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RECRUITING

NCT06499285

PHASE3

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

View on ClinicalTrials.gov

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. The study will also check on how safe elritercept is and how well it is tolerated.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

225

Start Date

2025-05-06

Completion Date

2032-05-01

Last Updated

2026-03-11

Healthy Volunteers

Conditions

Myelodysplastic Syndromes

Interventions

DRUG

Elritercept

Elritercept (TAK-226, KER-050) administered subcutaneously every 4 weeks.

DRUG

Placebo

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

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 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: * Del(5q) MDS or therapy-related (secondary) 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 ≥ 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 \[Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1\]).

Locations (155)

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

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

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

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (155)