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

2026年8月20日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

324

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 以色列
      • Haifa、以色列、3436212
        • 尚未招聘
        • Carmel Medical Center
        • 首席研究员：
          • Elena Mishchenko
        • 接触：
      • Jerusalem、以色列、9112001
        • 尚未招聘
        • Hadassah Medical Organization, Hadassah Medical Center, Ein-
        • 首席研究员：
          • David Lavie
        • 接触：
      • Petah Tikva、以色列、4941492
        • 尚未招聘
        • Rabin Medical Center
        • 接触：
        • 首席研究员：
          • Adi Shacham-Abulafia
    • North
      • Haifa、North、以色列、3109601
        • 尚未招聘
        • Rambam Health Care Campus
        • 接触：
        • 首席研究员：
          • Inna Tzoran
    • TLV
      • Tel Aviv、TLV、以色列、64239
        • 尚未招聘
        • The Tel Aviv Sourasky Medical Center
        • 首席研究员：
          • Ilya Kirgner
        • 接触：
  • 保加利亚
      • Pleven、保加利亚、5800
        • 尚未招聘
        • UMHAT 'Dr. Georgi Stranski', EAD
        • 接触：
        • 首席研究员：
          • Vanya Slavcheva-Popova
      • Plovdiv、保加利亚、4002
        • 尚未招聘
        • Dr. Pencho Georgiev - Outpatient Center
        • 首席研究员：
          • Pencho Georgiev
        • 接触：
      • Sofia、保加利亚、1431
        • 尚未招聘
        • UMHAT Sv. Ivan Rilski
        • 首席研究员：
          • Atanas Radinoff
        • 接触：
      • Sofia、保加利亚、1797
        • 尚未招聘
        • Specialized Hospital for Active Treatment of Haematological Diseases - Sofia
        • 首席研究员：
          • Martin Donchev
        • 接触：
  • 加拿大
    • Ontario
      • Hamilton、Ontario、加拿大、L8V 5C2
        • 尚未招聘
        • Juravinski Cancer Centre
        • 首席研究员：
          • Hillis Christopher
        • 接触：
      • Toronto、Ontario、加拿大、M5G 2M9
        • 尚未招聘
        • Princess Margaret Cancer Centre
        • 接触：
        • 首席研究员：
          • Dawn Maze
    • Quebec
      • Montreal、Quebec、加拿大、H4A 3J1
        • 尚未招聘
        • McGill University Health Center
        • 首席研究员：
          • Jonathan How
        • 接触：
      • Montreal、Quebec、加拿大、H3T1E2
        • 尚未招聘
        • Jewish General Hospital
        • 首席研究员：
          • Shireen Sirhan
        • 接触：
  • 匈牙利
    • HB
      • Debrecen、HB、匈牙利、4032
        • 尚未招聘
        • Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika
        • 首席研究员：
          • Arpad Illes
        • 接触：
    • Komarom-Esztergom VArmegye
      • Tatabánya、Komarom-Esztergom VArmegye、匈牙利、2800
        • 尚未招聘
        • Komárom-Esztergom Vármegyei Szent Borbála Kórház
        • 首席研究员：
          • Zsofia Simon
        • 接触：
  • 印度
      • Delhi、印度、201012
        • 尚未招聘
        • Max Super Specialty Hospital
        • 首席研究员：
          • Rayaz Ahmed
        • 接触：
    • Haryana
      • Gurgaon、Haryana、印度、122001
        • 尚未招聘
        • Medanta- The Medicity- Gurugram
        • 首席研究员：
          • Nitin Sood
        • 接触：
    • Kerala
      • Kochi、Kerala、印度、682041
        • 尚未招聘
        • Amrita Institute of Medical Sciences
        • 接触：
        • 首席研究员：
          • Neeraj Sidharthan
      • Thiruvananthapuram、Kerala、印度、695011
        • 尚未招聘
        • Regional Cancer Centre
        • 接触：
        • 首席研究员：
          • Sungeeth Thambi
    • Maharashtra
      • Pune、Maharashtra、印度、411004
        • 尚未招聘
        • Sahyadri Super Speciality Hospital Deccan
        • 接触：
        • 首席研究员：
          • Shashikant Janardhan Apte
    • NEW Delhi
      • Rohini、NEW Delhi、印度、110085
        • 尚未招聘
        • Rajiv Gandhi Cancer Institute And Research Centre
        • 首席研究员：
          • Dinesh Bhurani
        • 接触：
    • National Capital Territory of Delhi
      • New Delhi、National Capital Territory of Delhi、印度、110029
        • 尚未招聘
        • All India Institute of Medical Science
        • 接触：
        • 首席研究员：
          • Ranjit Sahoo
    • Tamil Nadu
      • Chennai、Tamil Nadu、印度、382424
        • 尚未招聘
        • Apollo Specialty Hospitals
        • 首席研究员：
          • Velu Nair
        • 接触：
    • Telangana
      • Hyderabad、Telangana、印度、500096
        • 尚未招聘
        • Apollo Hospital Hyderabad
        • 接触：
        • 首席研究员：
          • Padmaja Lokireddy
    • West Bengal
      • Kolkata、West Bengal、印度、700 160
        • 尚未招聘
        • Tata Medical Center, Kolkata
        • 首席研究员：
          • Arijit Nag
        • 接触：
  • 台湾
      • Kaohsiung City、台湾
        • 尚未招聘
        • Kaohsiung Medical University Hospital
        • 首席研究员：
          • Yi-Chang Liu
        • 接触：
      • Taichung、台湾、40705
        • 尚未招聘
        • Taichung Veterans General Hospital
        • 接触：
        • 首席研究员：
          • Tsung Chih Chen
      • Tainan、台湾、70403
        • 尚未招聘
        • National Cheng Kung University Hospital
        • 首席研究员：
          • Tsai-Yun Chen
        • 接触：
    • Beitou
      • Taipei、Beitou、台湾、11217
        • 尚未招聘
        • Taipei Veterans General Hospital
        • 首席研究员：
          • Chih-Cheng Chen
        • 接触：
    • Taiwan (r.o.c.)
      • Taipei、Taiwan (r.o.c.)、台湾、100
        • 尚未招聘
        • National Taiwan University Hospital
        • 首席研究员：
          • Hsin-An Hou
        • 接触：
  • 哥伦比亚
    • Antioquia
      • Medellín、Antioquia、哥伦比亚、0000000
        • 尚未招聘
        • Hospital Pablo Tobon Uribe
        • 接触：
        • 首席研究员：
          • Kenny Galvez
    • Atlántico
      • Barranquilla、Atlántico、哥伦比亚、080002
        • 尚未招聘
        • Clinica General del Norte De Barranquilla
        • 接触：
        • 首席研究员：
          • Arturo Guzman
    • Bogota D.C.
      • Bogotá、Bogota D.C.、哥伦比亚、110121
        • 尚未招聘
        • Los Cobos Medical Center
        • 接触：
        • 首席研究员：
          • Jheremy Reyes
    • Cundinamarca
      • Bogota、Cundinamarca、哥伦比亚、11011
        • 尚未招聘
        • Funcacion santa Fe De Bogota
        • 接触：
        • 首席研究员：
          • Claudia Agudelo
  • 土耳其（türkiye）
      • Istanbul、土耳其（türkiye）、34381
        • 尚未招聘
        • Istanbul Florence Nightingale Hospital
        • 接触：
        • 首席研究员：
          • Omur Sevindik
      • Istanbul、土耳其（türkiye）、34303
        • 尚未招聘
        • Istanbul University-CerrahpaAYa, CerrahpaAYa Faculty of Medicine
        • 接触：
        • 首席研究员：
          • Ahmet Emre Eskazan
    • Ankara
      • Çankaya、Ankara、土耳其（türkiye）、06800
        • 尚未招聘
        • Ankara Bilkent City Hospital
        • 接触：
        • 首席研究员：
          • Marve Pamukcuoglu
    • Mezitli
      • Mersin、Mezitli、土耳其（türkiye）、33000
        • 尚未招聘
        • VM Medical Park Mersin Hospital
        • 首席研究员：
          • Anil Tombak
        • 接触：
  • 墨西哥
    • Mexic
      • Monterrey、Mexic、墨西哥、64710
        • 尚未招聘
        • Universidad Autonoma de Nuevo Leon
        • 首席研究员：
          • David Gomez Almaguer
        • 接触：
    • Mexico de Mexico
      • Huixquilucan、Mexico de Mexico、墨西哥、52787
        • 尚未招聘
        • Hematologica Alta Especialidad S.C.
        • 接触：
        • 首席研究员：
          • Roberto Ovilla Martinez
    • Oaxaca
      • Oaxaca City、Oaxaca、墨西哥、68000
        • 尚未招聘
        • OSMO - Oaxaca Site Management Organization S.C
        • 接触：
        • 首席研究员：
          • Eva Ramirez Romero
  • 奥地利
      • Linz、奥地利、4020
    • A
      • Vienna、A、奥地利、1090
        • 尚未招聘
        • Medizinische Universitat Wien (Medical University of Vienna - Austria)
        • 接触：
        • 首席研究员：
          • Maria-Theresa Krauth
    • Tyrol
      • Innsbruck、Tyrol、奥地利、6020
        • 尚未招聘
        • Medizinische Universität Innsbruck
        • 接触：
        • 首席研究员：
          • Dominik Wolf
    • Upper Austria
      • Wels、Upper Austria、奥地利、4600
        • 尚未招聘
        • Klinikum Wels-Grieskirchen
        • 首席研究员：
          • Sonja Heibl
        • 接触：
  • 巴西
      • São Paulo、巴西、01323-900
        • 尚未招聘
        • Portuguese Charity of Sao Paulo
        • 首席研究员：
          • Phillip Scheinberg
        • 接触：
    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、90610-000
        • 尚未招聘
        • Hospital Sao Lucas da PUCRS
        • 首席研究员：
          • Mariza Schaan
        • 接触：
      • Porto Alegre、Rio Grande do Sul、巴西、90035-903
        • 尚未招聘
        • Porto Alegre Clinical Hospital (HCPA)
        • 首席研究员：
          • Laura Maria Fogliatto
        • 接触：
      • Porto Alegre、Rio Grande do Sul、巴西、90110-270
        • 尚未招聘
        • Hospital Mae De Deus - Integrated Oncology Center
        • 首席研究员：
          • Marcelo Capra
        • 接触：
    • Rio de Janeiro
      • Rio de Janeiro、Rio de Janeiro、巴西、22061080
        • 尚未招聘
        • Centro de Ensino, Pesquisa e Inovacao do Hospital Sao Lucas (CEPIN HSL RJ / Rede Americas)
        • 接触：
        • 首席研究员：
          • Cristiane Solza
    • Santa Catarina
      • Florianópolis、Santa Catarina、巴西、88020-210
        • 尚未招聘
        • Grupo Elora Pesquisa Clinica
        • 接触：
        • 首席研究员：
          • Jaisson Bortolini
      • Joinville、Santa Catarina、巴西、89201-260
        • 尚未招聘
        • Centro de Hematologia e Oncologia (CHO)
        • 首席研究员：
          • Marcelo Pitombeira de Lacerda
        • 接触：
    • São Paulo
      • Jaú、São Paulo、巴西、17210-080
  • 希腊
    • Ahaia
      • Pátrai、Ahaia、希腊、264 43
        • 尚未招聘
        • Olympion General Clinic & Rehabilitation Center
        • 首席研究员：
          • Argiris Symeonidis
        • 接触：
    • Attica
      • Athens、Attica、希腊、11528
        • 尚未招聘
        • Alexandra General Hospital of Athens
        • 首席研究员：
          • Meletios-Athanasios Dimopoulos
        • 接触：
      • Athens、Attica、希腊、11526
        • 尚未招聘
        • Laiko General Hospital of Athens
        • 首席研究员：
          • Theodoros Vassilakopoulos
        • 接触：
      • Athens、Attica、希腊、11527
        • 尚未招聘
        • General Hospital
        • 首席研究员：
          • Panagiotis Diamantopoulos
        • 接触：
    • Crete
      • Heraklion、Crete、希腊、70013
        • 尚未招聘
        • University of Crete
        • 接触：
        • 首席研究员：
          • Nikolaos Sousos
    • Macedonia
      • Thessaloniki、Macedonia、希腊、54642
        • 尚未招聘
        • Ippokrateion Hospital of Thessaloniki
        • 接触：
        • 首席研究员：
          • Eleni Gavriilaki
  • 德国
      • Berlin、德国、10715
    • Baden-Wurttemberg
      • Freiburg im Breisgau、Baden-Wurttemberg、德国、79106
        • 尚未招聘
        • Universitaetsklinikum Freiburg
        • 接触：
        • 首席研究员：
          • Heiko Becker
      • Heidelberg、Baden-Wurttemberg、德国、69120
        • 尚未招聘
        • Universitaetsklinikum Heidelberg (UKHD)
        • 接触：
        • 首席研究员：
          • Tim Sauer
      • Mutlangen、Baden-Wurttemberg、德国、73557
    • North Rhine-Westphalia
      • Minden、North Rhine-Westphalia、德国、32429
        • 尚未招聘
        • Muehlenkreiskliniken AoeR-Johannes Wesling Klinikum Minden - Universitaetsklinik fuer Neurologie und Neurogeriatrie
        • 首席研究员：
          • Martin Griesshammer
        • 接触：
    • Rhineland-Palatinate
      • Koblenz、Rhineland-Palatinate、德国、56068
        • 尚未招聘
        • Institut fur Versorgungsforschung in der Onkologie GbR
        • 接触：
        • 首席研究员：
          • Cristoph Lutz
    • Saxony
      • Chemnitz、Saxony、德国、9116
        • 尚未招聘
        • Klinikum Chemnitz GmbH
        • 首席研究员：
          • Mathias Hanel
        • 接触：
    • Saxony-Anhalt
      • Halle、Saxony-Anhalt、德国、06120
        • 尚未招聘
        • University Hospital Halle (Saale)
        • 首席研究员：
          • Haifa Kathrin Al-Ali
        • 接触：
    • Thuringia
      • Jena、Thuringia、德国、7743
        • 尚未招聘
        • Universitaetsklinikum Jena
        • 首席研究员：
          • Carl Crodel
        • 接触：
  • 意大利
      • Ancona、意大利、60121
        • 尚未招聘
        • Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica
        • 接触：
        • 首席研究员：
          • Erika Morsia
      • Catania、意大利、95124
        • 尚未招聘
        • Policlinico Universitario di Catania
        • 首席研究员：
          • Giuseppe Palumbo
        • 接触：
      • Florence、意大利、50134
        • 尚未招聘
        • Azienda Ospedaliera Universitaria Careggi
        • 首席研究员：
          • Alessandro Maria Vannucchi
        • 接触：
      • Torino、意大利、10126
        • 尚未招聘
        • AOU Citta della Salute e della Scienza di Torino
        • 接触：
        • 首席研究员：
          • Benevolo Giulia
      • Udine、意大利、33100
        • 尚未招聘
        • Azienda Sanitaria Universitaria Friuli Centrale
        • 首席研究员：
          • Mario Tiribelli
        • 接触：
    • BO
      • Bologna、BO、意大利、40138
        • 尚未招聘
        • IRCCS - AOU di Bologna - Sant Orsola Malpighi
        • 首席研究员：
          • FRANCESCA PALANDRI
        • 接触：
    • Ferrara
      • Cona、Ferrara、意大利、44124
        • 尚未招聘
        • Universitaria di Ferrara Azienda Ospedaliero
        • 接触：
        • 首席研究员：
          • Giuseppe Auteri
    • Forli-Cesena
      • Meldola、Forli-Cesena、意大利、47014
        • 尚未招聘
        • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l
        • 首席研究员：
          • Alessandro Lucchesi
        • 接触：
    • Lazio
      • Rome、Lazio、意大利、00161
        • 尚未招聘
        • Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
        • 首席研究员：
          • Massimo Breccia
        • 接触：
      • Rome、Lazio、意大利、144
        • 尚未招聘
        • Ospedale S Eugenio
        • 首席研究员：
          • Elisabetta Abruzzese
        • 接触：
    • MI
      • Milan、MI、意大利、20122
        • 尚未招聘
        • Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano
        • 首席研究员：
          • Francesco Passamonti
        • 接触：
    • RM
      • Rome、RM、意大利、00168
        • 尚未招聘
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • 接触：
        • 首席研究员：
          • Elena Rossi
  • 捷克语
      • Prague、捷克语、134 00
        • 尚未招聘
        • Fakultni nemocnice Kralovske Vinohrady
        • 首席研究员：
          • Olga Cerna
        • 接触：
    • CZ
      • Hradec Králové、CZ、捷克语、50005
        • 尚未招聘
        • Fakultni nemocnice Hradec Kralove
        • 首席研究员：
          • Petra Belohlavkova
        • 接触：
      • Prague、CZ、捷克语、12808
        • 尚未招聘
        • Vseobecna fakultni nemocnice Praha
        • 首席研究员：
          • Anna Jonasova
        • 接触：
    • Czech Republic
      • Brno、Czech Republic、捷克语、625 00
        • 尚未招聘
        • Masaryk University Hospital Brno, Department of Internal Medicine, Hematology and Oncology
        • 接触：
        • 首席研究员：
          • Barbora Weinbergerova
  • 日本
    • Chiba
      • Chiba、Chiba、日本、260-8717
        • 尚未招聘
        • Chiba Cancer Center
        • 首席研究员：
          • Masahiro Takeuchi
        • 接触：
    • Ehime
      • Toon-shi、Ehime、日本、791-0295
        • 尚未招聘
        • Ehime University Hospital
        • 接触：
        • 首席研究员：
          • Katsuto Takenaka
    • Hyōgo
      • Kobe、Hyōgo、日本、650-0047
        • 尚未招聘
        • Kobe City Medical Center General Hospital
        • 接触：
          • Site Contact
          • 电话号码：78-302-4321
        • 首席研究员：
          • Yuya Nagai
    • Ibaraki
      • Hitachi、Ibaraki、日本、317-0077
    • Mie-ken
      • Tsu、Mie-ken、日本、514-8507
        • 尚未招聘
        • Mie University Hospital
        • 接触：
          • Site Contact
          • 电话号码：81(0)59-232-1111
        • 首席研究员：
          • Yuka Sugimoto
    • Miyazaki
      • Miyazaki、Miyazaki、日本、889-1692
        • 尚未招聘
        • University of Miyazaki Hospital
        • 接触：
          • Site Contact
          • 电话号码：81-985-85-1510
        • 首席研究员：
          • Kazuya Shimoda
    • Tokyo
      • Bunkyo-Ku、Tokyo、日本、113-8677
        • 尚未招聘
        • Tokyo Metropolitan Komagome Hospital
        • 接触：
        • 首席研究员：
          • Noriko Doki
    • Yamanashi
      • Chuo-shi、Yamanashi、日本、409-3898
        • 尚未招聘
        • University of Yamanashi Hospital
        • 首席研究员：
          • Keita Kirito
        • 接触：
  • 智利
    • Biobio
      • Concepción、Biobio、智利、4030000
        • 尚未招聘
        • Hospital Cliniico Regional de Concepcion Dr
        • 首席研究员：
          • Monica Romero
        • 接触：
    • Coquimbo Region
      • La Serena、Coquimbo Region、智利、01697
        • 尚未招聘
        • IC La Serena Research
        • 首席研究员：
          • Cleiden Villegas
        • 接触：
    • La Florida
      • Santiago、La Florida、智利、8241479
        • 尚未招聘
        • Icegclinic
        • 接触：
        • 首席研究员：
          • Carlos Avendano
    • Santiago Metropolitan
      • Las Condes、Santiago Metropolitan、智利、7560908
        • 尚未招聘
        • Immunocel
        • 首席研究员：
          • Alejandro Berkovits
        • 接触：
      • Santiago、Santiago Metropolitan、智利、7850000
        • 尚未招聘
        • Centro de Oncologia de Precision
        • 接触：
        • 首席研究员：
          • Ignacio Corvalan
  • 比利时
      • Antwerp、比利时、2030
        • 尚未招聘
        • Ziekenhuis aan de Stroom-Cadix
        • 首席研究员：
          • Nikki Granacher
        • 接触：
      • Yvoir、比利时、5530
    • Hainaut
    • Vlaams-Brabant
      • Leuven、Vlaams-Brabant、比利时、3000
        • 尚未招聘
        • UZ Leuven
        • 首席研究员：
          • Timothy Devos
        • 接触：
    • West-Vlaanderen
      • Roeselare、West-Vlaanderen、比利时、8800
        • 尚未招聘
        • AZ Delta
        • 首席研究员：
          • Lien Deleu
        • 接触：
  • 沙特阿拉伯
      • Riyadh、沙特阿拉伯、12372
        • 尚未招聘
        • King Khalid University Hospital
        • 接触：
        • 首席研究员：
          • Musa Alzahrani
      • Riyadh、沙特阿拉伯、11211
        • 尚未招聘
        • King Faisal Specialist Hospital & Research Centre Riyadh
        • 接触：
        • 首席研究员：
          • Marwan Shaheen
  • 法国
    • Alpes Maritimes
      • Nice、Alpes Maritimes、法国、6002
        • 尚未招聘
        • Chu De Nice
        • 首席研究员：
          • Michael Loschi
        • 接触：
    • Auvergne-Rhône-Alpes
      • Pierre-Bénite、Auvergne-Rhône-Alpes、法国、69495
        • 尚未招聘
        • Centre Hospitalier LYON SUD
        • 首席研究员：
          • Vincent Alcazer
        • 接触：
    • Bas Rhin
      • Strasbourg、Bas Rhin、法国、67200
        • 尚未招聘
        • CHU de Strasbourg
        • 接触：
        • 首席研究员：
          • Shanti Ame
    • Bouches-du-Rhone
      • Marseille、Bouches-du-Rhone、法国、13009
        • 尚未招聘
        • Institut Paoli Calmettes
        • 接触：
        • 首席研究员：
          • Jerome Rey
    • Finistere
      • Brest、Finistere、法国、29609
        • 尚未招聘
        • Centre Hospitalier Regional Universitaire Brest Hopital Morvan
        • 首席研究员：
          • Jean-Christophe Ianotto
        • 接触：
    • Gironde
      • Pessac、Gironde、法国、33600
    • Nord
      • Lille、Nord、法国、59037
        • 尚未招聘
        • Centre Hospitalier Regional Universitaire de Lille
        • 接触：
        • 首席研究员：
          • Mathieu Wemeau
    • Paris
      • Paris、Paris、法国、75015
        • 尚未招聘
        • Assistance Publique Hopitaux De Paris
        • 接触：
        • 首席研究员：
          • Lina Benajiba
    • Vienne
  • 波兰
    • Greater Poland Voivodeship
      • Poznan、Greater Poland Voivodeship、波兰、60-192
        • 尚未招聘
        • Pratia Poznań
        • 首席研究员：
          • Anna Hoppe
        • 接触：
    • Kuyavian-Pomeranian Voivodeship
      • Torun、Kuyavian-Pomeranian Voivodeship、波兰、87-100
        • 尚未招聘
        • Wojewodzki Szpital Zespolony Im L Rydygiera
        • 首席研究员：
          • Dominik Chraniuk
        • 接触：
    • Masovian Voivodeship
      • Warsaw、Masovian Voivodeship、波兰、02-172
        • 尚未招聘
        • MTZ Clinical Research Powered by PRATIA
        • 首席研究员：
          • Krzysztof Madry
        • 接触：
    • Silesian Voivodeship
      • Chorzów、Silesian Voivodeship、波兰、41-500
        • 尚未招聘
        • Zespol Szpitali Miejskich w Chorzowie
        • 接触：
        • 首席研究员：
          • Piotr Malecki
      • Katowice、Silesian Voivodeship、波兰、40-519
        • 尚未招聘
        • Pratia Oncology Katowice
        • 首席研究员：
          • Sebastian Grosicki
        • 接触：
    • Łódź Voivodeship
      • Lodz、Łódź Voivodeship、波兰、93-513
        • 尚未招聘
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Hematologii
        • 接触：
        • 首席研究员：
          • Joanna Gora-Tybor
  • 澳大利亚
    • Adelaide, SA
      • Bedford Park、Adelaide, SA、澳大利亚、5042
        • 尚未招聘
        • Flinders Medical Centre
        • 首席研究员：
          • David Ross
        • 接触：
    • New South Wales
      • Coffs Harbour、New South Wales、澳大利亚、2450
        • 尚未招聘
        • Mid North Coast Cancer Institute (MNCCI)
        • 首席研究员：
          • Kyle Crassini
        • 接触：
      • Cudgen、New South Wales、澳大利亚、2487
        • 尚未招聘
        • Tweed Valley Hospital
        • 首席研究员：
          • Steven Wong
        • 接触：
      • Kogarah、New South Wales、澳大利亚、2217
        • 尚未招聘
        • South Eastern Sydney Local Health District
        • 接触：
        • 首席研究员：
          • Sundreswran (Sundra) Ramanathan
  • 爱尔兰
      • Cork、爱尔兰、T12 DC4A
        • 尚未招聘
        • Cork University Hospital
        • 接触：
        • 首席研究员：
          • Clodagh Keohane
      • Dublin、爱尔兰、D08 NHY1
        • 尚未招聘
        • St James's Hospital
        • 首席研究员：
          • Catherine Flynn
        • 接触：
      • Dublin、爱尔兰、D15 W8Y7
        • 尚未招聘
        • Mater Misericordiae University Hospital
        • 首席研究员：
          • Su Maung
        • 接触：
      • Galway、爱尔兰、H91YR71
        • 尚未招聘
        • University Hospital Galway
        • 首席研究员：
          • Janusz Krawczyk
        • 接触：
  • 瑞典
      • Stockholm、瑞典、14186
        • 尚未招聘
        • Karolinska University Hospital
        • 首席研究员：
          • Anne-Marie Landtblom
        • 接触：
      • Örebro、瑞典、70185
        • 尚未招聘
        • Örebro University Hospital
        • 接触：
        • 首席研究员：
          • Erik Ahlstrand
  • 罗马尼亚
      • Bucharest、罗马尼亚、20125
        • 尚未招聘
        • Colentina Clinical Hospital
        • 首席研究员：
          • Mihaela Andreescu
        • 接触：
      • Timișoara、罗马尼亚、300700
        • 尚未招聘
        • Spitalul Clinic Municipal de Urgenta Timisoara
        • 接触：
        • 首席研究员：
          • Ioana Ionita
    • CJ
      • Cluj-Napoca、CJ、罗马尼亚、400124
        • 尚未招聘
        • Institutul Oncologic Prof. Dr. Ion Chiricuta
        • 首席研究员：
          • Ciprian Tomuleasa
        • 接触：
    • Dolj
      • Craiova、Dolj、罗马尼亚、200143
        • 尚未招聘
        • Spitalul Municipal Filantropia Craiova
        • 首席研究员：
          • Luminita Ocroteala
        • 接触：
  • 美国
    • Arizona
      • Gilbert、Arizona、美国、85234
        • 尚未招聘
        • Banner MD Anderson Cancer Center
        • 首席研究员：
          • Mark Faber
        • 接触：
    • California
      • Glendale、California、美国、91204
        • 尚未招聘
        • Los Angeles Cancer Network
        • 接触：
        • 首席研究员：
          • Saro Kasparian
      • Whittier、California、美国、90603
        • 尚未招聘
        • Cancer and Blood Specialty Clinic
        • 首席研究员：
          • Merrill Shum
        • 接触：
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20007
    • Florida
      • Coral Springs、Florida、美国、33065
        • 招聘中
        • Advanced Research, LLC
        • 首席研究员：
          • Sumit Sawhney
        • 接触：
      • Miami、Florida、美国、33143
      • Orlando、Florida、美国、32804-4648
        • 尚未招聘
        • AdventHealth - Cancer Institute - Orlando
        • 接触：
        • 首席研究员：
          • Ahmed Zakari
      • Tamarac、Florida、美国、33321
        • 尚未招聘
        • Florida Clinical Trials Group
        • 首席研究员：
          • Chintan Gandhi
        • 接触：
      • Tampa、Florida、美国、33612
        • 尚未招聘
        • Moffit Cancer Center
        • 首席研究员：
          • Andrew Kuykendall
        • 接触：
    • Georgia
      • Atlanta、Georgia、美国、30322
    • Massachusetts
      • Boston、Massachusetts、美国、02111
        • 尚未招聘
        • Tufts Medical Center
        • 接触：
        • 首席研究员：
          • Parva Bhatt
    • Missouri
      • St Louis、Missouri、美国、63110
        • 尚未招聘
        • Washington University School of Medicine
        • 首席研究员：
          • Amy Zhou
        • 接触：
    • Montana
      • Billings、Montana、美国、59101
        • 尚未招聘
        • St. Vincent Regional Hospital Cancer Centers
        • 首席研究员：
          • Patrick Cobb
        • 接触：
    • New Mexico
      • Albuquerque、New Mexico、美国、87102
        • 尚未招聘
        • University of New Mexico Comprehensive Cancer Center
        • 首席研究员：
          • Ala Ebaid
        • 接触：
    • New York
      • New York、New York、美国、10029
        • 尚未招聘
        • Icahn School of Medicine at Mount Sinai
        • 首席研究员：
          • John Mascarenhas
        • 接触：
      • New York、New York、美国、10021
        • 尚未招聘
        • Memorial Sloan Kettering Cancer Center
        • 首席研究员：
          • Brian Chernak
        • 接触：
    • North Carolina
      • Durham、North Carolina、美国、27705
        • 尚未招聘
        • Duke Blood Cancer Center
        • 首席研究员：
          • Lindsay Rein
        • 接触：
      • Winston-Salem、North Carolina、美国、27103
        • 尚未招聘
        • Novant Health
        • 首席研究员：
          • James Dugan
        • 接触：
    • Ohio
      • Cleveland、Ohio、美国、44195
        • 尚未招聘
        • Cleveland Clinic
        • 首席研究员：
          • Aaron Gerds
        • 接触：
    • Oregon
      • Portland、Oregon、美国、97239
        • 尚未招聘
        • Oregon Health and Science University
        • 接触：
        • 首席研究员：
          • Jessica Stempel
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19107
        • 尚未招聘
        • Thomas Jefferson University
        • 首席研究员：
          • Lindsay Wilde
        • 接触：
      • Pittsburgh、Pennsylvania、美国、15219
        • 尚未招聘
        • University of Pittsburgh Medical Center
        • 接触：
        • 首席研究员：
          • James Rossetti
      • Pittsburgh、Pennsylvania、美国、15224
        • 尚未招聘
        • Allegheny Health Network Cancer Institute - West Penn Hospital Location
        • 首席研究员：
          • Anna Koget
        • 接触：
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • 尚未招聘
        • Medical University of South Carolina
        • 首席研究员：
          • Praneeth Baratam
        • 接触：
    • Tennessee
      • Nashville、Tennessee、美国、37232-0021
        • 尚未招聘
        • Vanderbilt-Ingram Cancer Center (VICC)-Nashville
        • 首席研究员：
          • Ashwin Kishtagari
        • 接触：
    • Texas
      • Dallas、Texas、美国、75246
        • 尚未招聘
        • Baylor University Medical Center
        • 接触：
        • 首席研究员：
          • Micah Burch
      • Houston、Texas、美国、77030
        • 尚未招聘
        • MD Anderson Cancer Center
        • 首席研究员：
          • Prithviraj Bose
        • 接触：
      • Houston、Texas、美国、77090
        • 招聘中
        • LUMI Research
        • 首席研究员：
          • David Nguyen
        • 接触：
      • Houston、Texas、美国、77030
        • 尚未招聘
        • The University of Utah-Huntsman Cancer Institute
        • 首席研究员：
          • Srinivas Tantravahi
        • 接触：
    • Washington
      • Seattle、Washington、美国、98109
        • 尚未招聘
        • University of Washington
        • 首席研究员：
          • Anna Halpern
        • 接触：
  • 英国
      • London、英国、SE1 9RT
        • 尚未招聘
        • Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
        • 首席研究员：
          • Claire Harrison
        • 接触：
      • London、英国、NW1 2PG
        • 尚未招聘
        • UCL Cancer Institute - University College London Hospitals NHS Foundation Trust
        • 首席研究员：
          • Jonathan Lambert
        • 接触：
    • East Midlands
      • Lincoln、East Midlands、英国、LN2 5QY
        • 尚未招聘
        • United Lincolnshire Teaching Hospitals NHS Trust
        • 首席研究员：
          • Ciro Rinaldi
        • 接触：
    • Leicestershire
      • Leicester、Leicestershire、英国、LE1 5WW
        • 尚未招聘
        • University Hospital of Leicester NHS
        • 首席研究员：
          • Mamta Garg
        • 接触：
    • London, City of
      • London、London, City of、英国、W12 0HS
        • 尚未招聘
        • Imperial College Healthcare NHS Trust
        • 首席研究员：
          • Simone Claudiani
        • 接触：
    • Tyne and Wear
      • Sunderland、Tyne and Wear、英国、SR4 7TP
        • 尚未招聘
        • Sunderland and South Tyneside NHS Foundation Trust
        • 首席研究员：
          • Scott Marshall
        • 接触：
    • W Mids
      • Birmingham、W Mids、英国
        • 尚未招聘
        • Birmingham Heartlands Hospital
        • 接触：
        • 首席研究员：
          • Joanne Ewing
  • 西班牙
      • Barcelona、西班牙、08035
        • 尚未招聘
        • Hospital Universitari Vall d'Hebron
        • 首席研究员：
          • Maria Laura Fox
        • 接触：
      • Madrid、西班牙、28034
        • 尚未招聘
        • Hospital Ramon y Cajal
        • 接触：
        • 首席研究员：
          • Jose Valentin Garcia-Gutierrez
      • Salamanca、西班牙、37007
        • 尚未招聘
        • Universidad de Salamanca - Hospital Universitario de Salamanca
        • 首席研究员：
          • Jesús María Hernández Rivas
        • 接触：
          • Site Contact
          • 电话号码：626308549
          • 邮箱：jmhr@usal.es
      • Valencia、西班牙、46026
        • 尚未招聘
        • Hospital Universitari i Politecnic La Fe
        • 首席研究员：
          • Elvira Mora Castera
        • 接触：
    • Barcelona
      • Badalona、Barcelona、西班牙、8916
        • 尚未招聘
        • Institut Catala D'oncologia
        • 首席研究员：
          • Blanca Xicoy Cirici
        • 接触：
      • L'Hospitalet de Llobregat、Barcelona、西班牙、08908
        • 尚未招聘
        • Institut Catala d'Oncologia Hospital Duran y Renals
        • 接触：
        • 首席研究员：
          • Jasson Villarreal
    • LAS Palmas
      • Las Palmas de Gran Canaria、LAS Palmas、西班牙、35010
        • 尚未招聘
        • Hospital Universitario de Gran Canaria Doctor Negrin
        • 首席研究员：
          • Adrian Segura Diaz
        • 接触：
    • M
      • Málaga、M、西班牙、29003
        • 尚未招聘
        • Hospital Universitario Virgen de la Victoria
        • 首席研究员：
          • Regina Garcia-Delgado
        • 接触：
  • 阿根廷
      • Buenos Aires、阿根廷、CPC1118AAT
        • 尚未招聘
        • Hospital Aleman (HA) Deutsches Hospital
        • 接触：
        • 首席研究员：
          • Maria De Los Angeles Vicente Reparaz
      • Córdoba、阿根廷、5000
        • 尚未招聘
        • BRCR Global
        • 接触：
        • 首席研究员：
          • Karla Di Sisto
    • Buenos Aires
      • Pilar、Buenos Aires、阿根廷、B1629AHJ
        • 尚未招聘
        • Hospital Universitario Austral
        • 接触：
        • 首席研究员：
          • Silvio Carricondo
    • Ciudad Autonoma de BuenosAires
      • Buenos Aires、Ciudad Autonoma de BuenosAires、阿根廷、1405
        • 尚未招聘
        • Swiss Medical Center Barrio Parque
        • 首席研究员：
          • Claudio Marcelo Iastrebner
        • 接触：
    • Santa Fe Province
      • Rosario、Santa Fe Province、阿根廷、2000
        • 尚未招聘
        • Instituto Medico de la Fundacion Estudios Clinicos
        • 首席研究员：
          • Gustavo Jorge Braidot
        • 接触：
      • Rosario、Santa Fe Province、阿根廷、S2000GAP
        • 尚未招聘
        • Hospital Privado de Rosario
        • 首席研究员：
          • Jose Luis Fedele
        • 接触：
  • 韩国
      • Daegu、韩国、42472
        • 尚未招聘
        • Daegu Catholic University Medical Center
        • 首席研究员：
          • Sung Hwa Bae
        • 接触：
      • Seoul、韩国、3080
        • 尚未招聘
        • Seoul National University Hospital
        • 首席研究员：
          • Junshik Hong
        • 接触：
      • Seoul、韩国、137-701
        • 尚未招聘
        • The Catholic University of Korea
        • 首席研究员：
          • Sung-Eun Lee
        • 接触：
    • Gangnam-gu
      • Seoul、Gangnam-gu、韩国
        • 尚未招聘
        • Samsung Medical Center
        • 接触：
        • 首席研究员：
          • Chul Won Jung
    • Gyeonggi-do
      • Seongnam-si、Gyeonggi-do、韩国、13620
        • 尚未招聘
        • Seoul National University Bundang Hospital
        • 首席研究员：
          • Soo-Mee Bang
        • 接触：
    • Seongbuk-gu
      • Seoul、Seongbuk-gu、韩国
        • 尚未招聘
        • Korea University Anam Hospital
        • 首席研究员：
          • Yong Park
        • 接触：
    • Seoul Teugbyeolsi
      • Seoul、Seoul Teugbyeolsi、韩国、04401
        • 尚未招聘
        • Soon Chun Hyang University Hospital Seoul
        • 首席研究员：
          • Seug Yun Yoon
        • 接触：
  • 马来西亚
    • Kuala Lumpur
      • Kuala Lumpur、Kuala Lumpur、马来西亚、59100
        • 尚未招聘
        • University Malaya Medical Centre
        • 接触：
        • 首席研究员：
          • Edmund Fui Min Chin
    • Pulau Pinang
      • George Town、Pulau Pinang、马来西亚、10990
        • 尚未招聘
        • Hospital Pulau Pinang
        • 接触：
        • 首席研究员：
          • Hong Keng Liew
    • Sabah
      • Kota Kinabalu、Sabah、马来西亚、88586
        • 尚未招聘
        • Hospital Queen Elizabeth
        • 接触：
        • 首席研究员：
          • Khaiteri Raghunathan
    • Selangor
      • Ampang、Selangor、马来西亚、68000
        • 尚未招聘
        • Hospital Ampang
        • 首席研究员：
          • Veena Selvaratnam
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：Elritercept
Elritercept, SC, injection
其他名称：
  • TAK-226
安慰剂比较：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.
药品：Elritercept
Elritercept, SC, injection
其他名称：
  • TAK-226
药品：Placebo
Elritercept-matching placebo

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
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
大体时间：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)

次要结果测量

结果测量
措施说明
大体时间
Proportion of Participants Who Achieve ≥50 Percent (%) Reduction in RBC Transfusion Burden From Baseline Over Any Consecutive 12-Week Period
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Up to approximately 7 years
Up to approximately 7 years
Time to Progression in Participants Who Develop AP MF
大体时间：Up to approximately 7 years
Up to approximately 7 years
Proportion of Participants Who Develop Blast Phase (BP) MF
大体时间：Up to approximately 7 years
Up to approximately 7 years
Time to Progression in Participants Who Develop BP MF
大体时间：Up to approximately 7 years
Up to approximately 7 years
Plasma Concentration-Time Data for Participants Treated With Elritercept
大体时间：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
大体时间：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)
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Takeda

调查人员

  • 研究主任：Study Director、Takeda

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月2日

初级完成 (估计的)

2029年12月7日

研究完成 (估计的)

2034年3月30日

研究注册日期

首次提交

2026年5月29日

首先提交符合 QC 标准的

2026年5月29日

首次发布 (实际的)

2026年6月3日

研究记录更新

最后更新发布 (实际的)

2026年8月24日

上次提交的符合 QC 标准的更新

2026年8月20日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TAK-226-3002
  • 2026-525660-17-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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.

IPD 共享访问标准

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.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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