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

20. august 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

324

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, CPC1118AAT
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        • Hospital Aleman (HA) Deutsches Hospital
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          • Maria De Los Angeles Vicente Reparaz
      • Córdoba, Argentina, 5000
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        • BRCR Global
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          • Karla Di Sisto
    • Buenos Aires
      • Pilar, Buenos Aires, Argentina, B1629AHJ
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        • Hospital Universitario Austral
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        • Hovedetterforsker:
          • Silvio Carricondo
    • Ciudad Autonoma de BuenosAires
      • Buenos Aires, Ciudad Autonoma de BuenosAires, Argentina, 1405
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        • Swiss Medical Center Barrio Parque
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          • Claudio Marcelo Iastrebner
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    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
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        • Instituto Medico de la Fundacion Estudios Clinicos
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          • Gustavo Jorge Braidot
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      • Rosario, Santa Fe Province, Argentina, S2000GAP
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        • Hospital Privado de Rosario
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          • Jose Luis Fedele
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  • Australia
    • Adelaide, SA
      • Bedford Park, Adelaide, SA, Australia, 5042
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        • Flinders Medical Centre
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          • David Ross
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    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
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        • Mid North Coast Cancer Institute (MNCCI)
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          • Kyle Crassini
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      • Cudgen, New South Wales, Australia, 2487
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        • Tweed Valley Hospital
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      • Kogarah, New South Wales, Australia, 2217
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        • South Eastern Sydney Local Health District
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  • Belgia
      • Antwerp, Belgia, 2030
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        • Ziekenhuis aan de Stroom-Cadix
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          • Nikki Granacher
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      • Yvoir, Belgia, 5530
    • Hainaut
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    • Vlaams-Brabant
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        • UZ Leuven
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          • Timothy Devos
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      • Roeselare, West-Vlaanderen, Belgia, 8800
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        • AZ Delta
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      • Porto Alegre, Rio Grande do Sul, Brasil, 90610-000
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        • Hospital Sao Lucas da PUCRS
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          • Mariza Schaan
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      • Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
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        • Porto Alegre Clinical Hospital (HCPA)
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          • Laura Maria Fogliatto
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      • Porto Alegre, Rio Grande do Sul, Brasil, 90110-270
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        • Hospital Mae De Deus - Integrated Oncology Center
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          • Marcelo Capra
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    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brasil, 22061080
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        • Centro de Ensino, Pesquisa e Inovacao do Hospital Sao Lucas (CEPIN HSL RJ / Rede Americas)
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          • Cristiane Solza
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brasil, 88020-210
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        • Grupo Elora Pesquisa Clinica
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          • Jaisson Bortolini
      • Joinville, Santa Catarina, Brasil, 89201-260
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        • Centro de Hematologia e Oncologia (CHO)
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          • Marcelo Pitombeira de Lacerda
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    • São Paulo
      • Jaú, São Paulo, Brasil, 17210-080
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        • Hospital Amaral Carvalho (HAC)
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          • Ederson Mattos
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  • Bulgaria
      • Pleven, Bulgaria, 5800
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        • UMHAT 'Dr. Georgi Stranski', EAD
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          • Vanya Slavcheva-Popova
      • Plovdiv, Bulgaria, 4002
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        • Dr. Pencho Georgiev - Outpatient Center
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          • Pencho Georgiev
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      • Sofia, Bulgaria, 1431
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        • UMHAT Sv. Ivan Rilski
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          • Atanas Radinoff
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      • Sofia, Bulgaria, 1797
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        • Specialized Hospital for Active Treatment of Haematological Diseases - Sofia
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          • Martin Donchev
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  • Canada
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        • Juravinski Cancer Centre
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        • Princess Margaret Cancer Centre
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    • Quebec
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        • McGill University Health Center
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        • Jewish General Hospital
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          • Shireen Sirhan
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  • Chile
    • Biobio
      • Concepción, Biobio, Chile, 4030000
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        • Hospital Cliniico Regional de Concepcion Dr
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          • Monica Romero
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    • Coquimbo Region
      • La Serena, Coquimbo Region, Chile, 01697
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        • IC La Serena Research
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          • Cleiden Villegas
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    • La Florida
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    • Santiago Metropolitan
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        • Immunocel
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        • Centro de Oncologia de Precision
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  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 0000000
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        • Hospital Pablo Tobon Uribe
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    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080002
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        • Clinica General del Norte De Barranquilla
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        • Hovedetterforsker:
          • Arturo Guzman
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110121
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        • Los Cobos Medical Center
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        • Hovedetterforsker:
          • Jheremy Reyes
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 11011
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        • Funcacion santa Fe De Bogota
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        • Hovedetterforsker:
          • Claudia Agudelo
  • Forente stater
    • Arizona
      • Gilbert, Arizona, Forente stater, 85234
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        • Banner MD Anderson Cancer Center
        • Hovedetterforsker:
          • Mark Faber
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    • California
      • Glendale, California, Forente stater, 91204
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        • Los Angeles Cancer Network
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        • Hovedetterforsker:
          • Saro Kasparian
      • Whittier, California, Forente stater, 90603
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        • Cancer and Blood Specialty Clinic
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          • Merrill Shum
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    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20007
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        • MedStar Georgetown University Hospital
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        • Hovedetterforsker:
          • Julia Cunningham
    • Florida
      • Coral Springs, Florida, Forente stater, 33065
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        • Advanced Research, LLC
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          • Sumit Sawhney
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      • Miami, Florida, Forente stater, 33143
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        • Bioresearch Partners
        • Hovedetterforsker:
          • Luis Rangel
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      • Orlando, Florida, Forente stater, 32804-4648
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        • AdventHealth - Cancer Institute - Orlando
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          • Ahmed Zakari
      • Tamarac, Florida, Forente stater, 33321
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        • Florida Clinical Trials Group
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          • Chintan Gandhi
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      • Tampa, Florida, Forente stater, 33612
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        • Moffit Cancer Center
        • Hovedetterforsker:
          • Andrew Kuykendall
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    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
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        • Emory University
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        • Hovedetterforsker:
          • Anthony Hunter
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02111
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        • Tufts Medical Center
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        • Hovedetterforsker:
          • Parva Bhatt
    • Missouri
      • St Louis, Missouri, Forente stater, 63110
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        • Washington University School of Medicine
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          • Amy Zhou
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    • Montana
      • Billings, Montana, Forente stater, 59101
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        • St. Vincent Regional Hospital Cancer Centers
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          • Patrick Cobb
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    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87102
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        • University of New Mexico Comprehensive Cancer Center
        • Hovedetterforsker:
          • Ala Ebaid
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    • New York
      • New York, New York, Forente stater, 10029
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        • Icahn School of Medicine at Mount Sinai
        • Hovedetterforsker:
          • John Mascarenhas
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      • New York, New York, Forente stater, 10021
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        • Memorial Sloan Kettering Cancer Center
        • Hovedetterforsker:
          • Brian Chernak
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    • North Carolina
      • Durham, North Carolina, Forente stater, 27705
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        • Duke Blood Cancer Center
        • Hovedetterforsker:
          • Lindsay Rein
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      • Winston-Salem, North Carolina, Forente stater, 27103
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        • Novant Health
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    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
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        • Cleveland Clinic
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          • Aaron Gerds
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    • Oregon
      • Portland, Oregon, Forente stater, 97239
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        • Oregon Health and Science University
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    • Pennsylvania
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        • Thomas Jefferson University
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        • University of Pittsburgh Medical Center
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          • James Rossetti
      • Pittsburgh, Pennsylvania, Forente stater, 15224
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        • Allegheny Health Network Cancer Institute - West Penn Hospital Location
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          • Anna Koget
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    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
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        • Medical University of South Carolina
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          • Praneeth Baratam
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    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232-0021
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        • Vanderbilt-Ingram Cancer Center (VICC)-Nashville
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          • Ashwin Kishtagari
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    • Texas
      • Dallas, Texas, Forente stater, 75246
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        • Baylor University Medical Center
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      • Houston, Texas, Forente stater, 77030
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        • MD Anderson Cancer Center
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          • Prithviraj Bose
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      • Houston, Texas, Forente stater, 77090
        • Rekruttering
        • LUMI Research
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          • David Nguyen
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      • Houston, Texas, Forente stater, 77030
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        • The University of Utah-Huntsman Cancer Institute
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    • Washington
      • Seattle, Washington, Forente stater, 98109
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        • University of Washington
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          • Anna Halpern
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  • Frankrike
    • Alpes Maritimes
      • Nice, Alpes Maritimes, Frankrike, 6002
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        • Chu De Nice
        • Hovedetterforsker:
          • Michael Loschi
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    • Auvergne-Rhône-Alpes
      • Pierre-Bénite, Auvergne-Rhône-Alpes, Frankrike, 69495
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        • Centre Hospitalier LYON SUD
        • Hovedetterforsker:
          • Vincent Alcazer
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    • Bas Rhin
      • Strasbourg, Bas Rhin, Frankrike, 67200
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        • CHU de Strasbourg
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        • Hovedetterforsker:
          • Shanti Ame
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, Frankrike, 13009
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        • Institut Paoli Calmettes
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        • Hovedetterforsker:
          • Jerome Rey
    • Finistere
      • Brest, Finistere, Frankrike, 29609
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        • Centre Hospitalier Regional Universitaire Brest Hopital Morvan
        • Hovedetterforsker:
          • Jean-Christophe Ianotto
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    • Gironde
      • Pessac, Gironde, Frankrike, 33600
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        • CHU de Bordeaux
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          • Clemence Mediavilla
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      • Lille, Nord, Frankrike, 59037
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        • Centre Hospitalier Regional Universitaire de Lille
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          • Mathieu Wemeau
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          • Lina Benajiba
    • Vienne
      • Poitiers, Vienne, Frankrike, 86021
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    • Ahaia
      • Pátrai, Ahaia, Hellas, 264 43
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        • Olympion General Clinic & Rehabilitation Center
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          • Argiris Symeonidis
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    • Attica
      • Athens, Attica, Hellas, 11528
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        • Alexandra General Hospital of Athens
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          • Meletios-Athanasios Dimopoulos
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      • Athens, Attica, Hellas, 11526
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        • Laiko General Hospital of Athens
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          • Theodoros Vassilakopoulos
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      • Athens, Attica, Hellas, 11527
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        • General Hospital
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      • Thessaloniki, Macedonia, Hellas, 54642
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        • Ippokrateion Hospital of Thessaloniki
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          • Eleni Gavriilaki
  • India
      • Delhi, India, 201012
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        • Max Super Specialty Hospital
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          • Rayaz Ahmed
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      • Gurgaon, Haryana, India, 122001
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        • Medanta- The Medicity- Gurugram
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          • Nitin Sood
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      • Kochi, Kerala, India, 682041
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          • Neeraj Sidharthan
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          • Sungeeth Thambi
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      • Pune, Maharashtra, India, 411004
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        • Sahyadri Super Speciality Hospital Deccan
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          • Shashikant Janardhan Apte
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      • Rohini, NEW Delhi, India, 110085
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          • Dinesh Bhurani
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      • New Delhi, National Capital Territory of Delhi, India, 110029
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          • Ranjit Sahoo
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          • Padmaja Lokireddy
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        • Tata Medical Center, Kolkata
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          • Arijit Nag
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      • Cork, Irland, T12 DC4A
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      • Dublin, Irland, D08 NHY1
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          • Catherine Flynn
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          • Su Maung
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          • Elena Mishchenko
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      • Haifa, North, Israel, 3109601
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        • Rambam Health Care Campus
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          • Inna Tzoran
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      • Tel Aviv, TLV, Israel, 64239
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        • The Tel Aviv Sourasky Medical Center
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          • Ilya Kirgner
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      • Ancona, Italia, 60121
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        • Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica
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        • Hovedetterforsker:
          • Erika Morsia
      • Catania, Italia, 95124
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        • Policlinico Universitario di Catania
        • Hovedetterforsker:
          • Giuseppe Palumbo
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      • Florence, Italia, 50134
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        • Azienda Ospedaliera Universitaria Careggi
        • Hovedetterforsker:
          • Alessandro Maria Vannucchi
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      • Torino, Italia, 10126
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        • AOU Citta della Salute e della Scienza di Torino
        • Ta kontakt med:
        • Hovedetterforsker:
          • Benevolo Giulia
      • Udine, Italia, 33100
        • Har ikke rekruttert ennå
        • Azienda Sanitaria Universitaria Friuli Centrale
        • Hovedetterforsker:
          • Mario Tiribelli
        • Ta kontakt med:
    • BO
      • Bologna, BO, Italia, 40138
        • Har ikke rekruttert ennå
        • IRCCS - AOU di Bologna - Sant Orsola Malpighi
        • Hovedetterforsker:
          • FRANCESCA PALANDRI
        • Ta kontakt med:
    • Ferrara
      • Cona, Ferrara, Italia, 44124
        • Har ikke rekruttert ennå
        • Universitaria di Ferrara Azienda Ospedaliero
        • Ta kontakt med:
        • Hovedetterforsker:
          • Giuseppe Auteri
    • Forli-Cesena
      • Meldola, Forli-Cesena, Italia, 47014
        • Har ikke rekruttert ennå
        • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l
        • Hovedetterforsker:
          • Alessandro Lucchesi
        • Ta kontakt med:
    • Lazio
      • Rome, Lazio, Italia, 00161
        • Har ikke rekruttert ennå
        • Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
        • Hovedetterforsker:
          • Massimo Breccia
        • Ta kontakt med:
      • Rome, Lazio, Italia, 144
        • Har ikke rekruttert ennå
        • Ospedale S Eugenio
        • Hovedetterforsker:
          • Elisabetta Abruzzese
        • Ta kontakt med:
    • MI
      • Milan, MI, Italia, 20122
        • Har ikke rekruttert ennå
        • Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano
        • Hovedetterforsker:
          • Francesco Passamonti
        • Ta kontakt med:
    • RM
      • Rome, RM, Italia, 00168
        • Har ikke rekruttert ennå
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Ta kontakt med:
        • Hovedetterforsker:
          • Elena Rossi
  • Japan
    • Chiba
      • Chiba, Chiba, Japan, 260-8717
        • Har ikke rekruttert ennå
        • Chiba Cancer Center
        • Hovedetterforsker:
          • Masahiro Takeuchi
        • Ta kontakt med:
    • Ehime
      • Toon-shi, Ehime, Japan, 791-0295
        • Har ikke rekruttert ennå
        • Ehime University Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Katsuto Takenaka
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Har ikke rekruttert ennå
        • Kobe City Medical Center General Hospital
        • Ta kontakt med:
          • Site Contact
          • Telefonnummer: 78-302-4321
        • Hovedetterforsker:
          • Yuya Nagai
    • Ibaraki
      • Hitachi, Ibaraki, Japan, 317-0077
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Har ikke rekruttert ennå
        • Mie University Hospital
        • Ta kontakt med:
          • Site Contact
          • Telefonnummer: 81(0)59-232-1111
        • Hovedetterforsker:
          • Yuka Sugimoto
    • Miyazaki
      • Miyazaki, Miyazaki, Japan, 889-1692
        • Har ikke rekruttert ennå
        • University of Miyazaki Hospital
        • Ta kontakt med:
          • Site Contact
          • Telefonnummer: 81-985-85-1510
        • Hovedetterforsker:
          • Kazuya Shimoda
    • Tokyo
      • Bunkyo-Ku, Tokyo, Japan, 113-8677
        • Har ikke rekruttert ennå
        • Tokyo Metropolitan Komagome Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Noriko Doki
    • Yamanashi
      • Chuo-shi, Yamanashi, Japan, 409-3898
        • Har ikke rekruttert ennå
        • University of Yamanashi Hospital
        • Hovedetterforsker:
          • Keita Kirito
        • Ta kontakt med:
  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
        • Har ikke rekruttert ennå
        • University Malaya Medical Centre
        • Ta kontakt med:
        • Hovedetterforsker:
          • Edmund Fui Min Chin
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10990
        • Har ikke rekruttert ennå
        • Hospital Pulau Pinang
        • Ta kontakt med:
        • Hovedetterforsker:
          • Hong Keng Liew
    • Sabah
      • Kota Kinabalu, Sabah, Malaysia, 88586
        • Har ikke rekruttert ennå
        • Hospital Queen Elizabeth
        • Ta kontakt med:
        • Hovedetterforsker:
          • Khaiteri Raghunathan
    • Selangor
      • Ampang, Selangor, Malaysia, 68000
        • Har ikke rekruttert ennå
        • Hospital Ampang
        • Hovedetterforsker:
          • Veena Selvaratnam
        • Ta kontakt med:
  • Mexico
    • Mexic
      • Monterrey, Mexic, Mexico, 64710
        • Har ikke rekruttert ennå
        • Universidad Autonoma de Nuevo Leon
        • Hovedetterforsker:
          • David Gomez Almaguer
        • Ta kontakt med:
    • Mexico de Mexico
      • Huixquilucan, Mexico de Mexico, Mexico, 52787
        • Har ikke rekruttert ennå
        • Hematologica Alta Especialidad S.C.
        • Ta kontakt med:
        • Hovedetterforsker:
          • Roberto Ovilla Martinez
    • Oaxaca
      • Oaxaca City, Oaxaca, Mexico, 68000
        • Har ikke rekruttert ennå
        • OSMO - Oaxaca Site Management Organization S.C
        • Ta kontakt med:
        • Hovedetterforsker:
          • Eva Ramirez Romero
  • Polen
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polen, 60-192
        • Har ikke rekruttert ennå
        • Pratia Poznań
        • Hovedetterforsker:
          • Anna Hoppe
        • Ta kontakt med:
    • Kuyavian-Pomeranian Voivodeship
      • Torun, Kuyavian-Pomeranian Voivodeship, Polen, 87-100
        • Har ikke rekruttert ennå
        • Wojewodzki Szpital Zespolony Im L Rydygiera
        • Hovedetterforsker:
          • Dominik Chraniuk
        • Ta kontakt med:
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 02-172
        • Har ikke rekruttert ennå
        • MTZ Clinical Research Powered by PRATIA
        • Hovedetterforsker:
          • Krzysztof Madry
        • Ta kontakt med:
    • Silesian Voivodeship
      • Chorzów, Silesian Voivodeship, Polen, 41-500
        • Har ikke rekruttert ennå
        • Zespol Szpitali Miejskich w Chorzowie
        • Ta kontakt med:
        • Hovedetterforsker:
          • Piotr Malecki
      • Katowice, Silesian Voivodeship, Polen, 40-519
        • Har ikke rekruttert ennå
        • Pratia Oncology Katowice
        • Hovedetterforsker:
          • Sebastian Grosicki
        • Ta kontakt med:
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Polen, 93-513
        • Har ikke rekruttert ennå
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Hematologii
        • Ta kontakt med:
        • Hovedetterforsker:
          • Joanna Gora-Tybor
  • Romania
      • Bucharest, Romania, 20125
        • Har ikke rekruttert ennå
        • Colentina Clinical Hospital
        • Hovedetterforsker:
          • Mihaela Andreescu
        • Ta kontakt med:
      • Timișoara, Romania, 300700
        • Har ikke rekruttert ennå
        • Spitalul Clinic Municipal de Urgenta Timisoara
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ioana Ionita
    • CJ
      • Cluj-Napoca, CJ, Romania, 400124
        • Har ikke rekruttert ennå
        • Institutul Oncologic Prof. Dr. Ion Chiricuta
        • Hovedetterforsker:
          • Ciprian Tomuleasa
        • Ta kontakt med:
    • Dolj
      • Craiova, Dolj, Romania, 200143
        • Har ikke rekruttert ennå
        • Spitalul Municipal Filantropia Craiova
        • Hovedetterforsker:
          • Luminita Ocroteala
        • Ta kontakt med:
  • Saudi-Arabia
      • Riyadh, Saudi-Arabia, 12372
        • Har ikke rekruttert ennå
        • King Khalid University Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Musa Alzahrani
      • Riyadh, Saudi-Arabia, 11211
        • Har ikke rekruttert ennå
        • King Faisal Specialist Hospital & Research Centre Riyadh
        • Ta kontakt med:
        • Hovedetterforsker:
          • Marwan Shaheen
  • Spania
      • Barcelona, Spania, 08035
        • Har ikke rekruttert ennå
        • Hospital Universitari Vall d'Hebron
        • Hovedetterforsker:
          • Maria Laura Fox
        • Ta kontakt med:
      • Madrid, Spania, 28034
        • Har ikke rekruttert ennå
        • Hospital Ramon y Cajal
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jose Valentin Garcia-Gutierrez
      • Salamanca, Spania, 37007
        • Har ikke rekruttert ennå
        • Universidad de Salamanca - Hospital Universitario de Salamanca
        • Hovedetterforsker:
          • Jesús María Hernández Rivas
        • Ta kontakt med:
          • Site Contact
          • Telefonnummer: 626308549
          • E-post: jmhr@usal.es
      • Valencia, Spania, 46026
        • Har ikke rekruttert ennå
        • Hospital Universitari i Politecnic La Fe
        • Hovedetterforsker:
          • Elvira Mora Castera
        • Ta kontakt med:
    • Barcelona
      • Badalona, Barcelona, Spania, 8916
        • Har ikke rekruttert ennå
        • Institut Catala D'oncologia
        • Hovedetterforsker:
          • Blanca Xicoy Cirici
        • Ta kontakt med:
      • L'Hospitalet de Llobregat, Barcelona, Spania, 08908
        • Har ikke rekruttert ennå
        • Institut Catala d'Oncologia Hospital Duran y Renals
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jasson Villarreal
    • LAS Palmas
      • Las Palmas de Gran Canaria, LAS Palmas, Spania, 35010
        • Har ikke rekruttert ennå
        • Hospital Universitario de Gran Canaria Doctor Negrin
        • Hovedetterforsker:
          • Adrian Segura Diaz
        • Ta kontakt med:
    • M
      • Málaga, M, Spania, 29003
        • Har ikke rekruttert ennå
        • Hospital Universitario Virgen de la Victoria
        • Hovedetterforsker:
          • Regina Garcia-Delgado
        • Ta kontakt med:
  • Storbritannia
      • London, Storbritannia, SE1 9RT
        • Har ikke rekruttert ennå
        • Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
        • Hovedetterforsker:
          • Claire Harrison
        • Ta kontakt med:
      • London, Storbritannia, NW1 2PG
        • Har ikke rekruttert ennå
        • UCL Cancer Institute - University College London Hospitals NHS Foundation Trust
        • Hovedetterforsker:
          • Jonathan Lambert
        • Ta kontakt med:
    • East Midlands
      • Lincoln, East Midlands, Storbritannia, LN2 5QY
        • Har ikke rekruttert ennå
        • United Lincolnshire Teaching Hospitals NHS Trust
        • Hovedetterforsker:
          • Ciro Rinaldi
        • Ta kontakt med:
    • Leicestershire
      • Leicester, Leicestershire, Storbritannia, LE1 5WW
        • Har ikke rekruttert ennå
        • University Hospital of Leicester NHS
        • Hovedetterforsker:
          • Mamta Garg
        • Ta kontakt med:
    • London, City of
      • London, London, City of, Storbritannia, W12 0HS
        • Har ikke rekruttert ennå
        • Imperial College Healthcare NHS Trust
        • Hovedetterforsker:
          • Simone Claudiani
        • Ta kontakt med:
    • Tyne and Wear
      • Sunderland, Tyne and Wear, Storbritannia, SR4 7TP
        • Har ikke rekruttert ennå
        • Sunderland and South Tyneside NHS Foundation Trust
        • Hovedetterforsker:
          • Scott Marshall
        • Ta kontakt med:
    • W Mids
      • Birmingham, W Mids, Storbritannia
        • Har ikke rekruttert ennå
        • Birmingham Heartlands Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Joanne Ewing
  • Sverige
      • Stockholm, Sverige, 14186
        • Har ikke rekruttert ennå
        • Karolinska University Hospital
        • Hovedetterforsker:
          • Anne-Marie Landtblom
        • Ta kontakt med:
      • Örebro, Sverige, 70185
        • Har ikke rekruttert ennå
        • Örebro University Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Erik Ahlstrand
  • Sør -Korea
      • Daegu, Sør -Korea, 42472
        • Har ikke rekruttert ennå
        • Daegu Catholic University Medical Center
        • Hovedetterforsker:
          • Sung Hwa Bae
        • Ta kontakt med:
      • Seoul, Sør -Korea, 3080
        • Har ikke rekruttert ennå
        • Seoul National University Hospital
        • Hovedetterforsker:
          • Junshik Hong
        • Ta kontakt med:
      • Seoul, Sør -Korea, 137-701
        • Har ikke rekruttert ennå
        • The Catholic University of Korea
        • Hovedetterforsker:
          • Sung-Eun Lee
        • Ta kontakt med:
    • Gangnam-gu
      • Seoul, Gangnam-gu, Sør -Korea
        • Har ikke rekruttert ennå
        • Samsung Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Chul Won Jung
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Sør -Korea, 13620
        • Har ikke rekruttert ennå
        • Seoul National University Bundang Hospital
        • Hovedetterforsker:
          • Soo-Mee Bang
        • Ta kontakt med:
    • Seongbuk-gu
      • Seoul, Seongbuk-gu, Sør -Korea
        • Har ikke rekruttert ennå
        • Korea University Anam Hospital
        • Hovedetterforsker:
          • Yong Park
        • Ta kontakt med:
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Sør -Korea, 04401
        • Har ikke rekruttert ennå
        • Soon Chun Hyang University Hospital Seoul
        • Hovedetterforsker:
          • Seug Yun Yoon
        • Ta kontakt med:
  • Taiwan
      • Kaohsiung City, Taiwan
        • Har ikke rekruttert ennå
        • Kaohsiung Medical University Hospital
        • Hovedetterforsker:
          • Yi-Chang Liu
        • Ta kontakt med:
      • Taichung, Taiwan, 40705
        • Har ikke rekruttert ennå
        • Taichung Veterans General Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tsung Chih Chen
      • Tainan, Taiwan, 70403
        • Har ikke rekruttert ennå
        • National Cheng Kung University Hospital
        • Hovedetterforsker:
          • Tsai-Yun Chen
        • Ta kontakt med:
    • Beitou
      • Taipei, Beitou, Taiwan, 11217
        • Har ikke rekruttert ennå
        • Taipei Veterans General Hospital
        • Hovedetterforsker:
          • Chih-Cheng Chen
        • Ta kontakt med:
    • Taiwan (r.o.c.)
      • Taipei, Taiwan (r.o.c.), Taiwan, 100
        • Har ikke rekruttert ennå
        • National Taiwan University Hospital
        • Hovedetterforsker:
          • Hsin-An Hou
        • Ta kontakt med:
  • Tsjekkia
      • Prague, Tsjekkia, 134 00
        • Har ikke rekruttert ennå
        • Fakultni nemocnice Kralovske Vinohrady
        • Hovedetterforsker:
          • Olga Cerna
        • Ta kontakt med:
    • CZ
      • Hradec Králové, CZ, Tsjekkia, 50005
        • Har ikke rekruttert ennå
        • Fakultni nemocnice Hradec Kralove
        • Hovedetterforsker:
          • Petra Belohlavkova
        • Ta kontakt med:
      • Prague, CZ, Tsjekkia, 12808
        • Har ikke rekruttert ennå
        • Vseobecna fakultni nemocnice Praha
        • Hovedetterforsker:
          • Anna Jonasova
        • Ta kontakt med:
    • Czech Republic
      • Brno, Czech Republic, Tsjekkia, 625 00
        • Har ikke rekruttert ennå
        • Masaryk University Hospital Brno, Department of Internal Medicine, Hematology and Oncology
        • Ta kontakt med:
        • Hovedetterforsker:
          • Barbora Weinbergerova
  • Tyrkia (Türkiye)
      • Istanbul, Tyrkia (Türkiye), 34381
        • Har ikke rekruttert ennå
        • Istanbul Florence Nightingale Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Omur Sevindik
      • Istanbul, Tyrkia (Türkiye), 34303
        • Har ikke rekruttert ennå
        • Istanbul University-CerrahpaAYa, CerrahpaAYa Faculty of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ahmet Emre Eskazan
    • Ankara
      • Çankaya, Ankara, Tyrkia (Türkiye), 06800
        • Har ikke rekruttert ennå
        • Ankara Bilkent City Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Marve Pamukcuoglu
    • Mezitli
      • Mersin, Mezitli, Tyrkia (Türkiye), 33000
        • Har ikke rekruttert ennå
        • VM Medical Park Mersin Hospital
        • Hovedetterforsker:
          • Anil Tombak
        • Ta kontakt med:
  • Tyskland
      • Berlin, Tyskland, 10715
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Tyskland, 79106
        • Har ikke rekruttert ennå
        • Universitaetsklinikum Freiburg
        • Ta kontakt med:
        • Hovedetterforsker:
          • Heiko Becker
      • Heidelberg, Baden-Wurttemberg, Tyskland, 69120
        • Har ikke rekruttert ennå
        • Universitaetsklinikum Heidelberg (UKHD)
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tim Sauer
      • Mutlangen, Baden-Wurttemberg, Tyskland, 73557
        • Har ikke rekruttert ennå
        • Kliniken Ostalb
        • Hovedetterforsker:
          • Holger Hebart
        • Ta kontakt med:
    • North Rhine-Westphalia
      • Minden, North Rhine-Westphalia, Tyskland, 32429
        • Har ikke rekruttert ennå
        • Muehlenkreiskliniken AoeR-Johannes Wesling Klinikum Minden - Universitaetsklinik fuer Neurologie und Neurogeriatrie
        • Hovedetterforsker:
          • Martin Griesshammer
        • Ta kontakt med:
    • Rhineland-Palatinate
      • Koblenz, Rhineland-Palatinate, Tyskland, 56068
        • Har ikke rekruttert ennå
        • Institut fur Versorgungsforschung in der Onkologie GbR
        • Ta kontakt med:
        • Hovedetterforsker:
          • Cristoph Lutz
    • Saxony
      • Chemnitz, Saxony, Tyskland, 9116
        • Har ikke rekruttert ennå
        • Klinikum Chemnitz GmbH
        • Hovedetterforsker:
          • Mathias Hanel
        • Ta kontakt med:
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Tyskland, 06120
        • Har ikke rekruttert ennå
        • University Hospital Halle (Saale)
        • Hovedetterforsker:
          • Haifa Kathrin Al-Ali
        • Ta kontakt med:
    • Thuringia
      • Jena, Thuringia, Tyskland, 7743
        • Har ikke rekruttert ennå
        • Universitaetsklinikum Jena
        • Hovedetterforsker:
          • Carl Crodel
        • Ta kontakt med:
  • Ungarn
    • HB
      • Debrecen, HB, Ungarn, 4032
        • Har ikke rekruttert ennå
        • Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika
        • Hovedetterforsker:
          • Arpad Illes
        • Ta kontakt med:
    • Komarom-Esztergom VArmegye
      • Tatabánya, Komarom-Esztergom VArmegye, Ungarn, 2800
        • Har ikke rekruttert ennå
        • Komárom-Esztergom Vármegyei Szent Borbála Kórház
        • Hovedetterforsker:
          • Zsofia Simon
        • Ta kontakt med:
  • Østerrike
      • Linz, Østerrike, 4020
        • Har ikke rekruttert ennå
        • Ordensklinikum Linz Elisabethinen
        • Hovedetterforsker:
          • Veronika Buxhofer-Ausch
        • Ta kontakt med:
    • A
      • Vienna, A, Østerrike, 1090
        • Har ikke rekruttert ennå
        • Medizinische Universitat Wien (Medical University of Vienna - Austria)
        • Ta kontakt med:
        • Hovedetterforsker:
          • Maria-Theresa Krauth
    • Tyrol
      • Innsbruck, Tyrol, Østerrike, 6020
        • Har ikke rekruttert ennå
        • Medizinische Universität Innsbruck
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dominik Wolf
    • Upper Austria
      • Wels, Upper Austria, Østerrike, 4600
        • Har ikke rekruttert ennå
        • Klinikum Wels-Grieskirchen
        • Hovedetterforsker:
          • Sonja Heibl
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Elritercept
Elritercept, SC, injection
Andre navn:
  • TAK-226
Placebo komparator: 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.
Legemiddel: Elritercept
Elritercept, SC, injection
Andre navn:
  • TAK-226
Legemiddel: Placebo
Elritercept-matching placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Participants Who Achieve ≥50 Percent (%) Reduction in RBC Transfusion Burden From Baseline Over Any Consecutive 12-Week Period
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to approximately 7 years
Up to approximately 7 years
Time to Progression in Participants Who Develop AP MF
Tidsramme: Up to approximately 7 years
Up to approximately 7 years
Proportion of Participants Who Develop Blast Phase (BP) MF
Tidsramme: Up to approximately 7 years
Up to approximately 7 years
Time to Progression in Participants Who Develop BP MF
Tidsramme: Up to approximately 7 years
Up to approximately 7 years
Plasma Concentration-Time Data for Participants Treated With Elritercept
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Takeda

Etterforskere

  • Studieleder: Study Director, Takeda

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

2. september 2026

Primær fullføring (Antatt)

7. desember 2029

Studiet fullført (Antatt)

30. mars 2034

Datoer for studieregistrering

Først innsendt

29. mai 2026

Først innsendt som oppfylte QC-kriteriene

29. mai 2026

Først lagt ut (Faktiske)

3. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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