Myelodysplastic SyndromesPhase 3NCT06499285
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
A Phase 3 study testing Elritercept in people with Myelodysplastic Syndromes, run by Takeda at 182 sites in 26 countries.
Trial summary
The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Elritercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 182 sitesin 26 countries
- Study dates
- 6 May 2025to 5 Mar 2032
- 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
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information and/or protected personal data in accordance with national and local study participant data protections and privacy regulations.
- Male or female greater than or equal to (≥)18 years of age at the time of signing informed consent.
- Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow sample, read by an independent central reader to confirm diagnosis at Screening) according to the World Health Organization 2016 classification that meets the International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease. In cases where a local bone marrow (BM) assessment establishing an MDS diagnosis was conducted within 12 weeks prior to informed consent form (ICF) signature, the associated local BM samples and/or reports may be permitted.
- Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either:
- LTB, defined as 4 to 7 RBC units per 16 weeks; or b. HTB, defined as ≥8 RBC units per 16 weeks; and c. For all participants: i. Only transfusion events for a pretransfusion hemoglobin (Hgb) lesser than (<)10 grams per deciliter (g/dL) are counted toward eligibility; ii. At least 1 transfusion event in each 8-week period and a minimum of 2 transfusion events separated by ≥7 days within the 16-week period immediately preceding randomization; and iii. No consecutive 56-day period can be RBC transfusion-free during the 16-week period immediately preceding randomization.
- Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to respond to ESA treatment, defined as follows:
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- Refractory to prior ESA treatment: documentation of nonresponse or a response that was no longer maintained with a prior ESA-containing regimen, either as a single agent or combination (e.g., with granulocyte colony-stimulating factor [G-CSF]); ESA regimen must have been either: i. Recombinant human erythropoietin (EPO) ≥30,000 international units per week (IU/week) for ≥8 doses or equivalent; or ii. Darbepoetin alpha ≥500 micrograms (μg) every 3 weeks for ≥3 doses or ≥ 120 μg every week for ≥ 8 doses or equivalent.
- Intolerant to prior ESA treatment: documentation of discontinuation of a prior ESA-containing regimen, either as a single agent or combination (e.g., with G-CSF), at any time after introduction due to intolerance or an AE.
- Unlikely to respond to ESA treatment: low chance of response to ESA based on an endogenous serum EPO level greater than (>)200 units per liter (U/L).
- Less than 5 percent (%) blasts in an evaluable bone marrow sample collected at Screening.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception.
- In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the protocol (e.g., all study procedures, return for follow-up visits).
Who cannot join
- Del(5q) MDS, secondary MDS (MDS with a documented history of prior exposure to chemotherapy, radiotherapy, or other leukemogenic agents that is considered causally related to the development of MDS).
- Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and/or folate).
- Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization.
- 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;
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- Presence of uncontrolled hypertension defined as mean systolic blood pressure ≥160 millimeters of mercury (mm Hg) or diastolic blood pressure ≥100 mm Hg during Screening; or
- 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.
- Child-Pugh class C hepatic impairment.
- Stroke, deep vein thrombosis, or pulmonary embolism within 6 months before Screening.
- Any known history of acute myeloid leukemia (AML).
- Prior history of malignancies, other than MDS, unless participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for ≥ 2 years. However, 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; and/or
- Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis [TNM] clinical staging system).
- Early papillary thyroid cancer (stage I [T1-T2, N0, M0]).
- History of solid organ or bone marrow transplantation.
- Active infection requiring intravenous treatment (e.g., antibiotics, antifungals, or antivirals) within 28 days, or oral treatment within 14 days before randomization.
- Active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Participants with a history of HIV infection may be enrolled if they are receiving antiretroviral therapy and have a documented CD4+ T cell count > 200 cells per microliter (cells/μL) at screening. 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 meter square (kg/m^2).
- Major surgery within 28 days before randomization.
- History of allergy/anaphylaxis to investigational medicinal product (IMP) excipients (refer to the current elritercept IB for a list of excipients) or recombinant proteins.
- Prior use of elritercept, luspatercept, or sotatercept.
- Prior use of hypomethylating agents (HMAs), isocitrate dehydrogenase inhibitor, lenalidomide, imetelstat, or immunosuppressive therapy given for treatment of MDS.
- Iron chelation therapy initiated within 8 weeks before 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 before 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.
- High-dose systemic corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone lesser than or equal to (≤) 10 milligrams per day (mg/day) or corticosteroid equivalent for ≥ 4 weeks are allowed.10 mg/day or corticosteroid equivalent for ≥ 4 weeks are allowed.
- Treatment with any investigational drug within 28 days before Screening or, if the half-life of the product is known, within 5 times the half-life before Screening, whichever is longer.
- Ongoing participation in another interventional clinical study.
- Serum EPO level >500 U/L.
- Platelet count ≥800 × 10^9 per liter (/L) or ≤25 × 10^9/L.
- Absolute neutrophil count ≤ 500 per microliter (/µL).
- Serum aspartate aminotransferase or alanine aminotransferase ≥3 × the upper limit of normal (ULN).
- Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome. 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.
- Ferritin ≤ 50 micrograms per litre (μg/L).
- Folate ≤2.0 nanograms per milliliter (ng/mL).
- Vitamin B12 ≤200 picograms per milliliter (pg/mL).
- Estimated glomerular filtration rate <30 milliliters per minute per 1.73 meter square (mL/min/1.73m^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Collaboration equation.
- Pregnant or lactating female.
- Any other condition not specifically noted above that, in the opinion of the Investigator, would preclude the participant from participating in the study or could confound interpretation of data from the study.
- Investigational site staff members directly involved in the conduct of the study and site staff members otherwise supervised by the Investigator, employees of the Sponsor or CRO directly involved in the conduct of the study, or immediate family members (defined as a spouse, parent, child, or sibling, whether biological or legally adopted).
- For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults (per applicable French law [Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1]).
Trial locations and contacts
182 sites in 26 countries. Contact the study team or a site near you to ask about taking part.
182 sites in 26 countries
United States25 sites, 25 recruiting
- Recruiting
Gabrail Cancer Center Research
Canton, Ohio, 44718
Site Contact, 330-492-3345, research@gabrailcancercenter.com
Nashat Gabrail
- Recruiting
Cleveland Clinic - Cleveland
Cleveland, Ohio, 44195
Site Contact, 216-445-7942, jaina9@ccf.org
Akriti Jain
- Recruiting
Maryland Oncology Hematolofy
Columbia, Maryland, 21044
Site Contact, 410-581-2100, mohit.narang@usoncology.com
Mohit Narang
- Recruiting
Texas Oncology Northeast Texas
Denison, Texas, 75020
Site Contact, 903-868-4700, amir.faridi@texasoncology.com
Amir Faridi
- Recruiting
City of Hope
Duarte, California, 91010
Site Contact, 626-218-2404, aartz@coh.org
Andrew Artz
- Recruiting
Los Angeles Cancer Network
Glendale, California, 91206
Site Contact, 215-707-7312, eric.lee@lahomg.com
Eric Lee
- Recruiting
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89169
Site Contact, 702-952-3444, edwin.kingsley@usoncology.com
Edwin Kingsley
- Recruiting
U.T. MD Anderson Cancer Center, Division of Cancer Medicine
Houston, Texas, 77030
Site Contact, 713-792-6161, ggarciam@mdanderson.org
Guillermo Garcia-Manero
- Recruiting
LUMI Research
Houston, Texas, 77090
Site Contact, dmnguyen@lumiresearch.com
David Nguyen
- Not yet recruiting
Epic Care Emeryville
Issaquah, Washington, 98029
Site Contact, behlr@sutterhealth.org
Rajesh Behl
- Recruiting
MidAmerica Cancer Care
Kansas City, Missouri, 64132
Site Contact, 816-974-5050, benjamin.fangman@aoncology.com
Benjamin Fangman
- Recruiting
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909
Site Contact, 865-934-5800, tracy.dobbs@tncancer.com
Tracy Dobbs
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92037
Site Contact, 858-822-6100, amanda.kagan@jhmi.edu
Amanda Kagan
- Recruiting
Norton Cancer Institute
Louisville, Kentucky, 40207
Site Contact, 502-906-7543, Don.Stevens@nortonhealthcare.org
Don Stevens
- Recruiting
University of Miami Hospital and Clinics
Miami, Florida, 33136
Site Contact, 305-243-9974, msekeres@med.miami.edu
Mikkael Sekeres
- Not yet recruiting
Ghattas Oncology
Monroe, Louisiana, 71201
Site Contact, tghattas@epicmedresearch.com
Tharwat Ghattas
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Site Contact, 615-322-5000, Ashwin.Kishtagari@vumc.org
Ashwin Kishtagari
- Recruiting
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06511
Site Contact, 203-737-7103, amer.zeidan@yale.edu
Amer Zeidan
- Recruiting
ILCC. Illinois Cancer Centers
Peoria, Illinois, 61645
Site Contact, 309-240-6388, paul.fishkin@usoncology.com
Paul Fishkin
- Not yet recruiting
Epic Medical Research
Red Oak, Texas, 75154
Site Contact, kkoticha@epicmedresearch.com
Kirtan Koticha
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Site Contact, 888-860-2778, rami.komrokji@moffitt.org
Rami Komrokji
- Recruiting
Texas Oncology Gulf Coast
The Woodlands, Texas, 77380
Site Contact, 409-938-8600, andrew.jackson@usoncology.com
Andrew Jackson
- Recruiting
Tranquil Research
Webster, Texas, 77598-4085
Site Contact, 713-907-6054, drknecht@cls.health
John Knecht
- Recruiting
Clinical Research Alliance NY
Westbury, New York, 11590
Site Contact, 516-488-2918, jgoldberg@caremount.com
Jonathan Goldberg
- Recruiting
Novant Health-Cancer Institute
Winston-Salem, North Carolina, 27013
Site Contact, 336-718-5570, jpdugan@novanthealth.org
James Dugan
United Kingdom14 sites, 14 recruiting
- Recruiting
Aberdeen Royal Infirmary
Aberdeen, Aberdeen City, AB25 2ZN
Site Contact, dominic.culligan@nhs.scot
Dominic Culligan
- Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2TH
Site Contact, 44-121-627-2000, Vidhya.Murthy2@uhb.nhs.uk
Vidhya Murthy
- Recruiting
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Site Contact, 44-1223-805000, duncanbrian@nhs.net
Duncan Brian
- Not yet recruiting
The Newcastle Upon Tyne University Hospitals Foundation Trust
High Heaton, Tyne and Wear, NE7 7DN
Site Contact, michelle.lannon@nhs.net
Michelle Lannon
- Recruiting
St James's University Hospital
Leeds, LS9 7TF
Site Contact, 44-113-243-3144, catherine.cargo@nhs.net
Catherine Cargo
- Recruiting
University Hospitals of Leicester
Leicester, Leics, LE1 5WW
Site Contact, matthew.lee3@nhs.net
Matthew Lee
- Recruiting
Lincolnshire Community and Hospitals NHS group
Lincoln, Lincolnshire, LN2 5QY
Site Contact, crinaldi@nhs.net
Ciro Rinaldi
- Recruiting
King's College Hospital
London, SE5 9RS
Site Contact, +44 (79) 6768 6823, austin.kulasekararaj@nhs.net
Austin Kulasekararaj
- Recruiting
Sarah Cannon Research Institute (SCRI)
London, W1G 6AD
Site Contact, 615-329-7274, jenniferosullivan@nhs.net
Jennifer O'Sullivan (Dillon)
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Site Contact, 44-161-446-3000, daniel.wiseman@nhs.net
Daniel Wiseman
- Recruiting
Nottingham City Hospital
Nottingham, NG5 1PB
Site Contact, 44-115-969-1169, Jennifer.Byrne@nuh.nhs.uk
Jennifer Byrne
- Recruiting
Churchill Hospital
Oxford, OX3 7LE
Site Contact, 44-300-304-7777, Oni.Chowdhury@ouh.nhs.uk
Oni Chowdhury
- Recruiting
Glan Clwyd Hospital
Rhyl, Denbighshire, LL18 5UJ
Site Contact, earnest.heartin@wales.nhs.uk
Earnest Heartin
- Not yet recruiting
South Tyneside and Sunderland Foundation Trust
Sunderland, Tyne and Wear, SR4 7TP
Site Contact, scott.marshall3@nhs.net
Scott Marshall
Brazil12 sites, 12 recruiting
- Recruiting
Hosptial Erasto Gaertner
Curitiba, Paraná, 81520-060
Site Contact, drciliao@gmail.com
Eduardo Munhoz
- Recruiting
FundaAAo Doutor Amaral Carvalho
Jaú, São Paulo, 17210-080
Site Contact, pesquisafac.edersonmattos@gmail.com
Guilherme Mattos
- Recruiting
Instituto Joinvilense de Hematologia e Oncologia
Joinville, Santa Catarina, 89201-260
Site Contact, marcelolacerda001@gmail.com
Lacerda Marcelo
- Recruiting
Porto Alegre Clinical Hospital (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-903
Site Contact, 55-51-3359-8000, fogliattopesquisa@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) 33789927, marcelocapra@hotmail.com
Marcelo Capra
- Recruiting
Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
Porto Alegre, Rio Grande do Sul, 90610-000
Site Contact, 55-51-3320-3660, mzschaan@hotmail.com
Mariza Schaan
- Recruiting
Americas Institute
Rio de Janeiro, 22775-001
Site Contact, 21-3385-2000, fernandomonteiro@americasoncologia.com.br
Fernando Correia Pinto
- Recruiting
Cepho- Fmabc
Santo André, São Paulo, 09060-650
Site Contact, vitormauad.medabc@gmail.com
Vitor Mauad
- Recruiting
Sao Jose do Rio Preto Regional Faculty of Medicine Foundation
São José do Rio Preto, São Paulo, 15090-000
Site Contact, 55-17-3201-5000, marianabuka@outlook.com
Mariana Buka
- Recruiting
Portuguese Charity of Sao Paulo, Clinical Hematology / Oncology Center
São Paulo, 01323-900
Site Contact, +55 (11) 3505 6615, scheinbp@gmail.com
Phillip Scheinberg
- Recruiting
Hospital A.C.Camargo ("Antonio Prudente" Foundation)
São Paulo, 01509-900
Site Contact, 55-11-9-9901-3833, marina.nascimento@accamargo.org.br
Marina Nascimento
- Recruiting
Santa Casa of Mercy of Santos
São Paulo, 11075-900
Site Contact, 13-3221-5508, elaine_mancilha@hotmail.com
Elaine Mancilha
India12 sites, 12 recruiting
- Recruiting
Heamto Oncology Clinic Ahmedabad Pvt. Ltd.
Ahmedabad, Gujarat, 380009
Site Contact, 9824041170, sandip60@yahoo.com
Sandip Shah
- Recruiting
Apollo Hospital International Ltd
Ahmedabad, Gujarat, 382428
Site Contact, 9920273063, profvelunair@gmail.com
Velu Nair
- Not yet recruiting
Rajiv Gandhi Cancer Institute & Research Centre
Delhi, 110085
Site Contact, 9971500861, Bhurani@gmail.com
Dinesh Bhurani
- Not yet recruiting
Amrita Institute of Medical Sciences
Ernākulam, Kerala, 682041
Site Contact, 9946047464, neerajsidharthan@aims.amrita.edu
Neeraj Siddharthan
- Not yet recruiting
Max Super Speciality Hospital Vaishali (A Unit Of Crosslay Remedies Ltd.)
Ghaziabad, Uttar Pradesh, 201012
Site Contact, 9451405842, pradeep.kumar9@maxhealthcare.com
Pradeep Kumar
- Recruiting
Medanta the Medicity
Gūrgaon, 122018
Site Contact, 9717265111, nitin.sood@medanta.org
Nitin Sood
- Recruiting
NRS Medical College and Hospital
Kolkata, West Bengal, 700014
Site Contact, 9874890275, tkdolai@hotmail.com
Tuphan Kanti Dolai
- Recruiting
Tata Medical Center, Kolkata
Kolkata, West Bengal, 700156
Site Contact, 3366057620, arijit.nag@tmckolkata.com
Arijit Nag
- Recruiting
Christian Medical College, Ludhianana
Ludhiana, Punjab, 380006
Site Contact, 8054959525, mjosephjohn@gmail.com
Joseph John
- Not yet recruiting
Tata Memorial Centre
Mumbai, Maharashtra, 400012
Site Contact, 9632006180, dralokshetty@gmail.com
Alok Shetty
- Recruiting
All India Institute of Medical Science
New Delhi, National Capital Territory of Delhi, 110029
Site Contact, 911126588499, drtulikaseth@gmail.com
Tulika Seth
- Recruiting
Christian Medical College
Vellore, Tamil Nadu, 632004
Site Contact, 4172224553, biju@cmcvellore.ac.in
Biju George
Australia9 sites, 9 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Site Contact, +61 (8) 8222 3369, Devendra.hiwase@sa.gov.au
Devendra Hiwase
- Recruiting
Flinders Medical Centre
Adelaide, South Australia, 5042
Site Contact, +61 (8) 8222 4000, Ashanka.Beligaswatte@sa.gov.au
Ashanka Beligaswatte
- Recruiting
Box Hill Hospital
Box Hill, Victoria, 3128
Site Contact, +61 (3) 8396 8442, genevieve.douglas@easternhealth.org.au
Genevieve Douglas
- Recruiting
Townsville University Hospital
Douglas, Queensland, 4814
Site Contact, 61-7-4433-1111, Joel.Wight@health.qld.gov.au
Joel Wight
- Recruiting
St Vincent's Hospital (Melbourne) Ltd
Fitzroy, Victoria, 3065
Site Contact, 61-3-9231-2211, ShuhYing.TAN@svha.org.au
ShuhYing Tan
- Not yet recruiting
The Canberra Hospital
Garran, Australian Capital Territory, 2605
Site Contact, phil.choi@act.gov.au
Philip Choi
- Not yet recruiting
Alfred Health
Melbourne, Victoria, 3004
Site Contact, shaun.fleming1@monash.edu
Shaun Fleming
- Recruiting
Peter MacCallum Cancer Center
Parkville, Victoria, 3000
Site Contact, +61 (0) 3 8559 5000, Lynette.Chee@mh.org.au
Lynette Chee
- Recruiting
Westmead Hospital
Sydney, New South Wales, 2145
Site Contact, +61 () 424275524, lachlin.vaughan@health.nsw.gov.au
Lachlin Vaughan
Italy9 sites, 9 recruiting
- Recruiting
Aou Delle Marche
Ancona, AN, 60126
Site Contact, a.poloni@staff.univpm.it
Antonella Poloni
- Recruiting
Careggi University Hospital
Florence, 50134
Site Contact, +39 (55) 794 7296, valeria.santini@unifi.it
Valeria Santini
- Recruiting
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
Milan, 20122
Site Contact, 02-5503-4422, bruno.fattizzo@policlinico.mi.it
Bruno Fattizzo
- Recruiting
Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology
Pavia, 27100
Site Contact, +39 (382) 503 062, luca.malcovati@unipv.it
Luca Malcovati
- Recruiting
Granda Ospedale Metropolitano 'Bianchi-Melacrino-Morelli'
Reggio Calabria, 89133
Site Contact, caterina.alati@gmail.com
Caterina Alati
- Recruiting
Foundation PTV - Polyclinic Tor Vergata
Rome, 00133
Site Contact, +39 (6) 2090 3210, mtvoso@rm.unicatt.it
Maria Teresa Voso
- Recruiting
Clinical Institute Humanitas, IRCCS
Rozzano, 20089
Site Contact, 39-02-82241, matteo.della_porta@hunimed.eu
Matteo Giovanni Della Porta
- Not yet recruiting
AO Ordine Mauriziano
Turin, Piedmont, 10128
Site Contact, daniela.cilloni@unito.it
Daniela Cilloni
- Recruiting
Institute of Cancer Research and Treatment of Candiolo
Turin, 10060
Site Contact, 39-011-993-3111, elena.crisa@ircc.it
Elena Crisa
Germany7 sites, 7 recruiting
- Recruiting
Praxis am Volkspark Berlin
Berlin, 10715
Site Contact, 49-30-84723535, jp.habbel@praxis-am-volkspark-berlin.de
Jan-Piet Habbel
- Recruiting
Charite Universitatsmedizin Berlin
Berlin, 12203
Site Contact, +49 (30) 450 513 535, kathrin.rieger@charite.de
Kathrin Rieger
- Not yet recruiting
University Hospital Bronn
Bonn, North Rhine-Westphalia, 53127
Site Contact, 49-228-2870, karin.mayer@ukb.uni-bonn.de
Karin Mayer
- Recruiting
Marien Hospital Duesseldorf GmbH, Clinic for Oncology, Hematology and Palliative Medicine
Düsseldorf, North Rhine-Westphalia, 40479
Site Contact, +49 (211) 4400 2501, Aristoteles.giagounidis@vkkd-kliniken.de
Aristoteles Giagounidis
- Recruiting
University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
Halle, Saxony-Anhalt, 06120
Site Contact, +49 (345) 557 3080, haifa.al-ali@uk-halle.de
Haifa Al-Ali
- Recruiting
University Hospital Leipzig, Clinic and Policlinic for Internal Medicine I Haematology and Stem Cell Therapy, Medical Oncology, Haemostaseology
Leipzig, Saxony, 04103
Site Contact, 49-341-9713081, Dominic.Brauer@medizin.uni-leipzig.de
Dominic Brauer
- Not yet recruiting
University Clinic of Hematology, Oncology and Cell Therapy
Magdeburg, Saxony-Anhalt, 39120
Site Contact, 646-501-0194, mirjeta.berisha@med.ovgu.de
Berisha Mirjeta
Turkey (Türkiye)7 sites, 7 recruiting
- Recruiting
Adana City Hospital
Adana, 01370
Site Contact, +90 (542) 630 8353, elifsuyani@hotmail.com
Elif Suyani
- Not yet recruiting
Ankara Etlik City Hospital
Ankara, 06170
Site Contact, 90-362-312-1919, merihkizil@yahoo.com
Merih Kizil Cakar
- Not yet recruiting
Ankara University Medical Faculty Cebeci Hospital
Ankara, 06600
Site Contact, 90-312-595-6000, sktoprak@yahoo.com
Selami Toprak
- Recruiting
Antalya Education and Training Hospital
Antalya, 07100
Site Contact, +90 (505) 765 6778, dr_v_karakus@yahoo.com
Volkan Karakus
- Not yet recruiting
Mersin Medicalpark Hospital
Mersin, 33200
Site Contact, +90 (532) 346 0767, aniltombak@hotmail.com
Anil Tombak
- Recruiting
Sakarya University Medical Faculty Hospital
Sakarya, 54290
Site Contact, 90-4445400, SunuCenk@gmail.com
Cenk Sunu
- Recruiting
Ondokuz Mayis University School of Medicine, Department of Hematology
Samsun, 55139
Site Contact, +90 (505) 272 2289, engink@omu.edu.tr
Engin Kelkitli
Canada6 sites, 6 recruiting
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Site Contact, +1 (780) 407 1584, yannancy@ualberta.ca
Nancy Zhu
- Recruiting
Nova Scotia Health Authority, Centre for Clinical Research
Halifax, Nova Scotia, B3H 1V7
Site Contact, +1 (902) 473 3498, amy2.trottier@nshealth.ca
Amy Trottier
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 4L6
Site Contact, 519-685-8380, Lalit.Saini@lhsc.on.ca
Lalit Saini
- Recruiting
Sunnybrook Research Institute, Odette Cancer Center
Toronto, Ontario, M4N 3M5
Site Contact, +416 (480) 5847, Rena.Buckstein@sunnybrook.ca
Rena Buckstein
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Site Contact, +1 (416) 946 4501, Karen.Yee@uhn.ca
Karen Yee
- Recruiting
Providence Hematology - Vancouver
Vancouver, British Columbia, V6Z 2A5
Site Contact, +1 (604) 684 5794, hleitch@pacifichematology.ca
Heather Leitch
Czechia6 sites, 6 recruiting
- Not yet recruiting
University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
Brno, 625 00
Site Contact, + (420) 532 231 111, Mayer.Jiri@fnbrno.cz
Jiri Mayer
- Recruiting
University Hospital Hradec Kralove, 4th Internal Clinic of Hematology
Hradec Králové, 500 05
Site Contact, + (420) 495 833 837, petra.belohlavkova@fnhk.cz
Petra Belohlavkova
- Recruiting
Charles University General Hospital
Ostrava, 70852
Site Contact, anna.jonasova@vfn.cz
Anna Jonasova
- Recruiting
University Hospital Ostrava and Faculty of Medicine, University of Ostrava
Ostrava, 70852
Site Contact, barbora.dluhosova@fno.cz
Zdenek Koristek
- Recruiting
University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
Prague, 100 00
Site Contact, + (420) 267 162 887, olga.cerna@fnkv.cz
Olga Cerna
- Not yet recruiting
Institute of Hematology and Blood Transfusion, Division of Training and Development
Prague, 12800
Site Contact, 420-221-977-296, marketa.markova@uhkt.cz
Marketa Stastna-Markova
Ireland6 sites, 6 recruiting
- Recruiting
Cork University Hospital
Cork, T12 DC4A
Site Contact, 353-21-492-2000, Vitaliy.mykytiv@hse.ie
Vitaliy Mykytiv
- Recruiting
Beaumont Hospital
Dublin, D05 DK31
Site Contact, +353 (1) 809 2373, philipmurphy@beaumont.ie
Philip Murphy
- Recruiting
Mater Misericordiae University Hospital
Dublin, D07 R2WY
Site Contact, 353-1-803-2000, SuMaung@mater.ie
Su Maung
- Recruiting
Tallaght University Hospital
Dublin, D24 NR0A
Site Contact, 353-1-221-4000, Helen.Enright@tuh.ie
Helen Enright
- Recruiting
St Vincent's University Hospital (SVUH)
Dublin, DO4 T6F4
Site Contact, 353-1-221-4000, claireandrews@st-vincents.ie
Claire Andrews
- Not yet recruiting
University Hospital Limerick
Limerick, V94 F858
Site Contact, +353 (877) 385 852, cian.mcellistrim@hse.ie
Cian McEllistrim
South Korea6 sites, 6 recruiting
- Recruiting
Kyungpook National University Hospital
Daegu, 41944
Site Contact, +82 (53) 200 5570, jhmoon74@knuh.kr
Joon ho Moon
- Recruiting
Seoul National University Hospital
Seoul, 03080
Site Contact, +82 (2) 2072-0834, hongjblood@snu.ac.kr
Junshik Hong
- Recruiting
Soon Chun Hyang University Hospital Seoul
Seoul, 04401
Site Contact, 82-2-709-9144, ysy6496@schmc.ac.kr
Seug Yun Yoon
- Recruiting
Asan Medical Center
Seoul, 05505
Site Contact, +82 (2) 3010 3218, jhlee3@amc.seoul.kr
Je-Hwan Lee
- Recruiting
Samsung Medical Center
Seoul, 06351
Site Contact, +82 (2) 3410 0918, smcjunhojang@gmail.com
Jun Ho Jang
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Site Contact, 82-1588-1511, yoojink@catholic.ac.kr
Yoo Jin Kim
Spain6 sites, 6 recruiting
- Recruiting
University Hospital Vall d'Hebron, Department of Hematology
Barcelona, Catalonia, 08035
Site Contact, +34 (932) 746 100, dvalcarcel@vhio.net
David Valcarcel Ferreiras
- Recruiting
Catalan Institute of Oncology, Hospital Duran i Reynals, Department of Clinical Hematology
L'Hospitalet de Llobregat, Girona, 08908
Site Contact, +34 (932) 607 750, marnan@iconcologia.net
Montserrat Arnan Sangerman
- Recruiting
University Hospital Ramon y Cajal
Madrid, Madrid, 28034
Site Contact, 34-913-36-8000, kyra.vkennedy@gmail.com
Kyra Velazquez Kennedy
- Recruiting
University Hospital Foundation Jimenez Diaz
Madrid, Madrid, 28040
Site Contact, 34-915-50-4800, tarquero@fjd.es
Teresa Arquero Portero
- Recruiting
University Clinical Hospital of Salamanca, Department of Hematology
Salamanca, Castille and León, 37007
Site Contact, +34 (923) 291 100, mdiezcampelo@usal.es
Maria Diez Campelo
- Recruiting
University and Polytechnic Hospital La Fe
Valencia, Valencia, 46026
Site Contact, 34-961-24-4000, mora_elv@gva.es
Elvira Mora Castera
Taiwan6 sites, 6 recruiting
- Recruiting
Changhua Christian Hospital
Changhua, Changhua County, 500209
Site Contact, 886-4-723-8595, 155627@cch.org.tw
Ruo-Han Tseng
- Recruiting
Chang Bing Show Chwan Memorial Hospital
Changhua, Changhua County, 50544
Site Contact, 886-4-781-3888, cs4816@gmail.com
Cheng-Shyong Chang
- Recruiting
Taichung Veterans General Hospital
Taichung, 407219
Site Contact, 886-4-2359-2525, briefsummer@gmail.com
Cheng-Hsien Lin
- Recruiting
National Cheng Kung University Hospital
Tainan, 704302
Site Contact, +886 (6) 235 3535, teresa@mail.ncku.edu.tw
Tsai-Yun Chen
- Recruiting
National Taiwan University Hospital
Taipei, 100225
Site Contact, 886-2-2312-3456, wchou@ntu.edu.tw
Wen-Chien Chou
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan City, 333
Site Contact, 886-3-328-1200, kmc12069@gmail.com
Ming-Chung Kuo
Bulgaria5 sites, 5 recruiting
- Recruiting
Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD)
Plovdiv, 4002
Site Contact, +359 (32) 602 298, penchogeorgiev@yahoo.com
Pencho Georgiev
- Recruiting
University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology
Sofia, 1431
Site Contact, 359-52-978-288, aradinoff@hotmail.com
Atanas Radinoff
- Recruiting
Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical Academy, Clinic of Hematology
Sofia, 1606
Site Contact, +359 (884) 674 160, viktoriia1982@abv.bg
Viktoria Barbukova
- Recruiting
Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology
Sofia, 1797
Site Contact, +359 (898) 719 792, drtanyayankova@gmail.com
Tanya Yankova
- Not yet recruiting
University Multiprofile Hospital for Active Treatment "Sveta Marina", Clinic of Clinical Hematology
Varna, 9010
Site Contact, +359 (52) 978 288, IlinaMichevailinamicheva@gmail.com
Ilina Micheva
Chile5 sites, 5 recruiting
- Recruiting
Dr. Guillermo Grant Benavente - Concepcion Regional Hospital
Concepción, Biobio, 4070356
Site Contact, 56-41-272-2500, mpromero@hospitalinfantildesanjose.org.co
Monica Romero
- Recruiting
IC La Serena Research
La Serena, Coquimbo Region, 1720430
Site Contact, 56-51-286127, cleiden.villegas@iclsr.cl
Cleiden Villegas
- Recruiting
SAGA Clinical Research Center SpA
Santiago, 7500653
Site Contact, 56-9-8326-9755, ahernandez@cecsaga.cl
Ada Hernandez
- Recruiting
Clinic Inmunocel
Santiago, 7580206
Site Contact, jvinuela@inmunocel.com
Jose Vinuela
- Recruiting
Center for Clinical Studies and Medical Research (CECIM)
Santiago, 8320000
Site Contact, 56-9-5826-3308, alexander.arellano@cecim.cl
Alexander Arellano
Hungary5 sites, 5 recruiting
- Recruiting
Semmelweis University, Department of Internal Medicine and Haematology, Division of Hematology
Budapest, H-1088
Site Contact, +36 (20) 825 8660, nagy.zsolt@med.semmelweis-univ.hu
Zsolt Nagy
- Recruiting
University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology
Debrecen, 4032
Site Contact, +36 (52) 255 480, illesarpaddr@gmail.com
Arpad Illes
- Recruiting
Mor Kaposi General Hospital, Department of Hematology
Kaposvár, H-7400
Site Contact, +36 (82) 501 363, dregyedmiklos@yahoo.com
Miklos Egyed
- Recruiting
Szabolcs-Szatmar-Bereg County Teaching Hospital, Department of Hematology
Nyíregyháza, 4400
Site Contact, +36 (42) 599 719, lrejto@med.unideb.hu
Laszlo Rejto
- Recruiting
Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine III, Hematology
Székesfehérvár, H-8000
Site Contact, +36 (20) 970 9318, aszomor@clinics.pote.hu
Arpad Szomor
Peru5 sites, 5 recruiting
- Not yet recruiting
Daniel Alcides Carrion National Hospital
Bellavista, 07016
Site Contact, 997-889-111, joserevi7@yahoo.com
Jose Chinen Pemberton
- Not yet recruiting
Edgardo Rebagliati Martins National Hospital
Lima, Jesus Maria, 15073
Site Contact, +51 (987) 245-661, lourdesaranda@gmail.com
Lourdes Aranda
- Recruiting
Anglo American Clinic
Lima, La Molina, 15023
Site Contact, 51-1-6168900, antonio1carrasco@hotmail.com
Antonio Carrasco
- Recruiting
IPOR: Peruvian Institute of Oncology & Radiotherapy
Lima, San Isidro Lima, 02002
Site Contact, 51-1-2241779, maria.vera.vasquez1@gmail.com
Maria Vera Vasquez
- Not yet recruiting
National Institute of Neoplastic Diseases
Lima, 15038
Site Contact, +51 (942) 136-304, jufravas1ro@hotmail.com
Jule Vasquez
Poland5 sites, 5 recruiting
- Recruiting
Pratia Oncology Katowice
Katowice, 40-519
Site Contact, 48-501-714-019, sebastian.grosicki@pratia.com
Sebastian Grosicki
- Recruiting
Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz, General Hematology Unit
Lodz, 93-513
Site Contact, +48 (42) 689 5191, robaktad@csk.umed.lodz.pl
Tadeusz Robak
- Recruiting
Clinical Hospital Of The Ministry Of Internal Affairs And Administration With Warmia And Mazury Oncology Centre In Olsztyn, Clinical Department of Hematology and Internal Medicine with Bone Marrow Transplantation Center
Olsztyn, 10-228
Site Contact, + (48) 602 120 684, janusz.halka@poliklinika.net
Janusz Halka
- Recruiting
Pratia Poznan
Poznan, Greater, 60-192
Site Contact, anna.hoppe@pratia.com
Anna Hoppe
- Recruiting
Pratia Onkologia Wroclaw
Wroclaw, Lower Silesian Voivodeship, 50-019
Site Contact, rybka.justyna@o2.pl
Justyna Rybka
Thailand5 sites, 5 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Site Contact, +66 (2) 251 6704, drnoppacharn@yahoo.com
Noppacharn Uaprasert
- Recruiting
Rajavithi Hospital
Bangkok, 10400
Site Contact, +66 (2) 206 2900, kunapa@gmail.com
Kunapa Iam-arunthai
- Recruiting
Ramathibodi Hospital
Bangkok, 10400
Site Contact, +66 (2) 201 2373, Nickero059@hotmail.com
Piyajaroenkij Thanakrit
- Recruiting
Banphaeo General Hospital
Bangkok, 74210
Site Contact, 034-419555-6, Himatologist55@gmail.com
Busakorn Sae-Aeng
- Recruiting
Maharaj Nakorn Chiangmai Hospital
Chiang Mai, 50200
Site Contact, +66 (53) 945 482, thanawat_r@outlook.com
Thanawat Rattanathammethee
France4 sites, 4 recruiting
- Recruiting
Archet 1 and 2 hospital
Nice, 06200
Site Contact, +33 (4) 9203 7777, cluzeau.t@chu-nice.fr
Thomas Cluzeau
- Recruiting
Saint-Louis Hospital
Paris, 75010
Site Contact, +33 (1) 7120 7021, lionel.ades@aphp.fr
Lionel Ades
- Recruiting
Poitiers University Hospital Center - Miletrie Site
Poitiers, 86000
Site Contact, +33 (5) 4944 5415, Jose-Miguel.Torregrosa-Diaz@chu-poitiers.fr
Jose Miguel Torregrosa-Diaz
- Recruiting
IUCT-Oncopole
Toulouse, 31059
Site Contact, +33 (531) 156 266, Comont.Thibault@iuct-oncopole.fr
Thibault Comont
Israel4 sites, 4 recruiting
- Recruiting
Hadassah Medical Center, Department of Hematology
Jerusalem, 9112001
Site Contact, +972 (2) 677 6748, sabanre@hadassah.org.il
Revital Saban
- Recruiting
Rabin Medical Center, Davidoff Cancer Center, Hemato-Oncology Institute
Petah Tikva, 49100
Site Contact, +972 (3) 937 8116, owolach@gmail.com
Ofir Wolach
- Recruiting
Chaim Sheba Medical Center, Department of Hematology, Myelodysplastic Syndromes Center
Ramat Gan, 5266202
Site Contact, +972 (3) 530 5213, Drorit.Merkel@sheba.health.gov.il
Drorit Merkel
- Recruiting
The Tel Aviv Sourasky Medical Center, Department of Hematology and Bone Marrow Transplantation, Leukemia Service
Tel Aviv, 6423906
Site Contact, 972-3-697-4444, yakirm@tlvmc.gov.il
Yakir Moshe
South Africa4 sites, 4 recruiting
- Recruiting
Haemalife
Cape Town, 7580
Site Contact, +27 (21) 581 0717, michael.cass@haemalife.co.za
Michael Cass
- Recruiting
Capital Haematology Hospital
Durban, 4091
Site Contact, 27-31-832-9700, jaimendra.singh@gmail.com
Jaimendra Singh
- Recruiting
Charlotte Maxeke Johannesburg Academic Hospital, Hemophilia Comprehensive Care Center
Johannesburg, 2193
Site Contact, +27 (11) 489 8413, johnny.mahlangu@nhls.ac.za
Johnny Mahlangu
- Recruiting
Alberts Cellular Therapy
Pretoria, 0181
Site Contact, +27 (12) 993 2555, andrew@actlife.co.za
Andrew McDonald
Sweden4 sites, 4 recruiting
- Not yet recruiting
Sahlgrenska University Hospital
Gothenburg, VG, 41345
Site Contact, lena.von.bahr@vgregion.se
Lena Von Bahr
- Recruiting
Karolinska University Hospital
Huddinge, Stockholm County, 141 57
Site Contact, 46-8-123-700000, magnus.tobiasson@ki.se
Magnus Tobiasson
- Recruiting
Skane University Hospital - Lund, Department of Hematology and Vascular Disorders
Lund, 221 85
Site Contact, +46 (46) 171 000, lars.nilsson@skane.se
Lars Nilsson
- Not yet recruiting
A-rebro University Hospital, Hematology Department
Örebro, A-rebro County, 70185
Site Contact, bengt.rasmussen@regionorebrolan.se
Bengt Rasmussen
Switzerland3 sites, 3 recruiting
- Not yet recruiting
University Hosptial Basel
Basel, Canton of Basel-City, 4031
Site Contact, gregor.stehle@usb.ch
Gregor Stehle
- Not yet recruiting
Insel Gruppe AG, University Clinic for Hematology and Central Hematological Laboratory
Bern, 3010
Site Contact, natalia.baran@insel.ch
Natalia Baran
- Recruiting
Universitatsspital Zurich, Klinik fur Medizinische Onkologie und Hamatologie
Zurich, 8091
Site Contact, stefan.balabanov@usz.ch
Stefan Balabanov
Lithuania2 sites, 2 recruiting
- Recruiting
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, LT-50161
Site Contact, +370 (614) 84 658, milda.rudzianskiene@gmail.com
Milda Rudzianskiene
- Recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius, LT-08406
Site Contact, 370-5-250-1717, andrius.degulys@santa.lt
Andrius Degulys
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants With Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)
The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.
Read the detailed description
This is a Phase 3, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of elritercept (TAK-226, KER-050) versus placebo. Elritercept (TAK-226, KER-050) is an investigational medicinal product being developed for the treatment of anemia in adult participants with a diagnosis of lower-risk myelodysplastic neoplasms/syndromes. After all required Screening Period assessments are completed, and eligibility is confirmed, participants will be randomized and enter the Primary Phase of the Double-Blind Treatment Period. Participants will be randomly assigned in a 2:1 ratio to receive either elritercept (TAK-226, KER-050) or placebo subcutaneously (SC) every 4 weeks (Q4W). Participants will be stratified according to their ring sideroblasts (RS) status (RS-positive versus non-RS) and baseline transfusion burden (low-transfusion burden [LTB] versus high transfusion burden [HTB]). The Primary Phase of the Double-blind Treatment Period will last 24 weeks. The Secondary Phase of the Double-Blind Treatment Period will last an additional 24 weeks. During the Secondary Phase of the Double-Blind Treatment Period, all participants will continue to receive the same double-blind treatment they received during the Primary Phase. Study visits will occur approximately every 2 weeks from Cycle 1 through Cycle 6 and every 4 weeks from Cycle 7 through the remainder of the Double-Blind Treatment Period. During the Extension Phase of the Double-Blind Treatment Period, all eligible participants will continue to receive the same double-blind treatment they received during the Primary and Secondary Phases. Participants will continue in the Extension Phase until they individually discontinue or until the study is unblinded. For participants to remain on double-blind treatment, they must meet the criteria outlined in the MDS disease assessment criteria every 24 weeks. Based on the outcome of the Week 24 MDS disease assessment, participants will either continue in the Extension Phase of the Double-blind Treatment Period or will be discontinued from treatment and proceed to End of Treatment and then into the Safety Follow-up Period. The Safety Follow-Up Period will extend from the last dose of study treatment through 8 weeks after the last dose of study treatment. Study visits should occur every 4 weeks within the Safety Follow-Up Period. Long-term follow-up will take place quarterly after a participant has completed the Safety Follow-Up Period. Long-term follow-up will continue for 5 years from the first dose of study treatment, or until a participant is deceased, is lost to follow-up, withdraws consent, or the study closes, whichever is earliest.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Elritercept, Placebo
- Keywords
- Anemia, Elritercept, Myelodysplastic neoplasms, KER-050, MDS
- 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 KER-050, TAK-226
Elritercept (TAK-226, KER-050) administered subcutaneously every 4 weeks.
PlaceboDrug
Elritercept (TAK-226, KER-050) matching-placebo administered subcutaneously every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Elritercept | Experimental | Participants will be administered elritercept (TAK-226, KER-050), subcutaneously every 4 weeks, up to 48 weeks or until the end of treatment period. Receives: Drug: Elritercept |
| Placebo | Placebo comparator | Participants will be administered elritercept (TAK-226, KER-050) matching-placebo, subcutaneously every 4 weeks, up to 48 weeks or until the end of treatment period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Transfusion Independence (TI) for ≥8 Weeks
Transfusion independence is defined as the absence of any red blood cells (RBC) transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24.
Measured: Baseline through Week 24
Secondary outcomes (4)
Percentage of Participants Achieving TI for ≥24 Weeks
Transfusion independence is defined as the absence of any RBC transfusions in a period of at least 24 weeks after the first dose of the study treatment through week 48.
Measured: Baseline through Week 48
Percentage of Participants with High-transfusion Burden (HTB) Achieving TI for ≥8 weeks
Transfusion independence is defined as the absence of any RBC transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24.
Measured: Baseline through Week 24
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is defined as any untoward medical occurrence, in a clinical study participant administered a medicinal product, that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not it is related to study treatment. A TEAE is defined as an AE that commences on or after the first dose of the study treatment and within 60 days after the last dose of the study treatment, or analysis cutoff date, whichever is earlier. An SAE is any untoward medical occurrence that, at any dose: results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.
Measured: From the time of signing the informed consent form through 60 days after the last dose of study treatment, approximately 6 years
Change from Baseline in Clinical Laboratory Values, Vital Signs, and Electrocardiograms (ECGs)
Change from baseline in clinical laboratory values, vital signs, and ECGs will be assessed.
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start6 May 2025
- Primary completion15 Sep 2028 (estimated)
- Study completion5 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies 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
- Model description
- Participants will be randomly assigned in a 2:1 ratio to receive either elritercept (TAK-226, KER-050) or placebo, respectively, subcutaneously every 4 weeks. Randomization will be stratified according to ring sideroblast status and baseline transfusion burden.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 225 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
- NCT06499285
- Sponsor's protocol ID
- KER-050-D301
- Other IDs
- 2024-516009-22-00
- Status last verified
- Oct 2026
- First submitted
- 5 Jul 2024
- Last updated
- 23 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.