A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
NCT ID: NCT06499285
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
225 participants
INTERVENTIONAL
2025-05-06
2032-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Elritercept
Participants will be administered elritercept (TAK-226, KER-050), subcutaneously every 4 weeks, up to 48 weeks or until the end of treatment period.
Elritercept
Elritercept (TAK-226, KER-050) administered subcutaneously every 4 weeks.
Placebo
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.
Placebo
Elritercept (TAK-226, KER-050) matching-placebo administered subcutaneously every 4 weeks.
Interventions
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Elritercept
Elritercept (TAK-226, KER-050) administered subcutaneously every 4 weeks.
Placebo
Elritercept (TAK-226, KER-050) matching-placebo administered subcutaneously every 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 aspirate, 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.
* Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either:
a. Low-transfusion burden (LTB), defined as 4 to 7 red blood cells (RBC) units per 16 weeks; or b. High-transfusion burden (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:
a. 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) ≥40,000 international units per week (IU/week) for ≥8 doses or equivalent; or ii. Darbepoetin alpha ≥500 micrograms (μg) every 3 weeks for ≥4 doses or equivalent.
b. 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.
c. 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% blasts in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader.
* 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).
Exclusion Criteria
* 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:
1. New York Heart Association heart disease class III or IV;
2. Fridericia corrected QT (QTcF) interval \>500 milliseconds during Screening;
3. 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
4. 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 ≥ 5 years. However, participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:
1. Basal or squamous cell carcinoma of the skin;
2. Carcinoma in situ of the cervix;
3. Carcinoma in situ of the breast; and/or
4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis \[TNM\] clinical staging system).
* 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.
* History of or known active chronic infection with HIV, hepatitis B virus (HBV), or 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 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 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 corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone lesser than or equal to (≤) 10 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 ≥450 × 10\^9/L or ≤25 × 10\^9/L.
* Absolute neutrophil count ≤ 500/µL.
* Serum aspartate aminotransferase or alanine aminotransferase ≥3 × the upper limit of normal (ULN).
* Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome.
* 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 contract research organization (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 \[Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1\]).
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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City of Hope
Duarte, California, United States
Los Angeles Cancer Network
Glendale, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States
University of Miami Hospital and Clinics
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
ILCC. Illinois Cancer Centers
Peoria, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Maryland Oncology Hematolofy
Columbia, Maryland, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
Clinical Research Alliance NY
Westbury, New York, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Cleveland Clinic - Cleveland
Cleveland, Ohio, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Baptist Clinical Research Institute
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Oncology Northeast Texas
Denison, Texas, United States
U.T. MD Anderson Cancer Center, Division of Cancer Medicine
Houston, Texas, United States
Texas Oncology Gulf Coast
The Woodlands, Texas, United States
Tranquil Research
Webster, Texas, United States
Westmead Hospital
Sydney, New South Wales, Australia
Townsville University Hospital
Douglas, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
St Vincent's Hospital (Melbourne) Ltd
Fitzroy, Victoria, Australia
Peter MacCallum Cancer Center
Parkville, Victoria, Australia
Porto Alegre Clinical Hospital (HCPA)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Mae de Deus, Clinical Research Unit - Cancer Institute
Porto Alegre, Rio Grande do Sul, Brazil
Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
Porto Alegre, Rio Grande do Sul, Brazil
Sao Jose do Rio Preto Regional Faculty of Medicine Foundation
São José do Rio Preto, São Paulo, Brazil
Americas Institute
Rio de Janeiro, , Brazil
Portuguese Charity of Sao Paulo, Clinical Hematology / Oncology Center
São Paulo, , Brazil
Hospital A.C.Camargo ("Antonio Prudente" Foundation)
São Paulo, , Brazil
Santa Casa of Mercy of Santos
São Paulo, , Brazil
Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD)
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology
Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical Academy, Clinic of Hematology
Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment "Sveta Marina", Clinic of Clinical Hematology
Varna, , Bulgaria
University of Alberta Hospital
Edmonton, Alberta, Canada
Providence Hematology - Vancouver
Vancouver, British Columbia, Canada
Nova Scotia Health Authority, Centre for Clinical Research
Halifax, Nova Scotia, Canada
London Health Sciences Centre
London, Ontario, Canada
Sunnybrook Research Institute, Odette Cancer Center
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Dr. Guillermo Grant Benavente - Concepcion Regional Hospital
Concepción, Bio Bio, Chile
IC La Serena Research
La Serena, Coquimbo Region, Chile
SAGA Clinical Research Center SpA
Santiago, , Chile
Clinic Inmunocel
Santiago, , Chile
Center for Clinical Studies and Medical Research (CECIM)
Santiago, , Chile
University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
Brno, , Czechia
University Hospital Hradec Kralove, 4th Internal Clinic of Hematology
Hradec Králové, , Czechia
University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
Prague, , Czechia
Institute of Hematology and Blood Transfusion, Division of Training and Development
Prague, , Czechia
Archet 1 and 2 hospital
Nice, , France
Saint-Louis Hospital
Paris, , France
Poitiers University Hospital Center - Miletrie Site
Poitiers, , France
IUCT-Oncopole
Toulouse, , France
University Hospital Bronn
Bonn, North Rhine-Westphalia, Germany
Marien Hospital Duesseldorf GmbH, Clinic for Oncology, Hematology and Palliative Medicine
Düsseldorf, North Rhine-Westphalia, Germany
University Hospital Leipzig, Clinic and Policlinic for Internal Medicine I Haematology and Stem Cell Therapy, Medical Oncology, Haemostaseology
Leipzig, Saxony, Germany
University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
Halle, Saxony-Anhalt, Germany
University Clinic of Hematology, Oncology and Cell Therapy
Magdeburg, Saxony-Anhalt, Germany
UKSH
Lübeck, Schleswig-Holstein, Germany
Praxis am Volkspark Berlin
Berlin, , Germany
Charite Universitatsmedizin Berlin
Berlin, , Germany
Semmelweis University, Department of Internal Medicine and Haematology, Division of Hematology
Budapest, , Hungary
University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology
Debrecen, , Hungary
Mor Kaposi General Hospital, Department of Hematology
Kaposvár, , Hungary
Szabolcs-Szatmar-Bereg County Teaching Hospital, Department of Hematology
Nyíregyháza, , Hungary
Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine III, Hematology
Székesfehérvár, , Hungary
Heamto Oncology Clinic Ahmedabad Pvt. Ltd.
Ahmedabad, Gujarat, India
Apollo Hospital International Ltd
Ahmedabad, Gujarat, India
Fortis Memorial Research Institute
Gurgaon, Haryana, India
Amrita Institute of Medical Sciences
Ernākulam, Kerala, India
Tata Memorial Centre
Mumbai, Maharashtra, India
Christian Medical College, Ludhianana
Ludhiana, Punjab, India
Christian Medical College
Vellore, Tamil Nadu, India
Max Super Speciality Hospital Vaishali (A Unit Of Crosslay Remedies Ltd.)
Ghaziabad, Uttar Pradesh, India
NRS Medical College and Hospital
Kolkata, West Bengal, India
Tata Medical Center, Kolkata
Kolkata, West Bengal, India
Postgraduate Institute of Medical Education and Research
Chandigarh, , India
Rajiv Gandhi Cancer Institute & Research Centre
Delhi, , India
Medanta the Medicity
Gurgaon, , India
Cork University Hospital
Cork, , Ireland
Beaumont Hospital
Dublin, , Ireland
Mater Misericordiae University Hospital
Dublin, , Ireland
Tallaght University Hospital
Dublin, , Ireland
St Vincent's University Hospital (SVUH)
Dublin, , Ireland
University Hospital Limerick
Limerick, , Ireland
Hadassah Medical Center, Department of Hematology
Jerusalem, , Israel
Rabin Medical Center, Davidoff Cancer Center, Hemato-Oncology Institute
Petah Tikva, , Israel
Chaim Sheba Medical Center, Department of Hematology, Myelodysplastic Syndromes Center
Ramat Gan, , Israel
The Tel Aviv Sourasky Medical Center, Department of Hematology and Bone Marrow Transplantation, Leukemia Service
Tel Aviv, , Israel
Careggi University Hospital
Florence, , Italy
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
Milan, , Italy
Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology
Pavia, , Italy
Foundation PTV - Polyclinic Tor Vergata
Rome, , Italy
Clinical Institute Humanitas, IRCCS
Rozzano, , Italy
Institute of Cancer Research and Treatment of Candiolo
Turin, , Italy
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, , Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, , Lithuania
Edgardo Rebagliati Martins National Hospital
Lima, Jesus Maria, Peru
Anglo American Clinic
Lima, La Molina, Peru
IPOR: Peruvian Institute of Oncology & Radiotherapy
Lima, San Isidro Lima, Peru
Daniel Alcides Carrion National Hospital
Bellavista, , Peru
National Institute of Neoplastic Diseases
Lima, , Peru
Pratia Oncology Katowice
Katowice, , Poland
Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz, General Hematology Unit
Lodz, , Poland
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, , Poland
Haemalife
Cape Town, , South Africa
Capital Haematology Hospital
Durban, , South Africa
Charlotte Maxeke Johannesburg Academic Hospital, Hemophilia Comprehensive Care Center
Johannesburg, , South Africa
Alberts Cellular Therapy
Pretoria, , South Africa
Kyungpook National University Hospital
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
University Clinical Hospital of Salamanca, Department of Hematology
Salamanca, Castille and León, Spain
University Hospital Vall d'Hebron, Department of Hematology
Barcelona, Catalonia, Spain
Catalan Institute of Oncology, Hospital Duran i Reynals, Department of Clinical Hematology
L'Hospitalet de Llobregat, Girona, Spain
University Hospital Ramon y Cajal
Madrid, Madrid, Spain
University Hospital Foundation Jimenez Diaz
Madrid, Madrid, Spain
University and Polytechnic Hospital La Fe
Valencia, Valencia, Spain
Karolinska University Hospital
Huddinge, Stockholm County, Sweden
Skane University Hospital - Lund, Department of Hematology and Vascular Disorders
Lund, , Sweden
Changhua Christian Hospital
Changhua, Changhua County, Taiwan
Chang Bing Show Chwan Memorial Hospital
Changhua, Changhua County, Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, , Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Rajavithi Hospital
Bangkok, , Thailand
Ramathibodi Hospital
Bangkok, , Thailand
Banphaeo General Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiangmai Hospital
Chiang Mai, , Thailand
Adana City Hospital
Adana, , Turkey (Türkiye)
Ankara Etlik City Hospital
Ankara, , Turkey (Türkiye)
Ankara University Medical Faculty Cebeci Hospital
Ankara, , Turkey (Türkiye)
Antalya Education and Training Hospital
Antalya, , Turkey (Türkiye)
Mersin Medicalpark Hospital
Mersin, , Turkey (Türkiye)
Sakarya University Medical Faculty Hospital
Sakarya, , Turkey (Türkiye)
Ondokuz Mayis University School of Medicine, Department of Hematology
Samsun, , Turkey (Türkiye)
Queen Elizabeth Hospital Birmingham
Birmingham, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
King's College Hospital
London, , United Kingdom
Sarah Cannon Research Institute (SCRI)
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-516009-22-00
Identifier Type: CTIS
Identifier Source: secondary_id
KER-050-D301
Identifier Type: -
Identifier Source: org_study_id
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