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
Status: Recruiting
Location: See all (191) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Aged ≥18 years at the time of signing the informed consent form (ICF).
• Able to understand the purpose and risks of the trial and voluntarily sign an ICF.
• Diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia (post-ET MF) or post-polycythemia vera (post-PV MF) according to the 2022 WHO criteria (WHO Classification of Tumours Editorial Board 2024), confirmed by local pathology report.
• Transfusion status as assessed in the 12 weeks immediately preceding randomization classified as Transfusion Dependent: 3 to 8 RBC units over 12 weeks.
• Receiving ruxolitinib (as approved in the country of the trial site) as the standard of care treatment for MF for at least 12 consecutive weeks, and on a stable daily dose for at least the 8 weeks immediately preceding the date of randomization.
• Eastern Cooperative Oncology Group score less than or equal to (≤) 2.
Locations
United States
Arizona
Banner MD Anderson Cancer Center
NOT_YET_RECRUITING
Gilbert
California
Los Angeles Cancer Network
NOT_YET_RECRUITING
Glendale
Cancer and Blood Specialty Clinic
NOT_YET_RECRUITING
Whittier
Washington, D.c.
MedStar Georgetown University Hospital
NOT_YET_RECRUITING
Washington D.c.
Florida
Advanced Research, LLC
RECRUITING
Coral Springs
Bioresearch Partners
NOT_YET_RECRUITING
Miami
AdventHealth - Cancer Institute - Orlando
NOT_YET_RECRUITING
Orlando
Florida Clinical Trials Group
NOT_YET_RECRUITING
Tamarac
Moffit Cancer Center
NOT_YET_RECRUITING
Tampa
Georgia
Emory University
NOT_YET_RECRUITING
Atlanta
Massachusetts
Tufts Medical Center
NOT_YET_RECRUITING
Boston
Missouri
Washington University School of Medicine
NOT_YET_RECRUITING
St Louis
Montana
St. Vincent Regional Hospital Cancer Centers
NOT_YET_RECRUITING
Billings
North Carolina
Duke Blood Cancer Center
NOT_YET_RECRUITING
Durham
Novant Health
NOT_YET_RECRUITING
Winston-salem
New Mexico
University of New Mexico Comprehensive Cancer Center
NOT_YET_RECRUITING
Albuquerque
New York
Icahn School of Medicine at Mount Sinai
NOT_YET_RECRUITING
New York
Memorial Sloan Kettering Cancer Center
NOT_YET_RECRUITING
New York
Ohio
Cleveland Clinic
NOT_YET_RECRUITING
Cleveland
Oregon
Oregon Health and Science University
NOT_YET_RECRUITING
Portland
Pennsylvania
Thomas Jefferson University
NOT_YET_RECRUITING
Philadelphia
Allegheny Health Network Cancer Institute - West Penn Hospital Location
NOT_YET_RECRUITING
Pittsburgh
University of Pittsburgh Medical Center
NOT_YET_RECRUITING
Pittsburgh
South Carolina
Medical University of South Carolina
NOT_YET_RECRUITING
Charleston
Tennessee
Vanderbilt-Ingram Cancer Center (VICC)-Nashville
NOT_YET_RECRUITING
Nashville
Texas
Baylor University Medical Center
NOT_YET_RECRUITING
Dallas
LUMI Research
RECRUITING
Houston
MD Anderson Cancer Center
NOT_YET_RECRUITING
Houston
The University of Utah-Huntsman Cancer Institute
NOT_YET_RECRUITING
Houston
Washington
University of Washington
NOT_YET_RECRUITING
Seattle
Other Locations
Argentina
Hospital Aleman (HA) Deutsches Hospital
NOT_YET_RECRUITING
Buenos Aires
Swiss Medical Center Barrio Parque
NOT_YET_RECRUITING
Buenos Aires
BRCR Global
NOT_YET_RECRUITING
Córdoba
Hospital Universitario Austral
NOT_YET_RECRUITING
Pilar
Hospital Privado de Rosario
NOT_YET_RECRUITING
Rosario
Instituto Medico de la Fundacion Estudios Clinicos
NOT_YET_RECRUITING
Rosario
Australia
Flinders Medical Centre
NOT_YET_RECRUITING
Bedford Park
Mid North Coast Cancer Institute (MNCCI)
NOT_YET_RECRUITING
Coffs Harbour
Tweed Valley Hospital
NOT_YET_RECRUITING
Cudgen
South Eastern Sydney Local Health District
NOT_YET_RECRUITING
Kogarah
Austria
Medizinische Universitat Innsbruck
NOT_YET_RECRUITING
Innsbruck
Ordensklinikum Linz Elisabethinen
NOT_YET_RECRUITING
Linz
Medizinische Universitat Wien (Medical University of Vienna - Austria)
NOT_YET_RECRUITING
Vienna
Klinikum Wels-Grieskirchen
NOT_YET_RECRUITING
Wels
Belgium
Ziekenhuis aan de Stroom-Cadix
NOT_YET_RECRUITING
Antwerp
Centre Hospitalier Jolimont-Lobbes
NOT_YET_RECRUITING
La Louvière
UZ Leuven
NOT_YET_RECRUITING
Leuven
AZ Delta
NOT_YET_RECRUITING
Roeselare
CHU Namur Site Mont Godinne
NOT_YET_RECRUITING
Yvoir
Brazil
Grupo Elora Pesquisa Clinica
NOT_YET_RECRUITING
Florianópolis
Hospital Amaral Carvalho (HAC)
NOT_YET_RECRUITING
Jaú
Centro de Hematologia e Oncologia (CHO)
NOT_YET_RECRUITING
Joinville
Hospital Mae De Deus - Integrated Oncology Center
NOT_YET_RECRUITING
Porto Alegre
Hospital Sao Lucas da PUCRS
NOT_YET_RECRUITING
Porto Alegre
Porto Alegre Clinical Hospital (HCPA)
NOT_YET_RECRUITING
Porto Alegre
Centro de Ensino, Pesquisa e Inovacao do Hospital Sao Lucas (CEPIN HSL RJ / Rede Americas)
NOT_YET_RECRUITING
Rio De Janeiro
Portuguese Charity of Sao Paulo
NOT_YET_RECRUITING
São Paulo
Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD
NOT_YET_RECRUITING
Pleven
Dr. Pencho Georgiev - Outpatient Center
NOT_YET_RECRUITING
Plovdiv
Specialized Hospital for Active Treatment of Haematological Diseases - Sofia
NOT_YET_RECRUITING
Sofia
UMHAT Sv. Ivan Rilski
NOT_YET_RECRUITING
Sofia
Canada
Juravinski Cancer Centre
NOT_YET_RECRUITING
Hamilton
Jewish General Hospital
NOT_YET_RECRUITING
Montreal
McGill University Health Center
NOT_YET_RECRUITING
Montreal
Princess Margaret Cancer Centre
NOT_YET_RECRUITING
Toronto
Chile
Hospital Cliniico Regional de Concepcion Dr
NOT_YET_RECRUITING
Concepción
IC La Serena Research
NOT_YET_RECRUITING
La Serena
Immunocel
NOT_YET_RECRUITING
Las Condes
Centro de Oncologia de Precision
NOT_YET_RECRUITING
Santiago
Icegclinic
NOT_YET_RECRUITING
Santiago
Colombia
Clinica General del Norte De Barranquilla
NOT_YET_RECRUITING
Barranquilla
Funcacion santa Fe De Bogota
NOT_YET_RECRUITING
Bogota
Los Cobos Medical Center
NOT_YET_RECRUITING
Bogotá
Hospital Pablo Tobon Uribe
NOT_YET_RECRUITING
Medellín
France
Centre Hospitalier Regional Universitaire Brest Hopital Morvan
NOT_YET_RECRUITING
Brest
Centre Hospitalier Regional Universitaire de Lille
NOT_YET_RECRUITING
Lille
Institut Paoli Calmettes
NOT_YET_RECRUITING
Marseille
CHU de Nice
NOT_YET_RECRUITING
Nice
Assistance Publique Hopitaux de Paris
NOT_YET_RECRUITING
Paris
CHU de Bordeaux
NOT_YET_RECRUITING
Pessac
Centre Hospitalier Lyon Sud
NOT_YET_RECRUITING
Pierre-bénite
CHU de Poitiers
NOT_YET_RECRUITING
Poitiers
CHU de Strasbourg
NOT_YET_RECRUITING
Strasbourg
Germany
Praxis am Volkspark
NOT_YET_RECRUITING
Berlin
Klinikum Chemnitz GmbH
NOT_YET_RECRUITING
Chemnitz
Universitaetsklinikum Freiburg
NOT_YET_RECRUITING
Freiburg Im Breisgau
University Hospital Halle (Saale)
NOT_YET_RECRUITING
Halle
Universitaetsklinikum Heidelberg (UKHD)
NOT_YET_RECRUITING
Heidelberg
Universitaetsklinikum Jena
NOT_YET_RECRUITING
Jena
Institut fur Versorgungsforschung in der Onkologie GbR
NOT_YET_RECRUITING
Koblenz
Muehlenkreiskliniken AoeR-Johannes Wesling Klinikum Minden - Universitaetsklinik fuer Neurologie und Neurogeriatrie
NOT_YET_RECRUITING
Minden
Kliniken Ostalb
NOT_YET_RECRUITING
Mutlangen
Greece
Alexandra General Hospital of Athens
NOT_YET_RECRUITING
Athens
General Hospital
NOT_YET_RECRUITING
Athens
Laiko General Hospital of Athens
NOT_YET_RECRUITING
Athens
University of Crete
NOT_YET_RECRUITING
Heraklion
Olympion General Clinic & Rehabilitation Center
NOT_YET_RECRUITING
Pátrai
Ippokrateion Hospital of Thessaloniki
NOT_YET_RECRUITING
Thessaloniki
Hungary
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika
NOT_YET_RECRUITING
Debrecen
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
NOT_YET_RECRUITING
Tatabánya
India
Apollo Specialty Hospitals
NOT_YET_RECRUITING
Chennai
Max Super Specialty Hospital
NOT_YET_RECRUITING
Delhi
Medanta- The Medicity- Gurugram
NOT_YET_RECRUITING
Gurgaon
Apollo Hospital Hyderabad
NOT_YET_RECRUITING
Hyderabad
Amrita Institute of Medical Sciences
NOT_YET_RECRUITING
Kochi
Tata Medical Center, Kolkata
NOT_YET_RECRUITING
Kolkata
All India Institute of Medical Science
NOT_YET_RECRUITING
New Delhi
Sahyadri Super Speciality Hospital Deccan
NOT_YET_RECRUITING
Pune
Rajiv Gandhi Cancer Institute and Research Centre
NOT_YET_RECRUITING
Rohini
Regional cancer Centre
NOT_YET_RECRUITING
Thiruvananthapuram
Ireland
Cork University Hospital
NOT_YET_RECRUITING
Cork
Mater Misericordiae University Hospital
NOT_YET_RECRUITING
Dublin
St James's Hospital
NOT_YET_RECRUITING
Dublin
University Hospital Galway
NOT_YET_RECRUITING
Galway
Israel
Carmel Medical Center
NOT_YET_RECRUITING
Haifa
Rambam Health Care Campus
NOT_YET_RECRUITING
Haifa
Hadassah Medical Organization, Hadassah Medical Center, Ein-
NOT_YET_RECRUITING
Jerusalem
Rabin Medical Center
NOT_YET_RECRUITING
Petah Tikva
The Tel Aviv Sourasky Medical Center
NOT_YET_RECRUITING
Tel Aviv
Italy
Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica
NOT_YET_RECRUITING
Ancona
IRCCS - AOU di Bologna - Sant Orsola Malpighi
NOT_YET_RECRUITING
Bologna
Policlinico Universitario di Catania
NOT_YET_RECRUITING
Catania
Universitaria di Ferrara Azienda Ospedaliero
NOT_YET_RECRUITING
Cona
Azienda Ospedaliera Universitaria Careggi
NOT_YET_RECRUITING
Florence
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l
NOT_YET_RECRUITING
Meldola
Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano
NOT_YET_RECRUITING
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NOT_YET_RECRUITING
Rome
Ospedale S Eugenio
NOT_YET_RECRUITING
Rome
Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
NOT_YET_RECRUITING
Rome
AOU Citta della Salute e della Scienza di Torino
NOT_YET_RECRUITING
Torino
Azienda Sanitaria Universitaria Friuli Centrale
NOT_YET_RECRUITING
Udine
Japan
Tokyo Metropolitan Komagome Hospital
NOT_YET_RECRUITING
Bunkyo-ku
Chiba Cancer Center
NOT_YET_RECRUITING
Chiba
University of Yamanashi Hospital
NOT_YET_RECRUITING
Chuo-shi
Hitachi General Hospital
NOT_YET_RECRUITING
Hitachi
Kobe City Medical Center General Hospital
NOT_YET_RECRUITING
Kobe
University of Miyazaki Hospital
NOT_YET_RECRUITING
Miyazaki
Ehime University Hospital
NOT_YET_RECRUITING
Toon-shi
Mie University Hospital
NOT_YET_RECRUITING
Tsu
Malaysia
Hospital Ampang
NOT_YET_RECRUITING
Ampang
Hospital Pulau Pinang
NOT_YET_RECRUITING
George Town
Hospital Queen Elizabeth
NOT_YET_RECRUITING
Kota Kinabalu
University Malaya Medical Centre
NOT_YET_RECRUITING
Kuala Lumpur
Mexico
Hematologica Alta Especialidad S.C.
NOT_YET_RECRUITING
Huixquilucan
Universidad Autonoma de Nuevo Leon
NOT_YET_RECRUITING
Monterrey
OSMO - Oaxaca Site Management Organization S.C
NOT_YET_RECRUITING
Oaxaca City
Poland
Zespol Szpitali Miejskich w Chorzowie
NOT_YET_RECRUITING
Chorzów
Pratia Oncology Katowice
NOT_YET_RECRUITING
Katowice
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Hematologii
NOT_YET_RECRUITING
Lodz
Pratia Poznan
NOT_YET_RECRUITING
Poznan
Wojewodzki Szpital Zespolony Im L Rydygiera
NOT_YET_RECRUITING
Torun
MTZ Clinical Research Powered by PRATIA
NOT_YET_RECRUITING
Warsaw
Republic of Korea
Daegu Catholic University Medical Center
NOT_YET_RECRUITING
Daegu
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
NOT_YET_RECRUITING
Seoul
Romania
Colentina Clinical Hospital
NOT_YET_RECRUITING
Bucharest
Institutul Oncologic Prof. Dr. Ion Chiricuta
NOT_YET_RECRUITING
Cluj-napoca
Spitalul Municipal Filantropia Craiova
NOT_YET_RECRUITING
Craiova
Spitalul Clinic Municipal de Urgenta Timisoara
NOT_YET_RECRUITING
Timișoara
Saudi Arabia
King Faisal Specialist Hospital & Research Centre Riyadh
NOT_YET_RECRUITING
Riyadh
King Khalid University Hospital
NOT_YET_RECRUITING
Riyadh
Spain
Institut Catala d'Oncologia
NOT_YET_RECRUITING
Badalona
Hospital Universitari Vall d'Hebron
NOT_YET_RECRUITING
Barcelona
Institut Catala d'Oncologia Hospital Duran y Renals
NOT_YET_RECRUITING
L'hospitalet De Llobregat
Hospital Universitario de Gran Canaria Doctor Negrin
NOT_YET_RECRUITING
Las Palmas De Gran Canaria
Hospital Ramon Y Cajal
NOT_YET_RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
NOT_YET_RECRUITING
Málaga
Universidad de Salamanca - Hospital Universitario de Salamanca
NOT_YET_RECRUITING
Salamanca
Hospital Universitari i Politecnic La Fe
NOT_YET_RECRUITING
Valencia
Sweden
Orebro University Hospital
NOT_YET_RECRUITING
Örebro
Karolinska University Hospital
NOT_YET_RECRUITING
Stockholm
Taiwan
Kaohsiung Medical University Hospital
NOT_YET_RECRUITING
Kaohsiung City
Taichung Veterans General Hospital
NOT_YET_RECRUITING
Taichung
National Cheng Kung University Hospital
NOT_YET_RECRUITING
Tainan
National Taiwan University Hospital
NOT_YET_RECRUITING
Taipei
Taipei Veterans General Hospital
NOT_YET_RECRUITING
Taipei
Turkey
Ankara Bilkent City Hospital
NOT_YET_RECRUITING
Çankaya
Istanbul Florence Nightingale Hospital
NOT_YET_RECRUITING
Istanbul
Istanbul University-CerrahpaAYa, CerrahpaAYa Faculty of Medicine
NOT_YET_RECRUITING
Istanbul
VM Medical Park Mersin Hospital
NOT_YET_RECRUITING
Mersin
United Kingdom
Birmingham Heartlands Hospital
NOT_YET_RECRUITING
Birmingham
University Hospital of Leicester NHS
NOT_YET_RECRUITING
Leicester
United Lincolnshire Teaching Hospitals NHS Trust
NOT_YET_RECRUITING
Lincoln
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
NOT_YET_RECRUITING
London
Imperial College Healthcare NHS Trust
NOT_YET_RECRUITING
London
UCL Cancer Institute - University College London Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
London
Sunderland and South Tyneside NHS Foundation Trust
NOT_YET_RECRUITING
Sunderland
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2026-09-02
Estimated Completion Date: 2034-03-30
Participants
Target number of participants: 324
Treatments
Experimental: Elritercept
Participants will receive elritercept at a starting dose of 3.75 milligrams per kilogram (mg/kg) subcutaneously (SC) once every 4 weeks (Q4W) on Day 1 of each 28-day cycle for approximately 36 weeks during the double-blinded treatment period, with possible up-titration to 5.0 mg/kg from Cycle 3 Day 1 based on response and safety/tolerability. Participants may continue to receive elritercept during the extended open-label treatment period.
Placebo_comparator: Placebo
Participants will receive elritercept-matching placebo with equivalent volume to elritercept SC Q4W on Day 1 of each 28-day cycle for approximately 36 weeks during the double-blinded treatment period. Eligible participants may initiate elritercept at a starting dose of 3.75 mg/kg SC Q4W on Day 1 of each 28-day cycle during the extended open-label treatment period, with possible up-titration to 5.0 mg/kg after 2 cycles, based on response and safety/tolerability.
Related Therapeutic Areas
Sponsors
Leads: Takeda