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RECRUITING
NCT07623161
PHASE3

A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib

Sponsor: Takeda

View on ClinicalTrials.gov

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

2026-08-25

Completion Date

2034-03-30

Last Updated

2026-07-23

Healthy Volunteers

No

Interventions

DRUG

Placebo

Elritercept-matching placebo

DRUG

Elritercept

Elritercept, SC, injection

Locations (207)

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

University of Michigan

Ann Arbor, Michigan, 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

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Novant Health

Winston-Salem, North Carolina, United States

Atrium Health Wake Forest Baptist

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

Baptist Clinical Research Institute

Memphis, Tennessee, United States

Vanderbilt-Ingram Cancer Center (VICC)-Nashville

Nashville, Tennessee, United States

Next Innovative Clinical Research

Baytown, Texas, 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

The Canberra Hospital

Garran, Australian Capital Territory, Australia

Mid North Coast Cancer Institute (MNCCI)

Coffs Harbour, New South Wales, Australia

South Eastern Sydney Local Health District

Kogarah, New South Wales, Australia

St Vincents Hospital Melbourne

Fitzroy, Victoria, Australia

The Canberra Hospital

Heidelberg, Australia

Medizinische Universitat Innsbruck

Innsbruck, Tyrol, Austria

Klinikum Wels-Grieskirchen

Wels, Upper Austria, Austria

Ordensklinikum Linz Elisabethinen

Linz, Austria

Medizinische Universitat Wien (Medical University of Vienna - Austria)

Vienna, Austria

Centre Hospitalier Jolimont-Lobbes

La Louvière, Hainaut, Belgium

CHU Namur Site Mont Godinne

Yvoir, Namur, Belgium

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

AZ Delta

Roeselare, West-Vlaanderen, Belgium

Ziekenhuis aan de Stroom-Cadix

Antwerp, 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, Pleven Province, 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

University Hospital Sveta Marina, Clinic of Clinical Hematology

Varna, Bulgaria

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

LHSC - Victoria Hospital

London, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Hotel Dieu Hospital of Levis

Lévis, Quebec, 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

CECIM

Santiago, Region Metropolitana Santiago de Chile, 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, 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

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

University General Hospital of Patras

Pátrai, Achaia, Greece

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

University of Crete

Heraklion, Crete, Greece

Ippokrateion Hospital of Thessaloniki

Thessaloniki, Macedonia, Greece

Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika

Debrecen, HB, Hungary

Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, Komarom-Esztergom VArmegye, Hungary

Medanta- The Medicity- Gurugram

Gurgaon, Haryana, India

Amrita Institute of Medical Sciences

Kochi, Kerala, India

Sahyadri Super Speciality Hospital Deccan

Pune, Maharashtra, India

Rajiv Gandhi Cancer Institute and Research Centre

Rohini, NEW Delhi, India

Apollo Specialty Hospitals

Chennai, Tamil Nadu, India

Apollo Hospital Hyderabad

Hyderabad, Telangana, India

Tata Medical Center, Kolkata

Kolkata, West Bengal, India

Max Super Specialty Hospital

Delhi, India

Cork University Hospital

Cork, Ireland

St James's Hospital

Dublin, Ireland

Mater Misericordiae University Hospital

Dublin, Ireland

University Hospital Galway

Galway, Ireland

Rabin Medical Center

Petah Tikva, Central District, Israel

Rambam Health Care Campus

Haifa, North, Israel

The Tel Aviv Sourasky Medical Center

Tel Aviv, TLV, Israel

Carmel Medical Center

Haifa, Israel

Hadassah Medical Organization, Hadassah Medical Center, Ein-

Jerusalem, Israel

IRCCS - AOU di Bologna - Sant Orsola Malpighi

Bologna, BO, Italy

Universitaria di Ferrara Azienda Ospedaliero

Cona, Ferrara, Italy

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l

Meldola, Forli-Cesena, Italy

Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma

Rome, Lazio, Italy

Ospedale S Eugenio

Rome, Lazio, Italy

Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano

Milan, MI, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, RM, Italy

Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica

Ancona, Italy

Policlinico Universitario di Catania

Catania, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

AOU Citta della Salute e della Scienza di Torino

Torino, Italy

Azienda Sanitaria Universitaria Friuli Centrale

Udine, Italy

Chiba Cancer Center

Chiba, Chiba, Japan

Ehime University Hospital

Toon-shi, Ehime, Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Hitachi General Hospital

Hitachi, Ibaraki, Japan

Mie University Hospital

Tsu, Mie-ken, Japan

University of Miyazaki Hospital

Miyazaki, Miyazaki, Japan

Tokyo Metropolitan Komagome Hospital

Bunkyo-Ku, Tokyo, Japan

University of Yamanashi Hospital

Chuo-shi, Yamanashi, Japan

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Hospital Pulau Pinang

George Town, Pulau Pinang, Malaysia

Hospital Queen Elizabeth

Kota Kinabalu, Sabah, Malaysia

Hospital Ampang

Ampang, Selangor, Malaysia

Hematologica Alta Especialidad S.C.

Huixquilucan, Mexico de Mexico, Mexico

Universidad Autonoma de Nuevo Leon

Monterrey, Mexic, Mexico

OSMO - Oaxaca Site Management Organization S.C

Oaxaca City, Oaxaca, Mexico

Pratia Poznan

Poznan, Greater Poland Voivodeship, Poland

Wojewodzki Szpital Zespolony Im L Rydygiera

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Pratia MCM Krakow

Krakow, Lesser Poland Voivodeship, Poland

MTZ Clinical Research Powered by PRATIA

Warsaw, Masovian Voivodeship, Poland

Zespol Szpitali Miejskich w Chorzowie

Chorzów, Silesian Voivodeship, Poland

Pratia Oncology Katowice

Katowice, Silesian Voivodeship, Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Hematologii

Lodz, Łódź Voivodeship, Poland

Colentina Clinical Hospital

Bucharest, Bucharest, Romania

Institutul Oncologic Prof. Dr. Ion Chiricuta

Cluj-Napoca, CJ, Romania

Spitalul Municipal Filantropia Craiova

Craiova, Dolj, Romania

Spitalul Clinic Municipal de Urgenta Timisoara

Timișoara, Romania

King Abdulaziz University Hospital

Jeddah, Al Sharafiyyah District Jeddah, Saudi Arabia

King Faisal Specialist Hospital & Research Centre Riyadh

Riyadh, Saudi Arabia

King Khalid University Hospital

Riyadh, Saudi Arabia

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Korea University Anam Hospital

Seoul, Seongbuk-gu, South Korea

Soon Chun Hyang University Hospital Seoul

Seoul, Seoul Teugbyeolsi, South Korea

Daegu Catholic University Medical Center

Daegu, South Korea

The Catholic University of Korea

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Hospital Clinico Universitario de Santiago

Santiago de Compostela, A Coruna, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Andalusia, Spain

Institut Catala d'Oncologia

Badalona, Barcelona, Spain

Institut Catala d'Oncologia Hospital Duran y Renals

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, LAS Palmas, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Ramon Y Cajal

Madrid, Spain

Universidad de Salamanca - Hospital Universitario de Salamanca

Salamanca, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Skanes universitetssjukhus Lund-Dep. of hematology, oncology and radiation physics

Lund, Sweden

Orebro University Hospital

Örebro, Sweden

Karolinska University Hospital

Stockholm, Sweden

Taipei Veterans General Hospital

Taipei, Beitou, Taiwan

National Cheng Kung University Hospital

Tainan, Tainan City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan (r.o.c.), Taiwan

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Ankara Bilkent City Hospital

Çankaya, Ankara, Turkey (Türkiye)

VM Medical Park Mersin Hospital

Mersin, Mezitli, Turkey (Türkiye)

Istanbul University-CerrahpaAYa, CerrahpaAYa Faculty of Medicine

Istanbul, Turkey (Türkiye)

Istanbul Florence Nightingale Hospital

Istanbul, Turkey (Türkiye)

United Lincolnshire Teaching Hospitals NHS Trust

Lincoln, East Midlands, United Kingdom

University Hospital of Leicester NHS

Leicester, Leicestershire, United Kingdom

Imperial College Healthcare NHS Trust

London, London, City of, United Kingdom

Sunderland and South Tyneside NHS Foundation Trust

Sunderland, Tyne and Wear, United Kingdom

Birmingham Heartlands Hospital

Birmingham, W Mids, United Kingdom

UCL Cancer Institute - University College London Hospitals NHS Foundation Trust

London, United Kingdom

Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

London, United Kingdom