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A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions

Status: Recruiting
Location: See all (146) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The main aim of this study is to assess how elritercept works in lowering the need for RBC (red blood cell) transfusions and how safe elritercept is when compared with epoetin alfa. Other aims are to learn if elritercept improves tiredness as reported by participants without needing RBC transfusion compared with epoetin alfa, the RBC transfusion burden and quality of life compared with epoetin alfa. The study also aims to find out the extent of the immune response to elritercept. The study will also check on the medical problems (safety) of elritercept.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female participants aged ≥ 18 years or older at time of signing the informed consent form (ICF).

• Able to understand the purpose and risks of the trial and voluntarily sign an ICF prior to any trial-related procedures being conducted and authorization to use protected health information and personal data in accordance to national and local privacy regulations.

• Documented diagnosis of myelodysplastic syndrome(s) (MDS) according to WHO 2016 classification that meets International Prognostic Scoring System - Revised (IPSS-R) classification of very low-, low-, or intermediate-risk disease, confirmed by central laboratory independent reviewer prior to randomization. Hemoglobin (Hgb), platelet, and absolute neutrophil count (ANC) values should be collected greater than (\>) 14 days after red blood cell (RBC) transfusion or greater than (\>) 7 days after platelet transfusion, unless otherwise considered to be pretransfusion values.

• Bone marrow less than (\<) 5% blasts in an evaluable bone marrow collected at screening and confirmed by central pathology independent reviewer.

• Endogenous serum erythropoietin s (EPO) level of \<500 U/L. Should be results from blood samples collected \>14 days following an RBC transfusion to evaluate for eligibility unless considered pretransfusion values.

• Participant requires RBC transfusion, as documented by the following criteria. A transfusion requirement of 2 to 6 pRBCs units/8 weeks confirmed for a minimum of 8 weeks immediately preceding randomization.

• • Hgb levels at the time of or within 3 days prior to administration of a RBC transfusion must have been less than or equal to (≤) 9.0 grams per deciliter (g/dL) (5.6 millimoles per liter (mmol/L)) with symptoms of anemia (or ≤7 g/dL \[4.3 mmol/L\] in the absence of symptoms) in order for the transfusion to be counted towards meeting eligibility criteria.

• • RBC transfusions administered when hemoglobin (Hgb) levels were \>9.0 g/dL (or \>7 g/dL in the absence of symptoms) and/or RBC transfusions administered for elective surgery, infections or bleeding events will not qualify as a required transfusion for the purpose of meeting eligibility criteria or stratification.

• Hgb \<11.0 g/dL (6.8 mmol/L) after last RBC transfusion preceding randomization. Local laboratory is acceptable to facilitate randomization.

Locations
United States
California
Hematology-Oncology Medical Group of Orange County, Inc - Orange - 1010 W. La Veta Avenue
NOT_YET_RECRUITING
Orange
Florida
BRCR Medical Center Inc
RECRUITING
Tamarac
Georgia
Emory University
NOT_YET_RECRUITING
Atlanta
Illinois
Orchard Healthcare Research Inc. (OHR) - Skokie
RECRUITING
Skokie
Kentucky
Norton Cancer Institute
NOT_YET_RECRUITING
Louisville
Missouri
American Oncology Partners P.A. MidAmerica Cancer Care
NOT_YET_RECRUITING
Kansas City
North Carolina
Novant Health Care Institute
NOT_YET_RECRUITING
Winston-salem
New York
Albert Einstein College - Montefiore
NOT_YET_RECRUITING
The Bronx
Ohio
Cleveland clinic OH
NOT_YET_RECRUITING
Cleveland
Pennsylvania
Fox Chase Cancer Center
NOT_YET_RECRUITING
Philadelphia
Tennessee
Tennessee Oncology, PLLC
NOT_YET_RECRUITING
Nashville
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Texas
World Research Link
NOT_YET_RECRUITING
Baytown
The Center for Cancer and Blood Disorders
NOT_YET_RECRUITING
Fort Worth
The University of Texas-MD Anderson Cancer Center - Leukemia Center
NOT_YET_RECRUITING
Houston
Utah
Huntsman Cancer Institute
NOT_YET_RECRUITING
Salt Lake City
Virginia
Virginia Commonwealth University (VCU)-Medical Center - North Hospital
NOT_YET_RECRUITING
Richmond
West Virginia
West Virginia University Cancer Institute
NOT_YET_RECRUITING
Wheeling
Other Locations
Argentina
Swiss Medical Center - Barrio Parque
NOT_YET_RECRUITING
Buenos Aires
Hospital Privado de Cordoba
NOT_YET_RECRUITING
Córdoba
Sanatorio Allende S.A. - Nueva Cordoba
NOT_YET_RECRUITING
Córdoba
Instituto Medico de la Fundacion Estudios Clinicos
NOT_YET_RECRUITING
Rosario
Australia
Royal Adelaide Hospital
NOT_YET_RECRUITING
Adelaide
Flinders Medical Centre
NOT_YET_RECRUITING
Bedford Park
Monash University-Monash Medical Centre (MMC) - Clayton
NOT_YET_RECRUITING
Clayton
Mid North Coast Local Health District - Mid North Coast Cancer Institute (MNCCI) - Coffs Harbour
NOT_YET_RECRUITING
Coffs Harbour
Eastern Haematology & Oncology Group or Austin Hospital
NOT_YET_RECRUITING
Heidelberg
Alfred Hospital
NOT_YET_RECRUITING
Melbourne
Fiona Stanley Hospital
NOT_YET_RECRUITING
Murdoch
South Eastern Sydney Local Health District
NOT_YET_RECRUITING
Sydney
Calvary Mater Newcastle
NOT_YET_RECRUITING
Waratah
Belgium
UZ Leuven
NOT_YET_RECRUITING
Leuven
AZ Delta (H.-Hartziekenhuis Roeselare-Menen vzw (HHRM)) - Campus Rumbeke
NOT_YET_RECRUITING
Roeselare
Chu-Ucl Namur Site Godinne
NOT_YET_RECRUITING
Yvoir
Brazil
Hospital Amaral Carvalho (HAC)
NOT_YET_RECRUITING
Jaú
Centro de Hematologia e Oncologia (CHO)
NOT_YET_RECRUITING
Joinville
Hospital Mae de Deus, Clinical Research Unit - Cancer Institute
NOT_YET_RECRUITING
Porto Alegre
Porto Alegre Clinical Hospital (HCPA)
NOT_YET_RECRUITING
Porto Alegre
Santa Casa de Misericordia-Porto Alegre
NOT_YET_RECRUITING
Porto Alegre
D'OR Institute for Research and Education
NOT_YET_RECRUITING
Salvador
Irmandade da Santa Casa da Misericordia de Santos (ISCMS)
NOT_YET_RECRUITING
Santos
Hospital 9 de Julho (Rede Americas/DASA)
NOT_YET_RECRUITING
São Paulo
Portuguese Charity of Sao Paulo, Clinical Hematology / Oncology Center
NOT_YET_RECRUITING
São Paulo
Bulgaria
Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD)
NOT_YET_RECRUITING
Plovdiv
Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology
NOT_YET_RECRUITING
Sofia
Canada
London Health Sciences Centre (LHSC) - Victoria Hospital
NOT_YET_RECRUITING
London
Princess Margaret Cancer Centre
NOT_YET_RECRUITING
Toronto
St. Paul's Hospital (SPH) - Vancouver
NOT_YET_RECRUITING
Vancouver
France
Centre Hospitalier Universitaire Grenoble Alpes
NOT_YET_RECRUITING
La Tronche
Centre Hospitalier Universitaire (CHU) de Nice - Hopital L'Archet I - Hematologie Clinique
NOT_YET_RECRUITING
Nice
Saint-Louis Hospital
NOT_YET_RECRUITING
Paris
Poitiers University Hospital Center - Miletrie Site
NOT_YET_RECRUITING
Poitiers
Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Germany
Universitatsklinikum Bayreuth, Med. Klinik IV
NOT_YET_RECRUITING
Bayreuth
Charite Campus Benjamin Franklin
NOT_YET_RECRUITING
Berlin
Praxis am Volkspark
NOT_YET_RECRUITING
Berlin
University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
NOT_YET_RECRUITING
Halle
Gemeinschaftspraxis fuer Haematologie und Onkologie - Praxis Steinfurter Strasse
NOT_YET_RECRUITING
Münster
Greece
Democritus University of Thrace (DUTH) - University General Hospital of Alexandroupolis
NOT_YET_RECRUITING
Alexandroupoli
Laiko General Hospital
NOT_YET_RECRUITING
Athens
National and Kapodistrian University of Athens-University General Hospital Attikon
NOT_YET_RECRUITING
Athens
National and Kapodistrian University of Athens (NKUA)-Laiko General Hospital
NOT_YET_RECRUITING
Goudi
Faculty of Medicine, School of Health Sciences, University of Ioannina
NOT_YET_RECRUITING
Ioannina
General Hospital of Thessaloniki Ippokratio
NOT_YET_RECRUITING
Thessaloniki
Hungary
University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology
NOT_YET_RECRUITING
Debrecen
Szent Borbala Korhaz, Department of Internal Medicine and Haematology, Division of Hematology
NOT_YET_RECRUITING
Tatabánya
India
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
NOT_YET_RECRUITING
Chandigarh
Max SuperSpeciality Saket, Delhi
NOT_YET_RECRUITING
Delhi
Apollo Hospital Hyderabad
NOT_YET_RECRUITING
Hyderabad
AIMS, Kochi
NOT_YET_RECRUITING
Kochi
Tata Medical Center, Kolkata
NOT_YET_RECRUITING
Kolkata
Sahyadri Hospitals, Pune
NOT_YET_RECRUITING
Pune
Christian Medical College
NOT_YET_RECRUITING
Vellore
Ireland
Cork University Hospital
NOT_YET_RECRUITING
Cork
Mater Misericordiae University Hospital
NOT_YET_RECRUITING
Dublin
Italy
Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi - Istituto di Ematologia Lorenzo e Ariosto Seragnoli
NOT_YET_RECRUITING
Bologna
Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)
NOT_YET_RECRUITING
Florence
IRCCS Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
Ospedale Cardarelli
NOT_YET_RECRUITING
Naples
Ospedale di Novara
NOT_YET_RECRUITING
Novara
Universita degli Studi di Padova-Azienda Ospedaliera di Padova
NOT_YET_RECRUITING
Padova
Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology
NOT_YET_RECRUITING
Pavia
Policlinico Umberto I
NOT_YET_RECRUITING
Rome
Universita Degli Studi di Roma Tor Vergata
NOT_YET_RECRUITING
Rome
Gruppo Humanitas-Humanitas Research Hospital (Istituto Clinico Humanitas)
NOT_YET_RECRUITING
Rozzano
Institute of Cancer Research and Treatment of Candiolo
NOT_YET_RECRUITING
Torino
Japan
Hyogo Prefectural Amagasaki General Medical Center
NOT_YET_RECRUITING
Amagasaki
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
NOT_YET_RECRUITING
Bunkyo-ku
Fukushima Medical University Hospital
NOT_YET_RECRUITING
Fukushima
Chugoku Central Hospital
NOT_YET_RECRUITING
Fukuyama
Gifu Municipal Hospital
NOT_YET_RECRUITING
Gifu
Dokkyo Medical University Hospital
NOT_YET_RECRUITING
Kitakobayashi
NHO Nagoya Medical Center
NOT_YET_RECRUITING
Naka-ku
NTT Medical Center Tokyo
NOT_YET_RECRUITING
Shinagawa-ku
Lithuania
Hospital of Lithuania University of Health Sciences Kaunas, Clinic of Oncology and Hematology
NOT_YET_RECRUITING
Kaunas
Vilniaus Universiteto Ligonine Santaros Klinikos (VULSK) (Vilniaus Universiteto Ligonines Santariskiu Klinikos)
NOT_YET_RECRUITING
Vilnius
Malaysia
Hospital Sultanah Bahiyah (HSB) (Klinik Kesihatan Bandar Alor Setar/Hospital Alor Setar)
NOT_YET_RECRUITING
George Town
Hospital Sultanah Aminah Johor Bahru (HSAJB)
NOT_YET_RECRUITING
Johor Bahru
Universiti Malaya - Faculty of Medicine (FOM)
NOT_YET_RECRUITING
Kuala Lumpur
Mexico
National Institute of Medical Sciences and Nutrition Salvado
NOT_YET_RECRUITING
México
Universidad Autonoma de Nuevo Leon-Hospital Universitario Dr. Jose Eleuterio Gonzalez - Servicio de Hematologia
NOT_YET_RECRUITING
Monterrey
Centro de Investigacion Clinica Chapultepec (CICC), S.A. de C.V
NOT_YET_RECRUITING
Morelia
Oaxaca Site Management Organization S.C. - Oaxaca
NOT_YET_RECRUITING
Oaxaca City
Clinica Ruiz - Centro de Hematologia y Medicina Interna (CHMI)
NOT_YET_RECRUITING
Puebla City
Netherlands
Amsterdam UMC-Locatie VUMC (Vrije Universiteit Medisch Centrum)
NOT_YET_RECRUITING
Amsterdam
Norway
Helse Bergen HF
NOT_YET_RECRUITING
Bergen
Oslo Universitetssykehus HF
NOT_YET_RECRUITING
Oslo
Sykehuset Vestfold HF
NOT_YET_RECRUITING
Tønsberg
Poland
Pratia Onkologia Katowice
NOT_YET_RECRUITING
Katowice
Pratia MCM Krakow
NOT_YET_RECRUITING
Krakow
AidPort
NOT_YET_RECRUITING
Skorzewo
Warszawski Uniwersytet Medyczny (WUM) (Medical University of Warsaw)
NOT_YET_RECRUITING
Warsaw
Pratia Wroclaw
NOT_YET_RECRUITING
Wroclaw
Republic of Korea
Seoul National University Bundang Hospital
NOT_YET_RECRUITING
Seongnam-si
Korea University Anam Hospital
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Soon Chun Hyang University Hospital Seoul
NOT_YET_RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
NOT_YET_RECRUITING
Seoul
Romania
Institutul Oncologic Prof. Dr. I. Chiricu
NOT_YET_RECRUITING
Cluj-napoca
Spain
Hospital Universitari Vall d'Hebron-Institut de Recerca (VHIR)
NOT_YET_RECRUITING
Barcelona
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals Location
NOT_YET_RECRUITING
L'hospitalet De Llobregat
University Hospital Ramon y Cajal
NOT_YET_RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria (HUVV)
NOT_YET_RECRUITING
Málaga
Universidad de Salamanca - Hospital Universitario de Salamanca
NOT_YET_RECRUITING
Salamanca
Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
NOT_YET_RECRUITING
Seville
University and Polytechnic Hospital La Fe
NOT_YET_RECRUITING
Valencia
Taiwan
Chang Bing Show Chwan Memorial Hospital
NOT_YET_RECRUITING
Changhua
Kaohsiung Medical University Chung-Ho Memorial Hospital
NOT_YET_RECRUITING
Kaohsiung City
China Medical University Hospital
NOT_YET_RECRUITING
Taichung
National Cheng Kung University Hospital
NOT_YET_RECRUITING
Tainan
National Taiwan University Hospital - East Campus
NOT_YET_RECRUITING
Taipei
Taipei Veterans General Hospital
NOT_YET_RECRUITING
Taipei
Thailand
Banphaeo General Hospital
NOT_YET_RECRUITING
Ban Phaeo
King Chulalongkorn Memorial Hospital
NOT_YET_RECRUITING
Bangkok
Maharaj Nakorn Chiangmai Hospital
NOT_YET_RECRUITING
Chiang Mai
Turkey
Ankara Universitesi, TAp FakAltesi, Hematoloji BD
NOT_YET_RECRUITING
Ankara
Istanbul Florence Nightingale Hospital
NOT_YET_RECRUITING
Istanbul
Ege University Medical Faculty
NOT_YET_RECRUITING
Izmir
Mersin Medicalpark Hospital
NOT_YET_RECRUITING
Mersin
Ondokuz Mayis University School of Medicine, Department of Hematology
NOT_YET_RECRUITING
Samsun
United Kingdom
Queen Elizabeth Hospital Birmingham
NOT_YET_RECRUITING
Birmingham
Pilgrim Hospital
NOT_YET_RECRUITING
Boston
King's College Hospital
NOT_YET_RECRUITING
London
The Christie NHS Foundation Trust
NOT_YET_RECRUITING
Manchester
Churchill Hospital
NOT_YET_RECRUITING
Oxford
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2033-10-01
Participants
Target number of participants: 300
Treatments
Experimental: Elritercept
Participants will receive a starting dose of elritercept at 3.75 milligrams per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks, and may have the dose escalated to 5.0 mg/kg if needed,
Active_comparator: Epoetin Alfa
Participants will receive a starting dose of epoetin Alfa at 450 international units per kilograms (IU/kg) administered SC once every week, and may have the dose escalated up to 1050 IU/kg.
Related Therapeutic Areas
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov

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