 051237322, dries.deeren@azdelta.be
Dries Deeren
- Recruiting
Chu-Ucl Namur Site Godinne
Yvoir, Namur, 5530
Site Contact, 081423886, francois.dachy@chuuclnamur.uclouvain.be
FRANCOIS DACHY
Malaysia3 sites, 3 recruiting
- Recruiting
Hospital Sultanah Bahiyah (HSB) (Klinik Kesihatan Bandar Alor Setar/Hospital Alor Setar)
Alor Star, Kedah, 11450
Site Contact, +60 12 4281842, liewhongkeng@gmail.com
Liew Hong Keng
- Recruiting
Hospital Sultanah Aminah Johor Bahru (HSAJB)
Johor Bahru, Johor, 80100
Site Contact, 60127831871, yihseong@gmail.com
Wong Yih Seong
- Recruiting
Universiti Malaya - Faculty of Medicine (FOM)
Kuala Lumpur, Kuala Lumpur, 59200
Site Contact, 0123048771, pcbee@um.edu.my
Bee Ping Chong
Norway3 sites, 3 recruiting
- Recruiting
Helse Bergen HF
Bergen, Vest, 5021
Site Contact, 004792330302, asmr@helse-bergen.no
Astrid Olsnes
- Not yet recruiting
Oslo Universitetssykehus HF
Oslo, 0372
Site Contact, +47 99231135, xasyto@ous-hf.no
Synne Torkildsen
- Recruiting
Sykehuset Vestfold HF
Tønsberg, Vestfold, 3116
Site Contact, 4799741879, emil.nyquist@siv.no
Emil Nyquist
Switzerland3 sites, 3 recruiting
- Not yet recruiting
Insel Gruppe AG
Bern, 3010
Site Contact, 41 31 66 4 21 69, natalia.baran@insel.ch
Natalia Baran
- Not yet recruiting
Kantonsspital Graubunden
Chur, Kanton Graubünden, 7000
Site Contact, 41 81 25 66 646, tobias.silzle@ksgr.ch
Tobias Silzle
- Not yet recruiting
Universitatsspital Zurich
Zurich, Canton of Zurich, 8091
Site Contact, 41 43 253 93 20, stefan.balabanov@usz.ch
Stefan Balabanov
Thailand3 sites, 3 recruiting
- Recruiting
Banphaeo General Hospital
Ban Phaeo, Samutsakorn, 74120
Site Contact, 660896813505, busakorn.bgh@yahoo.com
Busakorn Sae-Aeng
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Site Contact, 0648415170, drnoppacharn@yahoo.com
Noppacharn Uaprasert
- Recruiting
Maharaj Nakorn Chiangmai Hospital
Chiang Mai, Chiang Mai, 50200
Site Contact, 66892664387, thanawat.r@cmu.ac.th
Thanawat Rattanathammethee
Bulgaria2 sites, 2 recruiting
- Recruiting
Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD)
Plovdiv, 4000
Site Contact, 00359888520139, penchogeorgiev@yahoo.com
Pencho Georgiev
- Recruiting
Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology
Sofia, 1756
Site Contact, 359879104960, t.yankova@hematology.bg
Tanya Yankova
Hungary2 sites, 2 recruiting
- Recruiting
University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology
Debrecen, H-B, 500096
Site Contact, 9553077700, illesarpaddr@gmail.com
Arpad Illes
- Recruiting
Szent Borbala Korhaz, Department of Internal Medicine and Haematology, Division of Hematology
Tatabánya, Komárom-Esztergom, 2800
Site Contact, 06204119459, zsocogo@gmail.com
Zsofia Simon
Lithuania2 sites, 2 recruiting
- Recruiting
Hospital of Lithuania University of Health Sciences Kaunas, Clinic of Oncology and Hematology
Kaunas, LT, 50161
Site Contact, 37061484658, milda.rudzianskiene@kaunoklinikos.lt
Milda Rudzianskiene
- Not yet recruiting
Vilniaus Universiteto Ligonine Santaros Klinikos (VULSK) (Vilniaus Universiteto Ligonines Santariskiu Klinikos)
Vilnius, 08661
Site Contact, 37067208917, andrius.degulys@santa.lt
Andrius Degulys
Romania2 sites, 2 recruiting
- Recruiting
Institutul Oncologic Prof. Dr. I. Chiricu
Cluj-Napoca, Cluj, 400124
Site Contact, 0040741337480, ciprian.tomuleasa@gmail.com
Ciprian Tomuleasa
- Recruiting
Filantropia Municipal Clinical Hospital
Craiova, Dolj, 20014
Site Contact
Luminita Ocroteala
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC-Locatie VUMC (Vrije Universiteit Medisch Centrum)
Amsterdam, North Holland, 1081HV
Site Contact, -4442575, a.vandeloosdrecht@amsterdamumc.nl
Arjan A. van de Loosdrecht
About this study
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
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.
- Conditions
- Myelodysplastic Syndrome, Anemia
- Being tested
- Elritercept, Epoetin Alfa
- Keywords
- TAK-226, Drug therapy
- Medical subject headings
- Myelodysplastic Syndromes, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElriterceptDrug
Also called TAK-226
Elritercept, SC injection.
Epoetin AlfaDrug
Epoetin Alfa, SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Elritercept | Experimental | Participants will receive elritercept at a starting dose of 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. Receives: Drug: Elritercept |
| Epoetin Alfa | Active comparator | Participants will receive epoetin alfa at a starting dose of 450 international units per kilograms (IU/kg) administered SC once every week, and may have the dose escalated up to 1050 IU/kg (maximum 80,000 IU). Receives: Drug: Epoetin Alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
Measured: 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
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
Measured: 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
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
Measured: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants Who Have Meaningful Improvement or Maintain a High Score With no Meaningful Deterioration in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score With no RBC Transfusions Based on the Average of Scores
The FACT-An questionnaire is used to assess the effects of disease symptoms on functioning and well-being in participants with anemia. The FACT-An Anemia scale includes 13 fatigue-specific items (which together comprise the FACIT-Fatigue scale).
Measured: 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
HI-E is defined as percentage of participants meeting HI-E criteria sustained over any consecutive 56-day period over the first 24 weeks.
Measured: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants who Achieved Hematological Improvement-Erythroid (HI-E) for a Minimum 12-Week Period From Day 1 to 48 Weeks
HI-E is defined as percentage of participants meeting HI-E criteria sustained over any consecutive 84-day period over the 48 weeks.
Measured: From Cycle 1 Day 1 through Week 48 (each cycle is 28 days)
Proportion of Participants who are RBC-TI for a Minimum Consecutive 8-Week Period From Day 1 to 24 Weeks
Measured: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants who are RBC-TI for a Minimum Consecutive 24-Week Period From Day 1 to 48 Weeks
Measured: From Cycle 1 Day 1 through Week 48 (each cycle is 28 days)
Time From Date of First Dose to First Onset of Achieving RBC-TI
RBC-TI is defined as the absence of RBC transfusions for a prespecified period of time during continued treatment. Time from date of first dose to first onset of achieving RBC-TI for minimum consecutive 12 weeks and for minimum consecutive 16 weeks.
Measured: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Mean Hgb Change From Baseline Through 24 Weeks and 48 Weeks
Measured: From Baseline through Week 24 and Week 48
Maximum Duration of RBC-TI for Participants who Achieved RBC-TI for a Consecutive ≥12 Weeks and ≥16 Weeks
Measured: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Total Number of Packed Red Blood Cells (pRBC) Units Received During the Study Treatment
Measured: From Cycle 1 Day 1 to End of Treatment (approximately 5 years) (each cycle is 28 days)
Monthly Average of pRBC Units Received During Study Treatment Period
Measured: From Cycle 1 Day 1 to End of Treatment (approximately 5 years) (each cycle is 28 days)
Time From Date of First Dose of Study Drug to Date of First RBC Transfusion Received During Treatment Period
Measured: From Cycle 1 Day 1 to End of Treatment (approximately 5 years) (each cycle is 28 days)
Time From Date of First Dose of Study Drug to First Onset of Achieving HI-E for Minimum Consecutive 8 Weeks Period
Measured: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants with Meaningful Improvement in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Scores
EORTC QLQ-C30 is a 30-item,participant-reported multidomain questionnaire designed to assess the functioning,well-being,and symptom experience of patients with cancer.
Measured: From Cycle 1 Day 1 through Week 24 and 48 (each cycle is 28 days)
Proportion of Participants with Meaningful Improvement in FACT-Anemia (FACT-An) Scale Scores
The FACT-An questionnaire is used to assess the effects of disease symptoms on functioning and well-being in participants with anemia.
Measured: From Cycle 1 Day 1 through Week 24 and 48 (each cycle is 28 days)
Proportion of Participants with Meaningful Improvement in FACIT-Fatigue Scale Scores
The FACT-An Anemia scale includes 13 fatigue-specific items (which together comprise the FACIT-Fatigue scale).
Measured: From Cycle 1 Day 1 through Week 24 and 48 (each cycle is 28 days)
Time to Confirmed Improvement and Time to Confirmed Deterioration in EORTC QLQ-C30 Scale Scores
EORTC QLQ-C30 is a 30-item,participant-reported multidomain questionnaire designed to assess the functioning,well-being,and symptom experience of patients with cancer.
Measured: Baseline through Week 24 and 48
Time to Confirmed Improvement and Time to Confirmed Deterioration in FACT-An Scale Scores
The FACT-An questionnaire is used to assess the effects of disease symptoms on functioning and well-being in participants with anemia.
Measured: Baseline through Week 24 and 48
Time to Confirmed Improvement and Time to Confirmed Deterioration in FACIT-Fatigue Scale Scores
The FACT-An Anemia scale includes 13 fatigue-specific items (which together comprise the FACIT-Fatigue scale).
Measured: Baseline through Week 24 and 48
Average Changes in EORTC QLQ-C 30 Scale Scores Through 48 Weeks
EORTC QLQ-C30 is a 30-item,participant-reported multidomain questionnaire designed to assess the functioning,well-being,and symptom experience of patients with cancer.
Measured: Up to Week 48
Average Changes in FACT-An Scale Scores Through 48 Weeks
The FACT-An questionnaire is used to assess the effects of disease symptoms on functioning and well-being in participants with anemia.
Measured: Up to Week 48
Average Changes in FACIT-Fatigue Scale Scores Through 48 Weeks
The FACT-An Anemia scale includes 13 fatigue-specific items (which together comprise the FACIT-Fatigue scale).
Measured: Up to Week 48
Concentration of Study Drug in Plasma Over Time Data for Participants Treated With Elritercept
Measured: Pre-dose and multiple times post-dose from Cycle 1 Day 1 up to Cycle 13 Day 1 (approximately 49 weeks) (each cycle is 28 days)
Proportion of Participants Treated with Elritercept with Antidrug Antibodies (ADA)
Measured: From Cycle 1 Day 1 to 60 days post last dose (approximately 5 years) (each cycle is 28 days)
Time from Randomization to First Diagnosis of Acute Myeloid Leukemia (AML)
Progression of disease to diagnosis of AML as per world health organisation (WHO) classification of ≥20 percent (%) blasts in peripheral blood or bone.
Measured: From Randomization to Week 48
Time From Randomization to the Death of a Participant From any Cause
Measured: From Randomization to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start21 May 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion1 Oct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422480
- Sponsor's protocol ID
- TAK-226-3001
- Other IDs
- 2025-523544-12-00, jRCT2061250089, 2025
- Acronym
- ELRiSE MDS
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.