RECRUITING Phase 3 ClinicalTrials.gov

A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions

Sponsor: Takeda • ClinicalTrials.gov ID: NCT06499285

Registry updated: 2026-10-08

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Description

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.

Interventions

Elritercept (Drug)
Elritercept (TAK-226, KER-050) administered subcutaneously every 4 weeks.
Placebo (Drug)
Elritercept (TAK-226, KER-050) matching-placebo administered subcutaneously every 4 weeks.

Eligibility criteria

Inclusion Criteria: * 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: a. 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: 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) ≥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. 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 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). Exclusion Criteria: * 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: 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 ≥ 2 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). 5. 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 \[Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1\]).

Conditions

Myelodysplastic Syndromes

Locations

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
Ghattas Oncology — Monroe, Louisiana, United States
Maryland Oncology Hematolofy — Columbia, Maryland, United States
MidAmerica Cancer Care — Kansas City, Missouri, United States
Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
Clinical Research Alliance NY — Westbury, New York, United States
Novant Health-Cancer Institute — Winston-Salem, North Carolina, United States
Gabrail Cancer Center Research — Canton, Ohio, United States
Cleveland Clinic - Cleveland — Cleveland, Ohio, United States
Tennessee Cancer Specialists — Knoxville, 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
LUMI Research — Houston, Texas, United States
Epic Medical Research — Red Oak, Texas, United States
Texas Oncology Gulf Coast — The Woodlands, Texas, United States
Tranquil Research — Webster, Texas, United States
Epic Care Emeryville — Issaquah, Washington, United States
The Canberra Hospital — Garran, Australian Capital Territory, Australia
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
Alfred Health — Melbourne, Victoria, Australia
Peter MacCallum Cancer Center — Parkville, Victoria, Australia
Hosptial Erasto Gaertner — Curitiba, Paraná, Brazil
Porto Alegre Clinical Hospital (HCPA) — Porto Alegre, Rio Grande do Sul, Brazil
Hospital Mae de Deus, Clinical Research Unit - Cancer Institute — Porto Alegre, Rio Grande do Sul, Brazil
Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital — Porto Alegre, Rio Grande do Sul, Brazil
Instituto Joinvilense de Hematologia e Oncologia — Joinville, Santa Catarina, Brazil
FundaAAo Doutor Amaral Carvalho — Jaú, São Paulo, Brazil
Cepho- Fmabc — Santo André, São Paulo, 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, Biobio, 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
Charles University General Hospital — Ostrava, Czechia
University Hospital Ostrava and Faculty of Medicine, University of Ostrava — Ostrava, 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
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
Amrita Institute of Medical Sciences — Ernākulam, Kerala, India
Tata Memorial Centre — Mumbai, Maharashtra, India
All India Institute of Medical Science — New Delhi, National Capital Territory of Delhi, 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
Rajiv Gandhi Cancer Institute & Research Centre — Delhi, India
Medanta the Medicity — Gūrgaon, 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
Aou Delle Marche — Ancona, AN, Italy
AO Ordine Mauriziano — Turin, Piedmont, Italy
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
Granda Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' — Reggio Calabria, 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 Poznan — Poznan, Greater, Poland
Pratia Onkologia Wroclaw — Wroclaw, Lower Silesian Voivodeship, Poland
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
A-rebro University Hospital, Hematology Department — Örebro, A-rebro County, Sweden
Karolinska University Hospital — Huddinge, Stockholm County, Sweden
Sahlgrenska University Hospital — Gothenburg, VG, Sweden
Skane University Hospital - Lund, Department of Hematology and Vascular Disorders — Lund, Sweden
University Hosptial Basel — Basel, Canton of Basel-City, Switzerland
Insel Gruppe AG, University Clinic for Hematology and Central Hematological Laboratory — Bern, Switzerland
Universitatsspital Zurich, Klinik fur Medizinische Onkologie und Hamatologie — Zurich, Switzerland
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 City, 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)
Aberdeen Royal Infirmary — Aberdeen, Aberdeen City, United Kingdom
Glan Clwyd Hospital — Rhyl, Denbighshire, United Kingdom
University Hospitals of Leicester — Leicester, Leics, United Kingdom
Lincolnshire Community and Hospitals NHS group — Lincoln, Lincolnshire, United Kingdom
The Newcastle Upon Tyne University Hospitals Foundation Trust — High Heaton, Tyne and Wear, United Kingdom
South Tyneside and Sunderland Foundation Trust — Sunderland, Tyne and Wear, United Kingdom
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

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