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

20 août 2026 mis à jour par: Takeda

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

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

324

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Allemagne
      • Berlin, Allemagne, 10715
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Allemagne, 79106
        • Pas encore de recrutement
        • Universitaetsklinikum Freiburg
        • Contact:
        • Chercheur principal:
          • Heiko Becker
      • Heidelberg, Baden-Wurttemberg, Allemagne, 69120
        • Pas encore de recrutement
        • Universitaetsklinikum Heidelberg (UKHD)
        • Contact:
        • Chercheur principal:
          • Tim Sauer
      • Mutlangen, Baden-Wurttemberg, Allemagne, 73557
        • Pas encore de recrutement
        • Kliniken Ostalb
        • Chercheur principal:
          • Holger Hebart
        • Contact:
    • North Rhine-Westphalia
      • Minden, North Rhine-Westphalia, Allemagne, 32429
        • Pas encore de recrutement
        • Muehlenkreiskliniken AoeR-Johannes Wesling Klinikum Minden - Universitaetsklinik fuer Neurologie und Neurogeriatrie
        • Chercheur principal:
          • Martin Griesshammer
        • Contact:
    • Rhineland-Palatinate
      • Koblenz, Rhineland-Palatinate, Allemagne, 56068
        • Pas encore de recrutement
        • Institut fur Versorgungsforschung in der Onkologie GbR
        • Contact:
        • Chercheur principal:
          • Cristoph Lutz
    • Saxony
      • Chemnitz, Saxony, Allemagne, 9116
        • Pas encore de recrutement
        • Klinikum Chemnitz GmbH
        • Chercheur principal:
          • Mathias Hanel
        • Contact:
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Allemagne, 06120
        • Pas encore de recrutement
        • University Hospital Halle (Saale)
        • Chercheur principal:
          • Haifa Kathrin Al-Ali
        • Contact:
    • Thuringia
      • Jena, Thuringia, Allemagne, 7743
        • Pas encore de recrutement
        • Universitaetsklinikum Jena
        • Chercheur principal:
          • Carl Crodel
        • Contact:
  • Arabie Saoudite
      • Riyadh, Arabie Saoudite, 12372
        • Pas encore de recrutement
        • King Khalid University Hospital
        • Contact:
        • Chercheur principal:
          • Musa Alzahrani
      • Riyadh, Arabie Saoudite, 11211
        • Pas encore de recrutement
        • King Faisal Specialist Hospital & Research Centre Riyadh
        • Contact:
        • Chercheur principal:
          • Marwan Shaheen
  • Argentine
      • Buenos Aires, Argentine, CPC1118AAT
        • Pas encore de recrutement
        • Hospital Aleman (HA) Deutsches Hospital
        • Contact:
        • Chercheur principal:
          • Maria De Los Angeles Vicente Reparaz
      • Córdoba, Argentine, 5000
        • Pas encore de recrutement
        • BRCR Global
        • Contact:
        • Chercheur principal:
          • Karla Di Sisto
    • Buenos Aires
      • Pilar, Buenos Aires, Argentine, B1629AHJ
        • Pas encore de recrutement
        • Hospital Universitario Austral
        • Contact:
        • Chercheur principal:
          • Silvio Carricondo
    • Ciudad Autonoma de BuenosAires
      • Buenos Aires, Ciudad Autonoma de BuenosAires, Argentine, 1405
        • Pas encore de recrutement
        • Swiss Medical Center Barrio Parque
        • Chercheur principal:
          • Claudio Marcelo Iastrebner
        • Contact:
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentine, 2000
        • Pas encore de recrutement
        • Instituto Medico de la Fundacion Estudios Clinicos
        • Chercheur principal:
          • Gustavo Jorge Braidot
        • Contact:
      • Rosario, Santa Fe Province, Argentine, S2000GAP
        • Pas encore de recrutement
        • Hospital Privado de Rosario
        • Chercheur principal:
          • Jose Luis Fedele
        • Contact:
  • Australie
    • Adelaide, SA
      • Bedford Park, Adelaide, SA, Australie, 5042
        • Pas encore de recrutement
        • Flinders Medical Centre
        • Chercheur principal:
          • David Ross
        • Contact:
    • New South Wales
      • Coffs Harbour, New South Wales, Australie, 2450
        • Pas encore de recrutement
        • Mid North Coast Cancer Institute (MNCCI)
        • Chercheur principal:
          • Kyle Crassini
        • Contact:
      • Cudgen, New South Wales, Australie, 2487
        • Pas encore de recrutement
        • Tweed Valley Hospital
        • Chercheur principal:
          • Steven Wong
        • Contact:
      • Kogarah, New South Wales, Australie, 2217
        • Pas encore de recrutement
        • South Eastern Sydney Local Health District
        • Contact:
        • Chercheur principal:
          • Sundreswran (Sundra) Ramanathan
  • Belgique
      • Antwerp, Belgique, 2030
        • Pas encore de recrutement
        • Ziekenhuis aan de Stroom-Cadix
        • Chercheur principal:
          • Nikki Granacher
        • Contact:
      • Yvoir, Belgique, 5530
        • Pas encore de recrutement
        • CHU Namur Site Mont Godinne
        • Contact:
        • Chercheur principal:
          • Julien Devreux
    • Hainaut
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgique, 3000
        • Pas encore de recrutement
        • UZ Leuven
        • Chercheur principal:
          • Timothy Devos
        • Contact:
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgique, 8800
        • Pas encore de recrutement
        • AZ Delta
        • Chercheur principal:
          • Lien Deleu
        • Contact:
  • Brésil
      • São Paulo, Brésil, 01323-900
        • Pas encore de recrutement
        • Portuguese Charity of Sao Paulo
        • Chercheur principal:
          • Phillip Scheinberg
        • Contact:
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brésil, 90610-000
        • Pas encore de recrutement
        • Hospital Sao Lucas da PUCRS
        • Chercheur principal:
          • Mariza Schaan
        • Contact:
      • Porto Alegre, Rio Grande do Sul, Brésil, 90035-903
        • Pas encore de recrutement
        • Porto Alegre Clinical Hospital (HCPA)
        • Chercheur principal:
          • Laura Maria Fogliatto
        • Contact:
      • Porto Alegre, Rio Grande do Sul, Brésil, 90110-270
        • Pas encore de recrutement
        • Hospital Mae De Deus - Integrated Oncology Center
        • Chercheur principal:
          • Marcelo Capra
        • Contact:
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brésil, 22061080
        • Pas encore de recrutement
        • Centro de Ensino, Pesquisa e Inovacao do Hospital Sao Lucas (CEPIN HSL RJ / Rede Americas)
        • Contact:
        • Chercheur principal:
          • Cristiane Solza
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brésil, 88020-210
        • Pas encore de recrutement
        • Grupo Elora Pesquisa Clinica
        • Contact:
        • Chercheur principal:
          • Jaisson Bortolini
      • Joinville, Santa Catarina, Brésil, 89201-260
        • Pas encore de recrutement
        • Centro de Hematologia e Oncologia (CHO)
        • Chercheur principal:
          • Marcelo Pitombeira de Lacerda
        • Contact:
    • São Paulo
      • Jaú, São Paulo, Brésil, 17210-080
        • Pas encore de recrutement
        • Hospital Amaral Carvalho (HAC)
        • Chercheur principal:
          • Ederson Mattos
        • Contact:
  • Bulgarie
      • Pleven, Bulgarie, 5800
        • Pas encore de recrutement
        • UMHAT 'Dr. Georgi Stranski', EAD
        • Contact:
        • Chercheur principal:
          • Vanya Slavcheva-Popova
      • Plovdiv, Bulgarie, 4002
        • Pas encore de recrutement
        • Dr. Pencho Georgiev - Outpatient Center
        • Chercheur principal:
          • Pencho Georgiev
        • Contact:
      • Sofia, Bulgarie, 1431
        • Pas encore de recrutement
        • UMHAT Sv. Ivan Rilski
        • Chercheur principal:
          • Atanas Radinoff
        • Contact:
      • Sofia, Bulgarie, 1797
        • Pas encore de recrutement
        • Specialized Hospital for Active Treatment of Haematological Diseases - Sofia
        • Chercheur principal:
          • Martin Donchev
        • Contact:
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Pas encore de recrutement
        • Juravinski Cancer Centre
        • Chercheur principal:
          • Hillis Christopher
        • Contact:
          • Site Contact
          • Numéro de téléphone: 905 387 9495
          • E-mail: hillis@hhsc.ca
      • Toronto, Ontario, Canada, M5G 2M9
        • Pas encore de recrutement
        • Princess Margaret Cancer Centre
        • Contact:
        • Chercheur principal:
          • Dawn Maze
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Pas encore de recrutement
        • McGill University Health Center
        • Chercheur principal:
          • Jonathan How
        • Contact:
      • Montreal, Quebec, Canada, H3T1E2
        • Pas encore de recrutement
        • Jewish General Hospital
        • Chercheur principal:
          • Shireen Sirhan
        • Contact:
  • Chili
    • Biobio
      • Concepción, Biobio, Chili, 4030000
        • Pas encore de recrutement
        • Hospital Cliniico Regional de Concepcion Dr
        • Chercheur principal:
          • Monica Romero
        • Contact:
    • Coquimbo Region
      • La Serena, Coquimbo Region, Chili, 01697
        • Pas encore de recrutement
        • IC La Serena Research
        • Chercheur principal:
          • Cleiden Villegas
        • Contact:
    • La Florida
      • Santiago, La Florida, Chili, 8241479
        • Pas encore de recrutement
        • Icegclinic
        • Contact:
        • Chercheur principal:
          • Carlos Avendano
    • Santiago Metropolitan
      • Las Condes, Santiago Metropolitan, Chili, 7560908
        • Pas encore de recrutement
        • Immunocel
        • Chercheur principal:
          • Alejandro Berkovits
        • Contact:
      • Santiago, Santiago Metropolitan, Chili, 7850000
        • Pas encore de recrutement
        • Centro de Oncologia de Precision
        • Contact:
        • Chercheur principal:
          • Ignacio Corvalan
  • Colombie
    • Antioquia
      • Medellín, Antioquia, Colombie, 0000000
        • Pas encore de recrutement
        • Hospital Pablo Tobon Uribe
        • Contact:
        • Chercheur principal:
          • Kenny Galvez
    • Atlántico
      • Barranquilla, Atlántico, Colombie, 080002
        • Pas encore de recrutement
        • Clinica General del Norte De Barranquilla
        • Contact:
        • Chercheur principal:
          • Arturo Guzman
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombie, 110121
        • Pas encore de recrutement
        • Los Cobos Medical Center
        • Contact:
        • Chercheur principal:
          • Jheremy Reyes
    • Cundinamarca
      • Bogota, Cundinamarca, Colombie, 11011
        • Pas encore de recrutement
        • Funcacion santa Fe De Bogota
        • Contact:
        • Chercheur principal:
          • Claudia Agudelo
  • Corée du Sud
      • Daegu, Corée du Sud, 42472
        • Pas encore de recrutement
        • Daegu Catholic University Medical Center
        • Chercheur principal:
          • Sung Hwa Bae
        • Contact:
      • Seoul, Corée du Sud, 3080
        • Pas encore de recrutement
        • Seoul National University Hospital
        • Chercheur principal:
          • Junshik Hong
        • Contact:
      • Seoul, Corée du Sud, 137-701
        • Pas encore de recrutement
        • The Catholic University of Korea
        • Chercheur principal:
          • Sung-Eun Lee
        • Contact:
    • Gangnam-gu
      • Seoul, Gangnam-gu, Corée du Sud
        • Pas encore de recrutement
        • Samsung Medical Center
        • Contact:
        • Chercheur principal:
          • Chul Won Jung
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Corée du Sud, 13620
        • Pas encore de recrutement
        • Seoul National University Bundang Hospital
        • Chercheur principal:
          • Soo-Mee Bang
        • Contact:
    • Seongbuk-gu
      • Seoul, Seongbuk-gu, Corée du Sud
        • Pas encore de recrutement
        • Korea University Anam Hospital
        • Chercheur principal:
          • Yong Park
        • Contact:
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Corée du Sud, 04401
        • Pas encore de recrutement
        • Soon Chun Hyang University Hospital Seoul
        • Chercheur principal:
          • Seug Yun Yoon
        • Contact:
  • Espagne
      • Barcelona, Espagne, 08035
        • Pas encore de recrutement
        • Hospital Universitari Vall d'Hebron
        • Chercheur principal:
          • Maria Laura Fox
        • Contact:
      • Madrid, Espagne, 28034
        • Pas encore de recrutement
        • Hospital Ramon y Cajal
        • Contact:
        • Chercheur principal:
          • Jose Valentin Garcia-Gutierrez
      • Salamanca, Espagne, 37007
        • Pas encore de recrutement
        • Universidad de Salamanca - Hospital Universitario de Salamanca
        • Chercheur principal:
          • Jesús María Hernández Rivas
        • Contact:
          • Site Contact
          • Numéro de téléphone: 626308549
          • E-mail: jmhr@usal.es
      • Valencia, Espagne, 46026
        • Pas encore de recrutement
        • Hospital Universitari i Politecnic La Fe
        • Chercheur principal:
          • Elvira Mora Castera
        • Contact:
    • Barcelona
      • Badalona, Barcelona, Espagne, 8916
        • Pas encore de recrutement
        • Institut Catala D'oncologia
        • Chercheur principal:
          • Blanca Xicoy Cirici
        • Contact:
      • L'Hospitalet de Llobregat, Barcelona, Espagne, 08908
        • Pas encore de recrutement
        • Institut Catala d'Oncologia Hospital Duran y Renals
        • Contact:
        • Chercheur principal:
          • Jasson Villarreal
    • LAS Palmas
      • Las Palmas de Gran Canaria, LAS Palmas, Espagne, 35010
        • Pas encore de recrutement
        • Hospital Universitario de Gran Canaria Doctor Negrin
        • Chercheur principal:
          • Adrian Segura Diaz
        • Contact:
    • M
      • Málaga, M, Espagne, 29003
        • Pas encore de recrutement
        • Hospital Universitario Virgen de la Victoria
        • Chercheur principal:
          • Regina Garcia-Delgado
        • Contact:
  • France
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 6002
        • Pas encore de recrutement
        • Chu De Nice
        • Chercheur principal:
          • Michael Loschi
        • Contact:
    • Auvergne-Rhône-Alpes
      • Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495
        • Pas encore de recrutement
        • Centre Hospitalier LYON SUD
        • Chercheur principal:
          • Vincent Alcazer
        • Contact:
    • Bas Rhin
      • Strasbourg, Bas Rhin, France, 67200
        • Pas encore de recrutement
        • CHU de Strasbourg
        • Contact:
        • Chercheur principal:
          • Shanti Ame
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13009
        • Pas encore de recrutement
        • Institut Paoli Calmettes
        • Contact:
        • Chercheur principal:
          • Jerome Rey
    • Finistere
      • Brest, Finistere, France, 29609
        • Pas encore de recrutement
        • Centre Hospitalier Regional Universitaire Brest Hopital Morvan
        • Chercheur principal:
          • Jean-Christophe Ianotto
        • Contact:
    • Gironde
      • Pessac, Gironde, France, 33600
        • Pas encore de recrutement
        • CHU de Bordeaux
        • Contact:
        • Chercheur principal:
          • Clemence Mediavilla
    • Nord
      • Lille, Nord, France, 59037
        • Pas encore de recrutement
        • Centre Hospitalier Regional Universitaire de Lille
        • Contact:
        • Chercheur principal:
          • Mathieu Wemeau
    • Paris
      • Paris, Paris, France, 75015
        • Pas encore de recrutement
        • Assistance Publique Hopitaux De Paris
        • Contact:
        • Chercheur principal:
          • Lina Benajiba
    • Vienne
      • Poitiers, Vienne, France, 86021
  • Grèce
    • Ahaia
      • Pátrai, Ahaia, Grèce, 264 43
        • Pas encore de recrutement
        • Olympion General Clinic & Rehabilitation Center
        • Chercheur principal:
          • Argiris Symeonidis
        • Contact:
    • Attica
      • Athens, Attica, Grèce, 11528
        • Pas encore de recrutement
        • Alexandra General Hospital of Athens
        • Chercheur principal:
          • Meletios-Athanasios Dimopoulos
        • Contact:
      • Athens, Attica, Grèce, 11526
        • Pas encore de recrutement
        • Laiko General Hospital of Athens
        • Chercheur principal:
          • Theodoros Vassilakopoulos
        • Contact:
      • Athens, Attica, Grèce, 11527
        • Pas encore de recrutement
        • General Hospital
        • Chercheur principal:
          • Panagiotis Diamantopoulos
        • Contact:
    • Crete
      • Heraklion, Crete, Grèce, 70013
        • Pas encore de recrutement
        • University of Crete
        • Contact:
        • Chercheur principal:
          • Nikolaos Sousos
    • Macedonia
      • Thessaloniki, Macedonia, Grèce, 54642
        • Pas encore de recrutement
        • Ippokrateion Hospital of Thessaloniki
        • Contact:
        • Chercheur principal:
          • Eleni Gavriilaki
  • Hongrie
    • HB
      • Debrecen, HB, Hongrie, 4032
        • Pas encore de recrutement
        • Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika
        • Chercheur principal:
          • Arpad Illes
        • Contact:
    • Komarom-Esztergom VArmegye
      • Tatabánya, Komarom-Esztergom VArmegye, Hongrie, 2800
        • Pas encore de recrutement
        • Komárom-Esztergom Vármegyei Szent Borbála Kórház
        • Chercheur principal:
          • Zsofia Simon
        • Contact:
  • Inde
      • Delhi, Inde, 201012
        • Pas encore de recrutement
        • Max Super Specialty Hospital
        • Chercheur principal:
          • Rayaz Ahmed
        • Contact:
    • Haryana
      • Gurgaon, Haryana, Inde, 122001
        • Pas encore de recrutement
        • Medanta- The Medicity- Gurugram
        • Chercheur principal:
          • Nitin Sood
        • Contact:
    • Kerala
      • Kochi, Kerala, Inde, 682041
        • Pas encore de recrutement
        • Amrita Institute of Medical Sciences
        • Contact:
        • Chercheur principal:
          • Neeraj Sidharthan
      • Thiruvananthapuram, Kerala, Inde, 695011
        • Pas encore de recrutement
        • Regional Cancer Centre
        • Contact:
        • Chercheur principal:
          • Sungeeth Thambi
    • Maharashtra
      • Pune, Maharashtra, Inde, 411004
        • Pas encore de recrutement
        • Sahyadri Super Speciality Hospital Deccan
        • Contact:
        • Chercheur principal:
          • Shashikant Janardhan Apte
    • NEW Delhi
      • Rohini, NEW Delhi, Inde, 110085
        • Pas encore de recrutement
        • Rajiv Gandhi Cancer Institute And Research Centre
        • Chercheur principal:
          • Dinesh Bhurani
        • Contact:
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, Inde, 110029
        • Pas encore de recrutement
        • All India Institute of Medical Science
        • Contact:
        • Chercheur principal:
          • Ranjit Sahoo
    • Tamil Nadu
      • Chennai, Tamil Nadu, Inde, 382424
        • Pas encore de recrutement
        • Apollo Specialty Hospitals
        • Chercheur principal:
          • Velu Nair
        • Contact:
    • Telangana
      • Hyderabad, Telangana, Inde, 500096
        • Pas encore de recrutement
        • Apollo Hospital Hyderabad
        • Contact:
        • Chercheur principal:
          • Padmaja Lokireddy
    • West Bengal
      • Kolkata, West Bengal, Inde, 700 160
        • Pas encore de recrutement
        • Tata Medical Center, Kolkata
        • Chercheur principal:
          • Arijit Nag
        • Contact:
  • Irlande
      • Cork, Irlande, T12 DC4A
        • Pas encore de recrutement
        • Cork University Hospital
        • Contact:
        • Chercheur principal:
          • Clodagh Keohane
      • Dublin, Irlande, D08 NHY1
        • Pas encore de recrutement
        • St James's Hospital
        • Chercheur principal:
          • Catherine Flynn
        • Contact:
      • Dublin, Irlande, D15 W8Y7
        • Pas encore de recrutement
        • Mater Misericordiae University Hospital
        • Chercheur principal:
          • Su Maung
        • Contact:
      • Galway, Irlande, H91YR71
        • Pas encore de recrutement
        • University Hospital Galway
        • Chercheur principal:
          • Janusz Krawczyk
        • Contact:
  • Israël
      • Haifa, Israël, 3436212
        • Pas encore de recrutement
        • Carmel Medical Center
        • Chercheur principal:
          • Elena Mishchenko
        • Contact:
      • Jerusalem, Israël, 9112001
        • Pas encore de recrutement
        • Hadassah Medical Organization, Hadassah Medical Center, Ein-
        • Chercheur principal:
          • David Lavie
        • Contact:
      • Petah Tikva, Israël, 4941492
        • Pas encore de recrutement
        • Rabin Medical Center
        • Contact:
        • Chercheur principal:
          • Adi Shacham-Abulafia
    • North
      • Haifa, North, Israël, 3109601
        • Pas encore de recrutement
        • Rambam Health Care Campus
        • Contact:
        • Chercheur principal:
          • Inna Tzoran
    • TLV
      • Tel Aviv, TLV, Israël, 64239
        • Pas encore de recrutement
        • The Tel Aviv Sourasky Medical Center
        • Chercheur principal:
          • Ilya Kirgner
        • Contact:
  • Italie
      • Ancona, Italie, 60121
        • Pas encore de recrutement
        • Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica
        • Contact:
        • Chercheur principal:
          • Erika Morsia
      • Catania, Italie, 95124
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        • Policlinico Universitario di Catania
        • Chercheur principal:
          • Giuseppe Palumbo
        • Contact:
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        • Azienda Ospedaliera Universitaria Careggi
        • Chercheur principal:
          • Alessandro Maria Vannucchi
        • Contact:
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        • AOU Citta della Salute e della Scienza di Torino
        • Contact:
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          • Benevolo Giulia
      • Udine, Italie, 33100
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        • Azienda Sanitaria Universitaria Friuli Centrale
        • Chercheur principal:
          • Mario Tiribelli
        • Contact:
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      • Bologna, BO, Italie, 40138
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        • IRCCS - AOU di Bologna - Sant Orsola Malpighi
        • Chercheur principal:
          • FRANCESCA PALANDRI
        • Contact:
    • Ferrara
      • Cona, Ferrara, Italie, 44124
        • Pas encore de recrutement
        • Universitaria di Ferrara Azienda Ospedaliero
        • Contact:
        • Chercheur principal:
          • Giuseppe Auteri
    • Forli-Cesena
      • Meldola, Forli-Cesena, Italie, 47014
        • Pas encore de recrutement
        • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l
        • Chercheur principal:
          • Alessandro Lucchesi
        • Contact:
    • Lazio
      • Rome, Lazio, Italie, 00161
        • Pas encore de recrutement
        • Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
        • Chercheur principal:
          • Massimo Breccia
        • Contact:
      • Rome, Lazio, Italie, 144
        • Pas encore de recrutement
        • Ospedale S Eugenio
        • Chercheur principal:
          • Elisabetta Abruzzese
        • Contact:
    • MI
      • Milan, MI, Italie, 20122
        • Pas encore de recrutement
        • Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano
        • Chercheur principal:
          • Francesco Passamonti
        • Contact:
    • RM
      • Rome, RM, Italie, 00168
        • Pas encore de recrutement
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
        • Chercheur principal:
          • Elena Rossi
  • Japon
    • Chiba
      • Chiba, Chiba, Japon, 260-8717
        • Pas encore de recrutement
        • Chiba Cancer Center
        • Chercheur principal:
          • Masahiro Takeuchi
        • Contact:
    • Ehime
      • Toon-shi, Ehime, Japon, 791-0295
        • Pas encore de recrutement
        • Ehime University Hospital
        • Contact:
        • Chercheur principal:
          • Katsuto Takenaka
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      • Kobe, Hyōgo, Japon, 650-0047
        • Pas encore de recrutement
        • Kobe City Medical Center General Hospital
        • Contact:
          • Site Contact
          • Numéro de téléphone: 78-302-4321
        • Chercheur principal:
          • Yuya Nagai
    • Ibaraki
      • Hitachi, Ibaraki, Japon, 317-0077
        • Pas encore de recrutement
        • Hitachi General Hospital
        • Contact:
        • Chercheur principal:
          • Atsushi Shinagawa
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      • Tsu, Mie-ken, Japon, 514-8507
        • Pas encore de recrutement
        • Mie University Hospital
        • Contact:
          • Site Contact
          • Numéro de téléphone: 81(0)59-232-1111
        • Chercheur principal:
          • Yuka Sugimoto
    • Miyazaki
      • Miyazaki, Miyazaki, Japon, 889-1692
        • Pas encore de recrutement
        • University of Miyazaki Hospital
        • Contact:
          • Site Contact
          • Numéro de téléphone: 81-985-85-1510
        • Chercheur principal:
          • Kazuya Shimoda
    • Tokyo
      • Bunkyo-Ku, Tokyo, Japon, 113-8677
        • Pas encore de recrutement
        • Tokyo Metropolitan Komagome Hospital
        • Contact:
          • Site Contact
          • Numéro de téléphone: 3-3823-2101
          • E-mail: n-doki@cick.jp
        • Chercheur principal:
          • Noriko Doki
    • Yamanashi
      • Chuo-shi, Yamanashi, Japon, 409-3898
        • Pas encore de recrutement
        • University of Yamanashi Hospital
        • Chercheur principal:
          • Keita Kirito
        • Contact:
  • L'Autriche
      • Linz, L'Autriche, 4020
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        • Ordensklinikum Linz Elisabethinen
        • Chercheur principal:
          • Veronika Buxhofer-Ausch
        • Contact:
    • A
      • Vienna, A, L'Autriche, 1090
        • Pas encore de recrutement
        • Medizinische Universitat Wien (Medical University of Vienna - Austria)
        • Contact:
        • Chercheur principal:
          • Maria-Theresa Krauth
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      • Innsbruck, Tyrol, L'Autriche, 6020
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        • Medizinische Universität Innsbruck
        • Contact:
        • Chercheur principal:
          • Dominik Wolf
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      • Wels, Upper Austria, L'Autriche, 4600
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        • Klinikum Wels-Grieskirchen
        • Chercheur principal:
          • Sonja Heibl
        • Contact:
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    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaisie, 59100
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        • University Malaya Medical Centre
        • Contact:
        • Chercheur principal:
          • Edmund Fui Min Chin
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      • George Town, Pulau Pinang, Malaisie, 10990
        • Pas encore de recrutement
        • Hospital Pulau Pinang
        • Contact:
        • Chercheur principal:
          • Hong Keng Liew
    • Sabah
      • Kota Kinabalu, Sabah, Malaisie, 88586
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        • Hospital Queen Elizabeth
        • Contact:
        • Chercheur principal:
          • Khaiteri Raghunathan
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      • Ampang, Selangor, Malaisie, 68000
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        • Hospital Ampang
        • Chercheur principal:
          • Veena Selvaratnam
        • Contact:
  • Mexique
    • Mexic
      • Monterrey, Mexic, Mexique, 64710
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        • Universidad Autonoma de Nuevo Leon
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          • David Gomez Almaguer
        • Contact:
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      • Huixquilucan, Mexico de Mexico, Mexique, 52787
        • Pas encore de recrutement
        • Hematologica Alta Especialidad S.C.
        • Contact:
        • Chercheur principal:
          • Roberto Ovilla Martinez
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      • Oaxaca City, Oaxaca, Mexique, 68000
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        • OSMO - Oaxaca Site Management Organization S.C
        • Contact:
        • Chercheur principal:
          • Eva Ramirez Romero
  • Pologne
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Pologne, 60-192
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        • Pratia Poznań
        • Chercheur principal:
          • Anna Hoppe
        • Contact:
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      • Torun, Kuyavian-Pomeranian Voivodeship, Pologne, 87-100
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        • Wojewodzki Szpital Zespolony Im L Rydygiera
        • Chercheur principal:
          • Dominik Chraniuk
        • Contact:
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Pologne, 02-172
        • Pas encore de recrutement
        • MTZ Clinical Research Powered by PRATIA
        • Chercheur principal:
          • Krzysztof Madry
        • Contact:
    • Silesian Voivodeship
      • Chorzów, Silesian Voivodeship, Pologne, 41-500
        • Pas encore de recrutement
        • Zespol Szpitali Miejskich w Chorzowie
        • Contact:
        • Chercheur principal:
          • Piotr Malecki
      • Katowice, Silesian Voivodeship, Pologne, 40-519
        • Pas encore de recrutement
        • Pratia Oncology Katowice
        • Chercheur principal:
          • Sebastian Grosicki
        • Contact:
          • Site Contact
          • Numéro de téléphone: 48 600388282
          • E-mail: sgrosicki@wp.pl
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Pologne, 93-513
        • Pas encore de recrutement
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Hematologii
        • Contact:
        • Chercheur principal:
          • Joanna Gora-Tybor
  • Roumanie
      • Bucharest, Roumanie, 20125
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        • Colentina Clinical Hospital
        • Chercheur principal:
          • Mihaela Andreescu
        • Contact:
      • Timișoara, Roumanie, 300700
        • Pas encore de recrutement
        • Spitalul Clinic Municipal de Urgenta Timisoara
        • Contact:
        • Chercheur principal:
          • Ioana Ionita
    • CJ
      • Cluj-Napoca, CJ, Roumanie, 400124
        • Pas encore de recrutement
        • Institutul Oncologic Prof. Dr. Ion Chiricuta
        • Chercheur principal:
          • Ciprian Tomuleasa
        • Contact:
    • Dolj
      • Craiova, Dolj, Roumanie, 200143
        • Pas encore de recrutement
        • Spitalul Municipal Filantropia Craiova
        • Chercheur principal:
          • Luminita Ocroteala
        • Contact:
  • Royaume-Uni
      • London, Royaume-Uni, SE1 9RT
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        • Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
        • Chercheur principal:
          • Claire Harrison
        • Contact:
      • London, Royaume-Uni, NW1 2PG
        • Pas encore de recrutement
        • UCL Cancer Institute - University College London Hospitals NHS Foundation Trust
        • Chercheur principal:
          • Jonathan Lambert
        • Contact:
    • East Midlands
      • Lincoln, East Midlands, Royaume-Uni, LN2 5QY
        • Pas encore de recrutement
        • United Lincolnshire Teaching Hospitals NHS Trust
        • Chercheur principal:
          • Ciro Rinaldi
        • Contact:
    • Leicestershire
      • Leicester, Leicestershire, Royaume-Uni, LE1 5WW
        • Pas encore de recrutement
        • University Hospital of Leicester NHS
        • Chercheur principal:
          • Mamta Garg
        • Contact:
    • London, City of
      • London, London, City of, Royaume-Uni, W12 0HS
        • Pas encore de recrutement
        • Imperial College Healthcare NHS Trust
        • Chercheur principal:
          • Simone Claudiani
        • Contact:
    • Tyne and Wear
      • Sunderland, Tyne and Wear, Royaume-Uni, SR4 7TP
        • Pas encore de recrutement
        • Sunderland and South Tyneside NHS Foundation Trust
        • Chercheur principal:
          • Scott Marshall
        • Contact:
    • W Mids
      • Birmingham, W Mids, Royaume-Uni
        • Pas encore de recrutement
        • Birmingham Heartlands Hospital
        • Contact:
        • Chercheur principal:
          • Joanne Ewing
  • Suède
      • Stockholm, Suède, 14186
        • Pas encore de recrutement
        • Karolinska University Hospital
        • Chercheur principal:
          • Anne-Marie Landtblom
        • Contact:
      • Örebro, Suède, 70185
        • Pas encore de recrutement
        • Örebro University Hospital
        • Contact:
        • Chercheur principal:
          • Erik Ahlstrand
  • Taïwan
      • Kaohsiung City, Taïwan
        • Pas encore de recrutement
        • Kaohsiung Medical University Hospital
        • Chercheur principal:
          • Yi-Chang Liu
        • Contact:
      • Taichung, Taïwan, 40705
        • Pas encore de recrutement
        • Taichung Veterans General Hospital
        • Contact:
        • Chercheur principal:
          • Tsung Chih Chen
      • Tainan, Taïwan, 70403
        • Pas encore de recrutement
        • National Cheng Kung University Hospital
        • Chercheur principal:
          • Tsai-Yun Chen
        • Contact:
    • Beitou
      • Taipei, Beitou, Taïwan, 11217
        • Pas encore de recrutement
        • Taipei Veterans General Hospital
        • Chercheur principal:
          • Chih-Cheng Chen
        • Contact:
    • Taiwan (r.o.c.)
      • Taipei, Taiwan (r.o.c.), Taïwan, 100
        • Pas encore de recrutement
        • National Taiwan University Hospital
        • Chercheur principal:
          • Hsin-An Hou
        • Contact:
  • Tchéquie
      • Prague, Tchéquie, 134 00
        • Pas encore de recrutement
        • Fakultni nemocnice Kralovske Vinohrady
        • Chercheur principal:
          • Olga Cerna
        • Contact:
    • CZ
      • Hradec Králové, CZ, Tchéquie, 50005
        • Pas encore de recrutement
        • Fakultni nemocnice Hradec Kralove
        • Chercheur principal:
          • Petra Belohlavkova
        • Contact:
      • Prague, CZ, Tchéquie, 12808
        • Pas encore de recrutement
        • Vseobecna fakultni nemocnice Praha
        • Chercheur principal:
          • Anna Jonasova
        • Contact:
    • Czech Republic
      • Brno, Czech Republic, Tchéquie, 625 00
        • Pas encore de recrutement
        • Masaryk University Hospital Brno, Department of Internal Medicine, Hematology and Oncology
        • Contact:
        • Chercheur principal:
          • Barbora Weinbergerova
  • Turquie (Türkiye)
      • Istanbul, Turquie (Türkiye), 34381
        • Pas encore de recrutement
        • Istanbul Florence Nightingale Hospital
        • Contact:
        • Chercheur principal:
          • Omur Sevindik
      • Istanbul, Turquie (Türkiye), 34303
        • Pas encore de recrutement
        • Istanbul University-CerrahpaAYa, CerrahpaAYa Faculty of Medicine
        • Contact:
        • Chercheur principal:
          • Ahmet Emre Eskazan
    • Ankara
      • Çankaya, Ankara, Turquie (Türkiye), 06800
        • Pas encore de recrutement
        • Ankara Bilkent City Hospital
        • Contact:
        • Chercheur principal:
          • Marve Pamukcuoglu
    • Mezitli
      • Mersin, Mezitli, Turquie (Türkiye), 33000
        • Pas encore de recrutement
        • VM Medical Park Mersin Hospital
        • Chercheur principal:
          • Anil Tombak
        • Contact:
  • États-Unis
    • Arizona
      • Gilbert, Arizona, États-Unis, 85234
        • Pas encore de recrutement
        • Banner MD Anderson Cancer Center
        • Chercheur principal:
          • Mark Faber
        • Contact:
    • California
      • Glendale, California, États-Unis, 91204
        • Pas encore de recrutement
        • Los Angeles Cancer Network
        • Contact:
        • Chercheur principal:
          • Saro Kasparian
      • Whittier, California, États-Unis, 90603
        • Pas encore de recrutement
        • Cancer and Blood Specialty Clinic
        • Chercheur principal:
          • Merrill Shum
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, États-Unis, 20007
        • Pas encore de recrutement
        • MedStar Georgetown University Hospital
        • Contact:
        • Chercheur principal:
          • Julia Cunningham
    • Florida
      • Coral Springs, Florida, États-Unis, 33065
        • Recrutement
        • Advanced Research, LLC
        • Chercheur principal:
          • Sumit Sawhney
        • Contact:
      • Miami, Florida, États-Unis, 33143
        • Pas encore de recrutement
        • Bioresearch Partners
        • Chercheur principal:
          • Luis Rangel
        • Contact:
      • Orlando, Florida, États-Unis, 32804-4648
        • Pas encore de recrutement
        • AdventHealth - Cancer Institute - Orlando
        • Contact:
        • Chercheur principal:
          • Ahmed Zakari
      • Tamarac, Florida, États-Unis, 33321
        • Pas encore de recrutement
        • Florida Clinical Trials Group
        • Chercheur principal:
          • Chintan Gandhi
        • Contact:
      • Tampa, Florida, États-Unis, 33612
        • Pas encore de recrutement
        • Moffit Cancer Center
        • Chercheur principal:
          • Andrew Kuykendall
        • Contact:
    • Georgia
      • Atlanta, Georgia, États-Unis, 30322
        • Pas encore de recrutement
        • Emory University
        • Contact:
        • Chercheur principal:
          • Anthony Hunter
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02111
        • Pas encore de recrutement
        • Tufts Medical Center
        • Contact:
        • Chercheur principal:
          • Parva Bhatt
    • Missouri
      • St Louis, Missouri, États-Unis, 63110
        • Pas encore de recrutement
        • Washington University School of Medicine
        • Chercheur principal:
          • Amy Zhou
        • Contact:
    • Montana
      • Billings, Montana, États-Unis, 59101
        • Pas encore de recrutement
        • St. Vincent Regional Hospital Cancer Centers
        • Chercheur principal:
          • Patrick Cobb
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, États-Unis, 87102
        • Pas encore de recrutement
        • University of New Mexico Comprehensive Cancer Center
        • Chercheur principal:
          • Ala Ebaid
        • Contact:
    • New York
      • New York, New York, États-Unis, 10029
        • Pas encore de recrutement
        • Icahn School of Medicine at Mount Sinai
        • Chercheur principal:
          • John Mascarenhas
        • Contact:
      • New York, New York, États-Unis, 10021
        • Pas encore de recrutement
        • Memorial Sloan Kettering Cancer Center
        • Chercheur principal:
          • Brian Chernak
        • Contact:
    • North Carolina
      • Durham, North Carolina, États-Unis, 27705
        • Pas encore de recrutement
        • Duke Blood Cancer Center
        • Chercheur principal:
          • Lindsay Rein
        • Contact:
      • Winston-Salem, North Carolina, États-Unis, 27103
        • Pas encore de recrutement
        • Novant Health
        • Chercheur principal:
          • James Dugan
        • Contact:
    • Ohio
      • Cleveland, Ohio, États-Unis, 44195
        • Pas encore de recrutement
        • Cleveland Clinic
        • Chercheur principal:
          • Aaron Gerds
        • Contact:
          • Site Contact
          • Numéro de téléphone: 772-297-3057
          • E-mail: gerdsa@ccf.org
    • Oregon
      • Portland, Oregon, États-Unis, 97239
        • Pas encore de recrutement
        • Oregon Health and Science University
        • Contact:
        • Chercheur principal:
          • Jessica Stempel
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19107
        • Pas encore de recrutement
        • Thomas Jefferson University
        • Chercheur principal:
          • Lindsay Wilde
        • Contact:
      • Pittsburgh, Pennsylvania, États-Unis, 15219
        • Pas encore de recrutement
        • University of Pittsburgh Medical Center
        • Contact:
        • Chercheur principal:
          • James Rossetti
      • Pittsburgh, Pennsylvania, États-Unis, 15224
        • Pas encore de recrutement
        • Allegheny Health Network Cancer Institute - West Penn Hospital Location
        • Chercheur principal:
          • Anna Koget
        • Contact:
    • South Carolina
      • Charleston, South Carolina, États-Unis, 29425
        • Pas encore de recrutement
        • Medical University of South Carolina
        • Chercheur principal:
          • Praneeth Baratam
        • Contact:
    • Tennessee
      • Nashville, Tennessee, États-Unis, 37232-0021
        • Pas encore de recrutement
        • Vanderbilt-Ingram Cancer Center (VICC)-Nashville
        • Chercheur principal:
          • Ashwin Kishtagari
        • Contact:
    • Texas
      • Dallas, Texas, États-Unis, 75246
        • Pas encore de recrutement
        • Baylor University Medical Center
        • Contact:
        • Chercheur principal:
          • Micah Burch
      • Houston, Texas, États-Unis, 77030
        • Pas encore de recrutement
        • MD Anderson Cancer Center
        • Chercheur principal:
          • Prithviraj Bose
        • Contact:
      • Houston, Texas, États-Unis, 77090
        • Recrutement
        • LUMI Research
        • Chercheur principal:
          • David Nguyen
        • Contact:
      • Houston, Texas, États-Unis, 77030
        • Pas encore de recrutement
        • The University of Utah-Huntsman Cancer Institute
        • Chercheur principal:
          • Srinivas Tantravahi
        • Contact:
    • Washington
      • Seattle, Washington, États-Unis, 98109
        • Pas encore de recrutement
        • University of Washington
        • Chercheur principal:
          • Anna Halpern
        • Contact:
          • Site Contact
          • Numéro de téléphone: 206-606-1978
          • E-mail: halpern2@uw.edu

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Aged ≥18 years at the time of signing the informed consent form (ICF).
  2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF.
  3. 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.
  4. Transfusion status as assessed in the 12 weeks immediately preceding randomization classified as Transfusion Dependent: 3 to 8 RBC units over 12 weeks.
  5. 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.
  6. Eastern Cooperative Oncology Group score less than or equal to (≤) 2.

Exclusion Criteria:

  1. Prior treatment with luspatercept, sotatercept, or other transforming growth factor beta inhibitors or activin receptor ligand traps.

  2. Systemic treatment within 28 days before randomization with any of the following:

    1. Androgens (including danazol). Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed.
    2. erythropoiesis-stimulating agents.
    3. granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor.
    4. High dose corticosteroids. Participants on stable chronic steroid doses of prednisone ≤10 mg/day or corticosteroid equivalent for ≥4 weeks are allowed. Other treatments for autoimmune diseases may be allowed upon medical monitor review.
    5. Hydroxyurea.
    6. Immunomodulatory drugs (for example, thalidomide, pomalidomide, or lenalidomide).
    7. Interferon.
    8. Thrombopoietin receptor agonists.
    9. Any investigational drug, including antihemojuvelin antibody. If the half-life of the investigational product is known, the exclusionary period prior to randomization is equal to 5 half-lives of the investigational product or 28 days, whichever is longer.
  3. Initiation of new iron chelation therapy or dose adjustments to existing iron chelation therapy ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed.
  4. Clinically significant anemia that is due to causes other than MF or Janus kinase (JAK) inhibitor therapy (for example, thalassemia, iron deficiency, vitamin B12 and/or folate deficiencies, autoimmune or hemolytic anemia, infections, or any active clinically significant bleeding or sequestration).
  5. Receipt of RBC transfusion for any reason(s) other than underlying MF within 12 weeks before randomization.
  6. Life expectancy <12 months per investigator's judgment.

  7. Clinically significant cardiovascular disease, defined as:

    1. New York Heart Association heart disease Class III or IV;
    2. Fridericia corrected QT interval >500 millisecond (ms) during screening;
    3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening.
  8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimetres of mercury (mmHg) and/or diastolic blood pressure ≥100 mmHg despite adequate treatment.
  9. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.

  10. Prior history of malignancies, other than MF. Participants who are free of other malignant disease for ≥2 years and have completed treatment, including maintenance, are allowed. 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 Tumour, Node, and Metastasis (TNM) staging system);
    5. Early papillary thyroid cancer (stage I [T1-T2, N0, M0]).
  11. History of solid organ or bone marrow transplantation.
  12. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 7 days before randomization. Prophylactic antibiotics and/or antifungals for neutropenia are allowed.
  13. Known positivity for Human Immunodeficiency Virus (HIV), active hepatitis B virus (HBV), or active hepatitis C virus (HCV). Participants without known history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.
  14. Body mass index ≥40 kilograms per square meter (kg/m^2).
  15. Major surgery within 28 days before randomization.
  16. History of allergy/anaphylaxis to recombinant proteins, investigational product, or excipients (refer to the current elritercept investigator's brochure for a list of excipients), or ruxolitinib.

  17. Any of the following local laboratory abnormalities:

    1. Absolute neutrophil count <500/microliter (μL) (0.5×109/ liter (L)).
    2. Platelet count <50,000/μL (50×109/L) or >1,000,000/μL (1000×109/L).
    3. Blasts >5% as assessed in peripheral blood at screening or ≥10% in any historical bone marrow assessments. Participants with isolated transient elevations of peripheral blood blasts may be eligible after discussion between the investigator and medical monitor to confirm the blast count is not indicative of disease progression.
    4. Serum aspartate aminotransferase or alanine aminotransferase ≥3× the upper limit of normal (ULN).
    5. Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin less than (<) 3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review.
    6. Estimated glomerular filtration rate <30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration equation.
    7. Ferritin ≤50 micrograms per liter (μg/L).
    8. Folate ≤2.0 nanograms per milliliter (ng/mL).
    9. Vitamin B12 ≤200 picograms per milliliter (pg/mL).
  18. Ongoing participation in another interventional clinical trial.
  19. Participant is unwilling or, in the opinion of the investigator, the participant is unable to comply with the requirements of the protocol.
  20. Is a person of childbearing potential but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of elritercept or placebo.
  21. Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom, during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.
  22. If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.
  23. For participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Elritercept
Elritercept, SC, injection
Autres noms:
  • TAK-226
Comparateur placebo: 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.
Médicament: Elritercept
Elritercept, SC, injection
Autres noms:
  • TAK-226
Médicament: Placebo
Elritercept-matching placebo

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of Participants Who Are Red Blood Cell-Transfusion Independent (RBC-TI) for Any Consecutive Greater Than or Equal to (≥) 12-Week Period During the 36-Week Double-Blinded Treatment Period
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Proportion of Participants Who Achieve ≥50 Percent (%) Reduction in RBC Transfusion Burden From Baseline Over Any Consecutive 12-Week Period
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Who Are RBC-TI for Any Consecutive ≥16-Week Period
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Who Are RBC-TI for Any Consecutive ≥12-Week Period With Concurrent Mean Hemoglobin (Hgb) Increase ≥1.5 Grams per Deciliter (g/dL) From Baseline
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Who Are RBC-TI for Any Consecutive ≥24-Week Period
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Who Are RBC-TI for Any Consecutive ≥12-Week Period With Concurrent Mean Hgb Increase of ≥1.0 g/dL and ≥2.0 g/dL From Baseline
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Who Are RBC-TI for Any Consecutive 16- or 24-Week Period With a Concurrent Mean Hgb Increase of ≥1.0 g/dL, ≥1.5 g/dL, and ≥2.0 g/dL From Baseline
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Maximum Duration of RBC-TI for Participants Who Achieved RBC-TI for a Consecutive ≥12 Weeks
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Maximum Duration of RBC-TI With Concurrent Mean Hgb Increase of ≥1.5 g/dL for Participants Who Achieved Consecutive ≥12 Weeks RBC-TI With Concurrent Mean Hgb Increase of ≥1.5 g/dL
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Time to Onset of Anemia Response
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Time to onset of anemia response is defined as the duration between the date of randomization and the date participant first achieved anemia response status. Anemia response is evaluated as: achievement of RBC-TI for any consecutive ≥12-week, ≥16-week, or ≥24-week period or ≥50% reduction in red blood cell transfusion burden from baseline over any consecutive 12 weeks.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Fatigue 7a T-Score at Week 36
Délai: Baseline, Week 36
PROMIS Short Form v1.0 - Fatigue 7a is a 7-item, patient-reported measure designed to assess fatigue symptoms and impact over the past 7 days. Response options are on a 5-point scale from never (1) to always (5). Raw scores are computed by summing responses to all 7 items and then converted to a standardized T-score on a scale from 0 to 100 with a mean of 50 and SD of 10 with higher scores representing worse fatigue. T-scores can be produced using a conversion table available from the instrument developer or using response pattern scoring performed by the Health Measures Scoring Service.
Baseline, Week 36
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue Scale Score at Week 36
Délai: Baseline, Week 36
EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participants with cancer. The questionnaire's items are divided among 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social), 3 multi-item scales measuring symptoms (fatigue, nausea/vomiting, and pain), 6 items measuring symptoms (dyspnea, insomnia, appetite loss, constipation, and diarrhea) as well as financial difficulties, and a 2-item scale measuring global health status (GHS))/quality of life (QoL). Items included in GHS/QoL scale use a 7-point response metric ranging from very poor to excellent, while other items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning, GHS/QoL, or worse symptomatology.
Baseline, Week 36
Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in PROMIS Short Form v1.0 - Fatigue 7a T-score
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
PROMIS Short Form v1.0 - Fatigue 7a is a 7-item, patient-reported measure designed to assess fatigue symptoms and impact over the past 7 days. Response options are on a 5-point scale from never (1) to always (5). Raw scores are computed by summing responses to all 7 items and then converted to a standardized T-score on a scale from 0 to 100 with a mean of 50 and SD of 10 with higher scores representing worse fatigue. T-scores can be produced using a conversion table available from the instrument developer or using response pattern scoring performed by the Health Measures Scoring Service. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Time to Meaningful Improvement and Meaningful Deterioration in PROMIS Short Form v1.0 - Fatigue 7a T-Score From Baseline
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
PROMIS Short Form v1.0 - Fatigue 7a is a 7-item, patient-reported measure designed to assess fatigue symptoms and impact over the past 7 days. Response options are on a 5-point scale from never (1) to always (5). Raw scores are computed by summing responses to all 7 items and then converted to a standardized T-score on a scale from 0 to 100 with a mean of 50 and SD of 10 with higher scores representing worse fatigue. T-scores can be produced using a conversion table available from the instrument developer or using response pattern scoring performed by the Health Measures Scoring Service. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Fatigue Scale Score
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The items are divided among 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social), 3 multi-item scales measuring symptoms (fatigue, nausea/vomiting, pain), 6 items measuring symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) as well as financial difficulties, and a 2-item scale measuring GHS and QoL. Items included in GHS/QoL scale use a 7-point response metric ranging from very poor to excellent, while other items use a 4-point response metric, categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning, better GHS/QoL, or worse symptomatology. Score cutoffs to define meaningful improvement/deterioration to be determined before primary analysis.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Time to Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Fatigue Scale Score From Baseline
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The items are divided among 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, social), 3 multi-item scales measuring symptoms (fatigue, nausea/vomiting, pain), 6 items measuring symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) as well as financial difficulties, and a 2-item scale measuring GHS and QoL. Items included in GHS/QoL scale use a 7-point response metric ranging from very poor to excellent, while other items use a 4-point response metric, categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning, better GHS/QoL, or worse symptomatology. Score cutoffs to define meaningful improvement/deterioration to be determined before primary analysis.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Mean Changes From Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 7-Item Total Symptom Score at Week 36
Délai: Baseline, Week 36
MFSAF v4.0 is a unidimensional measure assessing 7 core MF symptoms: fatigue, night sweats, itching, abdominal discomfort, pain under ribs, early satiety, and bone pain. The questionnaire asks participants to rate each symptom at its worst during the past 7 days on a 0 to 10 numeric rating scale ranging from absent (0) to worst imaginable (10). The Total Symptom Score (TSS) is calculated as the average of the 7 individual item responses multiplied by 7, yielding a score range of 0 to 70 with higher scores representing worse symptom severity.
Baseline, Week 36
Proportion of Participants Achieving Confirmed 50% Reduction in MFSAF v4.0 Total Symptom Score (TSS50)
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
MFSAF v4.0 is a unidimensional measure assessing 7 core MF symptoms: fatigue, night sweats, itching, abdominal discomfort, pain under ribs, early satiety, and bone pain. The questionnaire asks participants to rate each symptom at its worst during the past 7 days on a 0 to 10 numeric rating scale ranging from absent (0) to worst imaginable (10). The TSS is calculated as the average of the 7 individual item responses multiplied by 7, yielding a score range of 0 to 70 with higher scores representing worse symptom severity.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Time to Symptom Response in MFSAF TSS50 From Baseline
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
MFSAF v4.0 is a unidimensional measure assessing 7 core MF symptoms: fatigue, night sweats, itching, abdominal discomfort, pain under ribs, early satiety, and bone pain. The questionnaire asks participants to rate each symptom at its worst during the past 7 days on a 0 to 10 numeric rating scale ranging from absent (0) to worst imaginable (10). The TSS is calculated as the average of the 7 individual item responses multiplied by 7, yielding a score range of 0 to 70 with higher scores representing worse symptom severity.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Mean Change From Baseline EORTC QLQ-C30 Physical Functioning Scale Score at Week 36
Délai: Baseline, Week 36
EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The questionnaire's items include 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social). These items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning.
Baseline, Week 36
Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Physical Functioning Scale Score
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The questionnaire's items include 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social). These items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Time to Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Physical Functioning Scale Score From Baseline
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The questionnaire's items include 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social). These items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants With Platelet Response During the 36-Week Double-Blinded Treatment Period
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Platelet response includes a mean increase of ≥30×10^9/ liter (L) from baseline, a >50% increase from baseline with a count ≥50×10^9/L, and conversion from <100 to ≥100×10^9/L, each sustained for ≥12 weeks.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Achieving Spleen Volume Reduction (SVR) From Baseline as Measured by Computed Tomography/Magnetic Resonance Imaging (CT/MRI) During the 36-Week Double-Blinded Treatment Period
Délai: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of participants achieving SVR of ≥10%, ≥25%, or ≥35% will be presented for this outcome measure.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Who Develop Accelerated Phase (AP) MF
Délai: Up to approximately 7 years
Up to approximately 7 years
Time to Progression in Participants Who Develop AP MF
Délai: Up to approximately 7 years
Up to approximately 7 years
Proportion of Participants Who Develop Blast Phase (BP) MF
Délai: Up to approximately 7 years
Up to approximately 7 years
Time to Progression in Participants Who Develop BP MF
Délai: Up to approximately 7 years
Up to approximately 7 years
Plasma Concentration-Time Data for Participants Treated With Elritercept
Délai: At multiple time points from Cycle 1 Day 1 (each cycle is 28 days) up to approximately 7 years
At multiple time points from Cycle 1 Day 1 (each cycle is 28 days) up to approximately 7 years
Proportion of Participants Treated With Elritercept who Have Antidrug Antibodies
Délai: At multiple time points from Cycle 1 Day 1 (each cycle is 28 days) up to approximately 7 years
At multiple time points from Cycle 1 Day 1 (each cycle is 28 days) up to approximately 7 years
Overall Survival (OS)
Délai: From randomization to 7 years
OS is defined as the time from randomization to the date of death due to any cause.
From randomization to 7 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Takeda

Les enquêteurs

  • Directeur d'études: Study Director, Takeda

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

2 septembre 2026

Achèvement primaire (Estimé)

7 décembre 2029

Achèvement de l'étude (Estimé)

30 mars 2034

Dates d'inscription aux études

Première soumission

29 mai 2026

Première soumission répondant aux critères de contrôle qualité

29 mai 2026

Première publication (Réel)

3 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • TAK-226-3002
  • 2026-525660-17-00 (Ctis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Critères d'accès au partage IPD

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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