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A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
Sponsor: Takeda
Summary
The main aim of this study is to find out how well elritercept works to improve anemia in participants with myelofibrosis (MF) who are taking ruxolitinib when compared to placebo. Other aims are to learn how elritercept improves anemia compared to placebo; to learn if elritercept reduces tiredness, improves symptoms related to MF, and helps participants do physical activities more easily. The study also aims to find out how elritercept affects the bone marrow, the spleen, and whether participants develop antibodies to the study drug. The study will also check how safe elritercept is compared to placebo, and if elritercept stays safe over a long period of time. Participants will receive study treatment for at least 9 months (36 weeks). After this period, participants who received placebo will have the option to switch to elritercept.
Official title: A Phase 3, Double-Blind, Randomized Trial Evaluating the Efficacy and Safety of Elritercept (TAK-226) Compared to Placebo in Participants With Myelofibrosis and Anemia on Concurrent Ruxolitinib Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
324
Start Date
2026-09-10
Completion Date
2034-03-30
Last Updated
2026-10-01
Healthy Volunteers
No
Conditions
Interventions
Placebo
Elritercept-matching placebo
Elritercept
Elritercept, SC, injection
Locations (195)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Los Angeles Cancer Network
Glendale, California, United States
Cancer and Blood Specialty Clinic
Whittier, California, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Advanced Research, LLC
Coral Springs, Florida, United States
Bioresearch Partners
Miami, Florida, United States
AdventHealth - Cancer Institute - Orlando
Orlando, Florida, United States
Florida Clinical Trials Group
Tamarac, Florida, United States
Moffit Cancer Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Tufts Medical Center
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
St. Vincent Regional Hospital Cancer Centers
Billings, Montana, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Duke Blood Cancer Center
Durham, North Carolina, United States
Novant Health
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Allegheny Health Network Cancer Institute - West Penn Hospital Location
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt-Ingram Cancer Center (VICC)-Nashville
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
The University of Utah-Huntsman Cancer Institute
Houston, Texas, United States
LUMI Research
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina
Swiss Medical Center Barrio Parque
Buenos Aires, Ciudad Autonoma de BuenosAires, Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, Santa Fe Province, Argentina
Hospital Privado de Rosario
Rosario, Santa Fe Province, Argentina
Hospital Aleman (HA) Deutsches Hospital
Buenos Aires, Argentina
BRCR Global
Córdoba, Argentina
Flinders Medical Centre
Bedford Park, Adelaide, SA, Australia
Mid North Coast Cancer Institute (MNCCI)
Coffs Harbour, New South Wales, Australia
Tweed Valley Hospital
Cudgen, New South Wales, Australia
South Eastern Sydney Local Health District
Kogarah, New South Wales, Australia
Medizinische Universitat Wien (Medical University of Vienna - Austria)
Vienna, A, Austria
Medizinische Universitat Innsbruck
Innsbruck, Tyrol, Austria
Klinikum Wels-Grieskirchen
Wels, Upper Austria, Austria
Ordensklinikum Linz Elisabethinen
Linz, Austria
Centre Hospitalier Jolimont-Lobbes
La Louvière, Hainaut, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
AZ Delta
Roeselare, West-Vlaanderen, Belgium
Ziekenhuis aan de Stroom-Cadix
Antwerp, Belgium
CHU Namur Site Mont Godinne
Yvoir, Belgium
Centro de Ensino, Pesquisa e Inovacao do Hospital Sao Lucas (CEPIN HSL RJ / Rede Americas)
Rio de Janeiro, Rio de Janeiro, Brazil
Porto Alegre Clinical Hospital (HCPA)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Mae De Deus - Integrated Oncology Center
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Grupo Elora Pesquisa Clinica
Florianópolis, Santa Catarina, Brazil
Centro de Hematologia e Oncologia (CHO)
Joinville, Santa Catarina, Brazil
Hospital Amaral Carvalho (HAC)
Jaú, São Paulo, Brazil
Portuguese Charity of Sao Paulo
São Paulo, Brazil
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, Bulgaria
Dr. Pencho Georgiev - Outpatient Center
Plovdiv, Bulgaria
UMHAT Sv. Ivan Rilski
Sofia, Bulgaria
Specialized Hospital for Active Treatment of Haematological Diseases - Sofia
Sofia, Bulgaria
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Center
Montreal, Quebec, Canada
Hospital Cliniico Regional de Concepcion Dr
Concepción, Biobio, Chile
IC La Serena Research
La Serena, Coquimbo Region, Chile
Icegclinic
Santiago, La Florida, Chile
Immunocel
Las Condes, Santiago Metropolitan, Chile
Centro de Oncologia de Precision
Santiago, Santiago Metropolitan, Chile
Hospital Pablo Tobon Uribe
Medellín, Antioquia, Colombia
Clinica General del Norte De Barranquilla
Barranquilla, Atlántico, Colombia
Los Cobos Medical Center
Bogotá, Bogota D.C., Colombia
Funcacion santa Fe De Bogota
Bogota, Cundinamarca, Colombia
Masaryk University Hospital Brno, Department of Internal Medicine, Hematology and Oncology
Brno, Czech Republic, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, CZ, Czechia
Vseobecna fakultni nemocnice Praha
Prague, CZ, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
CHU de Nice
Nice, Alpes Maritimes, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France
CHU de Strasbourg
Strasbourg, Bas Rhin, France
Institut Paoli Calmettes
Marseille, Bouches-du-Rhone, France
Centre Hospitalier Regional Universitaire Brest Hopital Morvan
Brest, Finistere, France
CHU de Bordeaux
Pessac, Gironde, France
Centre Hospitalier Regional Universitaire de Lille
Lille, Nord, France
Assistance Publique Hopitaux de Paris
Paris, Paris, France
CHU de Poitiers
Poitiers, Vienne, France
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitaetsklinikum Heidelberg (UKHD)
Heidelberg, Baden-Wurttemberg, Germany
Kliniken Ostalb
Mutlangen, Baden-Wurttemberg, Germany
Muehlenkreiskliniken AoeR-Johannes Wesling Klinikum Minden - Universitaetsklinik fuer Neurologie und Neurogeriatrie
Minden, North Rhine-Westphalia, Germany
Institut fur Versorgungsforschung in der Onkologie GbR
Koblenz, Rhineland-Palatinate, Germany
Klinikum Chemnitz GmbH
Chemnitz, Saxony, Germany
University Hospital Halle (Saale)
Halle, Saxony-Anhalt, Germany
Universitaetsklinikum Jena
Jena, Thuringia, Germany
Praxis am Volkspark
Berlin, Germany
Olympion General Clinic & Rehabilitation Center
Pátrai, Ahaia, Greece
Laiko General Hospital of Athens
Athens, Attica, Greece
General Hospital
Athens, Attica, Greece
Alexandra General Hospital of Athens
Athens, Attica, Greece