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빈혈을 동반한 골수이형성증후군(MDS) 위험도가 매우 낮거나, 낮거나 중간 정도인 성인 참가자에 대한 Elritercept의 효능 및 안전성(RENEW)

2026년 11월 5일 업데이트: Takeda

위험도가 매우 낮거나, 낮거나, 중간 정도인 성인 참가자의 수혈 의존성 빈혈 치료를 위한 Elritercept(KER-050)의 효능과 안전성을 평가하기 위한 3상, 무작위, 이중 맹검, 위약 대조 연구 골수이형성증후군(MDS)(갱신)

The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This is a Phase 3, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of elritercept (TAK-226, KER-050) versus placebo. Elritercept (TAK-226, KER-050) is an investigational medicinal product being developed for the treatment of anemia in adult participants with a diagnosis of lower-risk myelodysplastic neoplasms/syndromes. After all required Screening Period assessments are completed, and eligibility is confirmed, participants will be randomized and enter the Primary Phase of the Double-Blind Treatment Period. Participants will be randomly assigned in a 2:1 ratio to receive either elritercept (TAK-226, KER-050) or placebo subcutaneously (SC) every 4 weeks (Q4W). Participants will be stratified according to their ring sideroblasts (RS) status (RS-positive versus non-RS) and baseline transfusion burden (low-transfusion burden [LTB] versus high transfusion burden [HTB]). The Primary Phase of the Double-blind Treatment Period will last 24 weeks. The Secondary Phase of the Double-Blind Treatment Period will last an additional 24 weeks. During the Secondary Phase of the Double-Blind Treatment Period, all participants will continue to receive the same double-blind treatment they received during the Primary Phase. Study visits will occur approximately every 2 weeks from Cycle 1 through Cycle 6 and every 4 weeks from Cycle 7 through the remainder of the Double-Blind Treatment Period. During the Extension Phase of the Double-Blind Treatment Period, all eligible participants will continue to receive the same double-blind treatment they received during the Primary and Secondary Phases. Participants will continue in the Extension Phase until they individually discontinue or until the study is unblinded. For participants to remain on double-blind treatment, they must meet the criteria outlined in the MDS disease assessment criteria every 24 weeks. Based on the outcome of the Week 24 MDS disease assessment, participants will either continue in the Extension Phase of the Double-blind Treatment Period or will be discontinued from treatment and proceed to End of Treatment and then into the Safety Follow-up Period. The Safety Follow-Up Period will extend from the last dose of study treatment through 8 weeks after the last dose of study treatment. Study visits should occur every 4 weeks within the Safety Follow-Up Period. Long-term follow-up will take place quarterly after a participant has completed the Safety Follow-Up Period. Long-term follow-up will continue for 5 years from the first dose of study treatment, or until a participant is deceased, is lost to follow-up, withdraws consent, or the study closes, whichever is earliest.

연구 유형

중재적

등록 (추정된)

225

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 남아프리카
      • Cape Town, 남아프리카, 7580
        • 모병
        • Haemalife
        • 연락하다:
        • 수석 연구원:
          • Michael Cass
      • Durban, 남아프리카, 4091
        • 모병
        • Capital Haematology Hospital
        • 수석 연구원:
          • Jaimendra Singh
        • 연락하다:
      • Johannesburg, 남아프리카, 2193
        • 모병
        • Charlotte Maxeke Johannesburg Academic Hospital, Hemophilia Comprehensive Care Center
        • 연락하다:
        • 수석 연구원:
          • Johnny Mahlangu
      • Pretoria, 남아프리카, 0181
        • 모병
        • Alberts Cellular Therapy
        • 수석 연구원:
          • Andrew McDonald
        • 연락하다:
  • 대만
      • Taichung, 대만, 407219
        • 모병
        • Taichung Veterans General Hospital
        • 수석 연구원:
          • Cheng-Hsien Lin
        • 연락하다:
      • Tainan, 대만, 704302
        • 모병
        • National Cheng Kung University Hospital
        • 수석 연구원:
          • Tsai-Yun Chen
        • 연락하다:
      • Taipei, 대만, 100225
        • 모병
        • National Taiwan University Hospital
        • 수석 연구원:
          • Wen-Chien Chou
        • 연락하다:
      • Taoyuan City, 대만, 333
        • 모병
        • Linkou Chang Gung Memorial Hospital
        • 수석 연구원:
          • Ming-Chung Kuo
        • 연락하다:
    • Changhua County
      • Changhua, Changhua County, 대만, 500209
        • 모병
        • Changhua Christian Hospital
        • 연락하다:
        • 수석 연구원:
          • Ruo-Han Tseng
      • Changhua, Changhua County, 대만, 50544
        • 모병
        • Chang Bing Show Chwan Memorial Hospital
        • 수석 연구원:
          • Cheng-Shyong Chang
        • 연락하다:
  • 대한민국
      • Daegu, 대한민국, 41944
        • 모병
        • Kyungpook National University Hospital
        • 연락하다:
        • 수석 연구원:
          • Joon ho Moon
      • Seoul, 대한민국, 05505
        • 모병
        • Asan Medical Center
        • 수석 연구원:
          • Je-Hwan Lee
        • 연락하다:
      • Seoul, 대한민국, 03080
        • 모병
        • Seoul National University Hospital
        • 수석 연구원:
          • Junshik Hong
        • 연락하다:
      • Seoul, 대한민국, 06351
        • 모병
        • Samsung Medical Center
        • 수석 연구원:
          • Jun Ho Jang
        • 연락하다:
      • Seoul, 대한민국, 04401
        • 모병
        • Soon Chun Hyang University Hospital Seoul
        • 수석 연구원:
          • Seug Yun Yoon
        • 연락하다:
      • Seoul, 대한민국, 06591
        • 모병
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • 수석 연구원:
          • Yoo Jin Kim
        • 연락하다:
  • 독일
      • Berlin, 독일, 10715
      • Berlin, 독일, 12203
        • 모병
        • Charite Universitatsmedizin Berlin
        • 수석 연구원:
          • Kathrin Rieger
        • 연락하다:
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, 독일, 53127
        • 아직 모집하지 않음
        • University Hospital Bronn
        • 수석 연구원:
          • Karin Mayer
        • 연락하다:
      • Düsseldorf, North Rhine-Westphalia, 독일, 40479
        • 모병
        • Marien Hospital Duesseldorf GmbH, Clinic for Oncology, Hematology and Palliative Medicine
        • 연락하다:
        • 수석 연구원:
          • Aristoteles Giagounidis
    • Saxony
      • Leipzig, Saxony, 독일, 04103
        • 모병
        • University Hospital Leipzig, Clinic and Policlinic for Internal Medicine I Haematology and Stem Cell Therapy, Medical Oncology, Haemostaseology
        • 수석 연구원:
          • Dominic Brauer
        • 연락하다:
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, 독일, 06120
        • 모병
        • University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
        • 연락하다:
        • 수석 연구원:
          • Haifa Al-Ali
      • Magdeburg, Saxony-Anhalt, 독일, 39120
        • 아직 모집하지 않음
        • University Clinic of Hematology, Oncology and Cell Therapy
        • 수석 연구원:
          • Berisha Mirjeta
        • 연락하다:
  • 리투아니아
      • Kaunas, 리투아니아, LT-50161
        • 모병
        • Hospital of Lithuanian University of Health Sciences Kauno Klinikos
        • 연락하다:
        • 수석 연구원:
          • Milda Rudzianskiene
      • Vilnius, 리투아니아, LT-08406
        • 모병
        • Vilnius University Hospital Santaros Klinikos
        • 수석 연구원:
          • Andrius Degulys
        • 연락하다:
  • 미국
    • California
      • Duarte, California, 미국, 91010
        • 모병
        • City of Hope
        • 수석 연구원:
          • Andrew Artz
        • 연락하다:
          • Site Contact
          • 전화번호: 626-218-2404
          • 이메일: aartz@coh.org
      • Glendale, California, 미국, 91206
        • 모병
        • Los Angeles Cancer Network
        • 수석 연구원:
          • Eric Lee
        • 연락하다:
      • La Jolla, California, 미국, 92037
        • 모병
        • UC San Diego Moores Cancer Center
        • 수석 연구원:
          • Amanda Kagan
        • 연락하다:
    • Connecticut
      • New Haven, Connecticut, 미국, 06511
        • 모병
        • Smilow Cancer Hospital at Yale-New Haven
        • 수석 연구원:
          • Amer Zeidan
        • 연락하다:
    • Florida
      • Miami, Florida, 미국, 33136
        • 모병
        • University of Miami Hospital and Clinics
        • 연락하다:
        • 수석 연구원:
          • Mikkael Sekeres
      • Tampa, Florida, 미국, 33612
        • 모병
        • Moffitt Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Rami Komrokji
    • Illinois
      • Peoria, Illinois, 미국, 61645
        • 모병
        • ILCC. Illinois Cancer Centers
        • 연락하다:
        • 수석 연구원:
          • Paul Fishkin
    • Kentucky
      • Louisville, Kentucky, 미국, 40207
        • 모병
        • Norton Cancer Institute
        • 수석 연구원:
          • Don Stevens
        • 연락하다:
    • Louisiana
      • Monroe, Louisiana, 미국, 71201
    • Maryland
      • Columbia, Maryland, 미국, 21044
        • 모병
        • Maryland Oncology Hematolofy
        • 수석 연구원:
          • Mohit Narang
        • 연락하다:
    • Missouri
      • Kansas City, Missouri, 미국, 64132
        • 모병
        • MidAmerica Cancer Care
        • 연락하다:
        • 수석 연구원:
          • Benjamin Fangman
    • Nevada
      • Henderson, Nevada, 미국, 89169
        • 모병
        • Comprehensive Cancer Centers of Nevada
        • 수석 연구원:
          • Edwin Kingsley
        • 연락하다:
    • New York
      • Westbury, New York, 미국, 11590
        • 모병
        • Clinical Research Alliance NY
        • 수석 연구원:
          • Jonathan Goldberg
        • 연락하다:
    • North Carolina
      • Winston-Salem, North Carolina, 미국, 27013
        • 모병
        • Novant Health-Cancer Institute
        • 수석 연구원:
          • James Dugan
        • 연락하다:
    • Ohio
      • Canton, Ohio, 미국, 44718
        • 모병
        • Gabrail Cancer Center Research
        • 수석 연구원:
          • Nashat Gabrail
        • 연락하다:
      • Cleveland, Ohio, 미국, 44195
        • 모병
        • Cleveland Clinic - Cleveland
        • 연락하다:
        • 수석 연구원:
          • Akriti Jain
    • Tennessee
      • Knoxville, Tennessee, 미국, 37909
        • 모병
        • Tennessee Cancer Specialists
        • 연락하다:
        • 수석 연구원:
          • Tracy Dobbs
      • Nashville, Tennessee, 미국, 37232
        • 모병
        • Vanderbilt University Medical Center
        • 수석 연구원:
          • Ashwin Kishtagari
        • 연락하다:
    • Texas
      • Denison, Texas, 미국, 75020
        • 모병
        • Texas Oncology Northeast Texas
        • 수석 연구원:
          • Amir Faridi
        • 연락하다:
      • Houston, Texas, 미국, 77090
      • Houston, Texas, 미국, 77030
        • 모병
        • U.T. MD Anderson Cancer Center, Division of Cancer Medicine
        • 수석 연구원:
          • Guillermo Garcia-Manero
        • 연락하다:
      • Red Oak, Texas, 미국, 75154
      • The Woodlands, Texas, 미국, 77380
        • 모병
        • Texas Oncology Gulf Coast
        • 수석 연구원:
          • Andrew Jackson
        • 연락하다:
      • Webster, Texas, 미국, 77598-4085
        • 모병
        • Tranquil Research
        • 수석 연구원:
          • John Knecht
        • 연락하다:
    • Washington
      • Issaquah, Washington, 미국, 98029
        • 아직 모집하지 않음
        • Epic Care Emeryville
        • 연락하다:
        • 수석 연구원:
          • Rajesh Behl
  • 불가리아
      • Plovdiv, 불가리아, 4002
        • 모병
        • Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD)
        • 연락하다:
        • 수석 연구원:
          • Pencho Georgiev
      • Sofia, 불가리아, 1431
        • 모병
        • University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology
        • 수석 연구원:
          • Atanas Radinoff
        • 연락하다:
      • Sofia, 불가리아, 1606
        • 모병
        • Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical Academy, Clinic of Hematology
        • 연락하다:
        • 수석 연구원:
          • Viktoria Barbukova
      • Sofia, 불가리아, 1797
        • 모병
        • Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology
        • 연락하다:
        • 수석 연구원:
          • Tanya Yankova
      • Varna, 불가리아, 9010
        • 아직 모집하지 않음
        • University Multiprofile Hospital for Active Treatment "Sveta Marina", Clinic of Clinical Hematology
        • 수석 연구원:
          • Ilina Micheva
        • 연락하다:
  • 브라질
      • Rio de Janeiro, 브라질, 22775-001
      • São Paulo, 브라질, 01323-900
        • 모병
        • Portuguese Charity of Sao Paulo, Clinical Hematology / Oncology Center
        • 연락하다:
        • 수석 연구원:
          • Phillip Scheinberg
      • São Paulo, 브라질, 01509-900
        • 모병
        • Hospital A.C.Camargo ("Antonio Prudente" Foundation)
        • 수석 연구원:
          • Marina Nascimento
        • 연락하다:
      • São Paulo, 브라질, 11075-900
        • 모병
        • Santa Casa of Mercy of Santos
        • 수석 연구원:
          • Elaine Mancilha
        • 연락하다:
    • Paraná
      • Curitiba, Paraná, 브라질, 81520-060
        • 모병
        • Hosptial Erasto Gaertner
        • 연락하다:
        • 수석 연구원:
          • Eduardo Munhoz
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, 브라질, 90610-000
        • 모병
        • Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
        • 수석 연구원:
          • Mariza Schaan
        • 연락하다:
      • Porto Alegre, Rio Grande do Sul, 브라질, 90035-903
        • 모병
        • Porto Alegre Clinical Hospital (HCPA)
        • 수석 연구원:
          • Laura Maria Fogliatto
        • 연락하다:
      • Porto Alegre, Rio Grande do Sul, 브라질, 90110-270
        • 모병
        • Hospital Mae de Deus, Clinical Research Unit - Cancer Institute
        • 수석 연구원:
          • Marcelo Capra
        • 연락하다:
    • Santa Catarina
      • Joinville, Santa Catarina, 브라질, 89201-260
        • 모병
        • Instituto Joinvilense de Hematologia e Oncologia
        • 연락하다:
        • 수석 연구원:
          • Lacerda Marcelo
    • São Paulo
      • Jaú, São Paulo, 브라질, 17210-080
      • Santo André, São Paulo, 브라질, 09060-650
      • São José do Rio Preto, São Paulo, 브라질, 15090-000
        • 모병
        • Sao Jose do Rio Preto Regional Faculty of Medicine Foundation
        • 수석 연구원:
          • Mariana Buka
        • 연락하다:
  • 스웨덴
      • Lund, 스웨덴, 221 85
        • 모병
        • Skane University Hospital - Lund, Department of Hematology and Vascular Disorders
        • 연락하다:
        • 수석 연구원:
          • Lars Nilsson
    • A-rebro County
      • Örebro, A-rebro County, 스웨덴, 70185
        • 아직 모집하지 않음
        • A-rebro University Hospital, Hematology Department
        • 연락하다:
        • 수석 연구원:
          • Bengt Rasmussen
    • Stockholm County
      • Huddinge, Stockholm County, 스웨덴, 141 57
        • 모병
        • Karolinska University Hospital
        • 수석 연구원:
          • Magnus Tobiasson
        • 연락하다:
    • VG
      • Gothenburg, VG, 스웨덴, 41345
        • 아직 모집하지 않음
        • Sahlgrenska University Hospital
        • 연락하다:
        • 수석 연구원:
          • Lena Von Bahr
  • 스위스
      • Bern, 스위스, 3010
        • 아직 모집하지 않음
        • Insel Gruppe AG, University Clinic for Hematology and Central Hematological Laboratory
        • 연락하다:
        • 수석 연구원:
          • Natalia Baran
      • Zurich, 스위스, 8091
        • 모병
        • Universitatsspital Zurich, Klinik fur Medizinische Onkologie und Hamatologie
        • 연락하다:
        • 수석 연구원:
          • Stefan Balabanov
    • Canton of Basel-City
      • Basel, Canton of Basel-City, 스위스, 4031
        • 아직 모집하지 않음
        • University Hosptial Basel
        • 연락하다:
        • 수석 연구원:
          • Gregor Stehle
  • 스페인
    • Castille and León
      • Salamanca, Castille and León, 스페인, 37007
        • 모병
        • University Clinical Hospital of Salamanca, Department of Hematology
        • 수석 연구원:
          • Maria Diez Campelo
        • 연락하다:
    • Catalonia
      • Barcelona, Catalonia, 스페인, 08035
        • 모병
        • University Hospital Vall d'Hebron, Department of Hematology
        • 수석 연구원:
          • David Valcarcel Ferreiras
        • 연락하다:
    • Girona
      • L'Hospitalet de Llobregat, Girona, 스페인, 08908
        • 모병
        • Catalan Institute of Oncology, Hospital Duran i Reynals, Department of Clinical Hematology
        • 수석 연구원:
          • Montserrat Arnan Sangerman
        • 연락하다:
    • Madrid
      • Madrid, Madrid, 스페인, 28034
        • 모병
        • University Hospital Ramon y Cajal
        • 수석 연구원:
          • Kyra Velazquez Kennedy
        • 연락하다:
      • Madrid, Madrid, 스페인, 28040
        • 모병
        • University Hospital Foundation Jimenez Diaz
        • 수석 연구원:
          • Teresa Arquero Portero
        • 연락하다:
    • Valencia
      • Valencia, Valencia, 스페인, 46026
        • 모병
        • University and Polytechnic Hospital La Fe
        • 수석 연구원:
          • Elvira Mora Castera
        • 연락하다:
  • 아일랜드
      • Cork, 아일랜드, T12 DC4A
        • 모병
        • Cork University Hospital
        • 수석 연구원:
          • Vitaliy Mykytiv
        • 연락하다:
      • Dublin, 아일랜드, D07 R2WY
        • 모병
        • Mater Misericordiae University Hospital
        • 수석 연구원:
          • Su Maung
        • 연락하다:
      • Dublin, 아일랜드, D24 NR0A
        • 모병
        • Tallaght University Hospital
        • 수석 연구원:
          • Helen Enright
        • 연락하다:
      • Dublin, 아일랜드, D05 DK31
        • 모병
        • Beaumont Hospital
        • 수석 연구원:
          • Philip Murphy
        • 연락하다:
      • Dublin, 아일랜드, DO4 T6F4
        • 모병
        • St Vincent's University Hospital (SVUH)
        • 수석 연구원:
          • Claire Andrews
        • 연락하다:
      • Limerick, 아일랜드, V94 F858
        • 모병
        • University Hospital Limerick
        • 연락하다:
        • 수석 연구원:
          • Cian McEllistrim
  • 영국
      • Birmingham, 영국, B15 2TH
        • 모병
        • Queen Elizabeth Hospital Birmingham
        • 수석 연구원:
          • Vidhya Murthy
        • 연락하다:
      • Cambridge, 영국, CB2 0QQ
        • 모병
        • Addenbrooke's Hospital
        • 수석 연구원:
          • Duncan Brian
        • 연락하다:
      • Leeds, 영국, LS9 7TF
        • 모병
        • St James's University Hospital
        • 연락하다:
        • 수석 연구원:
          • Catherine Cargo
      • London, 영국, SE5 9RS
        • 모병
        • King's College Hospital
        • 수석 연구원:
          • Austin Kulasekararaj
        • 연락하다:
      • London, 영국, W1G 6AD
        • 모병
        • Sarah Cannon Research Institute (SCRI)
        • 수석 연구원:
          • Jennifer O'Sullivan (Dillon)
        • 연락하다:
      • Manchester, 영국, M20 4BX
        • 모병
        • The Christie NHS Foundation Trust
        • 수석 연구원:
          • Daniel Wiseman
        • 연락하다:
      • Nottingham, 영국, NG5 1PB
        • 모병
        • Nottingham City Hospital
        • 수석 연구원:
          • Jennifer Byrne
        • 연락하다:
      • Oxford, 영국, OX3 7LE
        • 모병
        • Churchill Hospital
        • 연락하다:
        • 수석 연구원:
          • Oni Chowdhury
    • Aberdeen City
      • Aberdeen, Aberdeen City, 영국, AB25 2ZN
        • 모병
        • Aberdeen Royal Infirmary
        • 수석 연구원:
          • Dominic Culligan
        • 연락하다:
    • Denbighshire
      • Rhyl, Denbighshire, 영국, LL18 5UJ
    • Leics
      • Leicester, Leics, 영국, LE1 5WW
        • 모병
        • University Hospitals of Leicester
        • 수석 연구원:
          • Matthew Lee
        • 연락하다:
    • Lincolnshire
      • Lincoln, Lincolnshire, 영국, LN2 5QY
        • 모병
        • Lincolnshire Community and Hospitals NHS group
        • 수석 연구원:
          • Ciro Rinaldi
        • 연락하다:
    • Tyne and Wear
      • High Heaton, Tyne and Wear, 영국, NE7 7DN
        • 모병
        • The Newcastle Upon Tyne University Hospitals Foundation Trust
        • 연락하다:
        • 수석 연구원:
          • Michelle Lannon
      • Sunderland, Tyne and Wear, 영국, SR4 7TP
        • 아직 모집하지 않음
        • South Tyneside and Sunderland Foundation Trust
        • 수석 연구원:
          • Scott Marshall
        • 연락하다:
  • 이스라엘
      • Jerusalem, 이스라엘, 9112001
        • 모병
        • Hadassah Medical Center, Department of Hematology
        • 연락하다:
        • 수석 연구원:
          • Revital Saban
      • Petah Tikva, 이스라엘, 49100
        • 모병
        • Rabin Medical Center, Davidoff Cancer Center, Hemato-Oncology Institute
        • 수석 연구원:
          • Ofir Wolach
        • 연락하다:
      • Ramat Gan, 이스라엘, 5266202
        • 모병
        • Chaim Sheba Medical Center, Department of Hematology, Myelodysplastic Syndromes Center
        • 수석 연구원:
          • Drorit Merkel
        • 연락하다:
      • Tel Aviv, 이스라엘, 6423906
        • 모병
        • The Tel Aviv Sourasky Medical Center, Department of Hematology and Bone Marrow Transplantation, Leukemia Service
        • 수석 연구원:
          • Yakir Moshe
        • 연락하다:
  • 이탈리아
      • Florence, 이탈리아, 50134
        • 모병
        • Careggi University Hospital
        • 수석 연구원:
          • Valeria Santini
        • 연락하다:
      • Milan, 이탈리아, 20122
        • 모병
        • Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
        • 수석 연구원:
          • Bruno Fattizzo
        • 연락하다:
      • Pavia, 이탈리아, 27100
        • 모병
        • Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology
        • 연락하다:
        • 수석 연구원:
          • Luca Malcovati
      • Reggio Calabria, 이탈리아, 89133
        • 모병
        • Granda Ospedale Metropolitano 'Bianchi-Melacrino-Morelli'
        • 연락하다:
        • 수석 연구원:
          • Caterina Alati
      • Rome, 이탈리아, 00133
        • 모병
        • Foundation PTV - Polyclinic Tor Vergata
        • 수석 연구원:
          • Maria Teresa Voso
        • 연락하다:
      • Rozzano, 이탈리아, 20089
        • 모병
        • Clinical Institute Humanitas, IRCCS
        • 수석 연구원:
          • Matteo Giovanni Della Porta
        • 연락하다:
      • Turin, 이탈리아, 10060
        • 모병
        • Institute of Cancer Research and Treatment of Candiolo
        • 수석 연구원:
          • Elena Crisa
        • 연락하다:
    • AN
      • Ancona, AN, 이탈리아, 60126
        • 모병
        • Aou Delle Marche
        • 수석 연구원:
          • Antonella Poloni
        • 연락하다:
    • Piedmont
      • Turin, Piedmont, 이탈리아, 10128
        • 모병
        • AO Ordine Mauriziano
        • 수석 연구원:
          • Daniela Cilloni
        • 연락하다:
  • 인도
      • Delhi, 인도, 110085
        • 아직 모집하지 않음
        • Rajiv Gandhi Cancer Institute & Research Centre
        • 연락하다:
        • 수석 연구원:
          • Dinesh Bhurani
      • Gūrgaon, 인도, 122018
        • 모병
        • Medanta the Medicity
        • 연락하다:
        • 수석 연구원:
          • Nitin Sood
    • Gujarat
      • Ahmedabad, Gujarat, 인도, 380009
        • 모병
        • Heamto Oncology Clinic Ahmedabad Pvt. Ltd.
        • 연락하다:
        • 수석 연구원:
          • Sandip Shah
      • Ahmedabad, Gujarat, 인도, 382428
        • 모병
        • Apollo Hospital International Ltd
        • 연락하다:
        • 수석 연구원:
          • Velu Nair
    • Kerala
      • Ernākulam, Kerala, 인도, 682041
        • 아직 모집하지 않음
        • Amrita Institute of Medical Sciences
        • 연락하다:
        • 수석 연구원:
          • Neeraj Siddharthan
    • Maharashtra
      • Mumbai, Maharashtra, 인도, 400012
        • 아직 모집하지 않음
        • Tata Memorial Centre
        • 연락하다:
        • 수석 연구원:
          • Alok Shetty
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, 인도, 110029
        • 모병
        • All India Institute of Medical Science
        • 연락하다:
        • 수석 연구원:
          • Tulika Seth
    • Punjab
      • Ludhiana, Punjab, 인도, 380006
        • 모병
        • Christian Medical College, Ludhianana
        • 연락하다:
        • 수석 연구원:
          • Joseph John
    • Tamil Nadu
      • Vellore, Tamil Nadu, 인도, 632004
        • 모병
        • Christian Medical College
        • 연락하다:
        • 수석 연구원:
          • Biju George
    • Uttar Pradesh
      • Ghaziabad, Uttar Pradesh, 인도, 201012
        • 아직 모집하지 않음
        • Max Super Speciality Hospital Vaishali (A Unit Of Crosslay Remedies Ltd.)
        • 연락하다:
        • 수석 연구원:
          • Pradeep Kumar
    • West Bengal
      • Kolkata, West Bengal, 인도, 700014
        • 모병
        • NRS Medical College and Hospital
        • 연락하다:
        • 수석 연구원:
          • Tuphan Kanti Dolai
      • Kolkata, West Bengal, 인도, 700156
        • 모병
        • Tata Medical Center, Kolkata
        • 연락하다:
        • 수석 연구원:
          • Arijit Nag
  • 체코
      • Brno, 체코, 625 00
        • 모병
        • University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
        • 수석 연구원:
          • Jiri Mayer
        • 연락하다:
      • Hradec Králové, 체코, 500 05
        • 모병
        • University Hospital Hradec Kralove, 4th Internal Clinic of Hematology
        • 연락하다:
        • 수석 연구원:
          • Petra Belohlavkova
      • Ostrava, 체코, 70852
        • 모병
        • Charles University General Hospital
        • 수석 연구원:
          • Anna Jonasova
        • 연락하다:
      • Ostrava, 체코, 70852
        • 모병
        • University Hospital Ostrava and Faculty of Medicine, University of Ostrava
        • 연락하다:
        • 수석 연구원:
          • Zdenek Koristek
      • Prague, 체코, 100 00
        • 모병
        • University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
        • 연락하다:
        • 수석 연구원:
          • Olga Cerna
      • Prague, 체코, 12800
        • 모병
        • Institute of Hematology and Blood Transfusion, Division of Training and Development
        • 수석 연구원:
          • Marketa Stastna-Markova
        • 연락하다:
  • 칠레
      • Santiago, 칠레, 7500653
        • 모병
        • SAGA Clinical Research Center SpA
        • 수석 연구원:
          • Ada Hernandez
        • 연락하다:
      • Santiago, 칠레, 7580206
        • 모병
        • Clinic Inmunocel
        • 연락하다:
        • 수석 연구원:
          • Jose Vinuela
      • Santiago, 칠레, 8320000
        • 모병
        • Center for Clinical Studies and Medical Research (CECIM)
        • 수석 연구원:
          • Alexander Arellano
        • 연락하다:
    • Biobio
      • Concepción, Biobio, 칠레, 4070356
        • 모병
        • Dr. Guillermo Grant Benavente - Concepcion Regional Hospital
        • 수석 연구원:
          • Monica Romero
        • 연락하다:
    • Coquimbo Region
      • La Serena, Coquimbo Region, 칠레, 1720430
        • 모병
        • IC La Serena Research
        • 수석 연구원:
          • Cleiden Villegas
        • 연락하다:
  • 캐나다
    • Alberta
      • Edmonton, Alberta, 캐나다, T6G 2B7
        • 모병
        • University of Alberta Hospital
        • 연락하다:
        • 수석 연구원:
          • Nancy Zhu
    • British Columbia
      • Vancouver, British Columbia, 캐나다, V6Z 2A5
        • 모병
        • Providence Hematology - Vancouver
        • 연락하다:
        • 수석 연구원:
          • Heather Leitch
    • Nova Scotia
      • Halifax, Nova Scotia, 캐나다, B3H 1V7
        • 모병
        • Nova Scotia Health Authority, Centre for Clinical Research
        • 연락하다:
        • 수석 연구원:
          • Amy Trottier
    • Ontario
      • London, Ontario, 캐나다, N6A 4L6
        • 모병
        • London Health Sciences Centre
        • 수석 연구원:
          • Lalit Saini
        • 연락하다:
      • Toronto, Ontario, 캐나다, M5G 2M9
        • 모병
        • Princess Margaret Cancer Centre
        • 연락하다:
        • 수석 연구원:
          • Karen Yee
      • Toronto, Ontario, 캐나다, M4N 3M5
        • 모병
        • Sunnybrook Research Institute, Odette Cancer Center
        • 수석 연구원:
          • Rena Buckstein
        • 연락하다:
  • 태국
      • Bangkok, 태국, 10330
        • 모병
        • King Chulalongkorn Memorial Hospital
        • 연락하다:
        • 수석 연구원:
          • Noppacharn Uaprasert
      • Bangkok, 태국, 10400
        • 모병
        • Ramathibodi Hospital
        • 연락하다:
        • 수석 연구원:
          • Piyajaroenkij Thanakrit
      • Bangkok, 태국, 10400
        • 모병
        • Rajavithi Hospital
        • 연락하다:
        • 수석 연구원:
          • Kunapa Iam-arunthai
      • Bangkok, 태국, 74210
        • 모병
        • Banphaeo General Hospital
        • 수석 연구원:
          • Busakorn Sae-Aeng
        • 연락하다:
      • Chiang Mai, 태국, 50200
        • 모병
        • Maharaj Nakorn Chiangmai Hospital
        • 연락하다:
        • 수석 연구원:
          • Thanawat Rattanathammethee
  • 터키 (Türkiye)
      • Adana, 터키 (Türkiye), 01370
        • 모병
        • Adana City Hospital
        • 연락하다:
        • 수석 연구원:
          • Elif Suyani
      • Ankara, 터키 (Türkiye), 06170
        • 모병
        • Ankara Etlik City Hospital
        • 수석 연구원:
          • Merih Kizil Cakar
        • 연락하다:
      • Ankara, 터키 (Türkiye), 06600
        • 아직 모집하지 않음
        • Ankara University Medical Faculty Cebeci Hospital
        • 수석 연구원:
          • Selami Toprak
        • 연락하다:
      • Antalya, 터키 (Türkiye), 07100
        • 모병
        • Antalya Education and Training Hospital
        • 수석 연구원:
          • Volkan Karakus
        • 연락하다:
      • Mersin, 터키 (Türkiye), 33200
        • 모병
        • Mersin Medicalpark Hospital
        • 수석 연구원:
          • Anil Tombak
        • 연락하다:
      • Sakarya, 터키 (Türkiye), 54290
        • 모병
        • Sakarya University Medical Faculty Hospital
        • 수석 연구원:
          • Cenk Sunu
        • 연락하다:
      • Samsun, 터키 (Türkiye), 55139
        • 모병
        • Ondokuz Mayis University School of Medicine, Department of Hematology
        • 연락하다:
        • 수석 연구원:
          • Engin Kelkitli
  • 페루
      • Bellavista, 페루, 07016
        • 아직 모집하지 않음
        • Daniel Alcides Carrion National Hospital
        • 수석 연구원:
          • Jose Chinen Pemberton
        • 연락하다:
      • Lima, 페루, 15038
        • 아직 모집하지 않음
        • National Institute of Neoplastic Diseases
        • 연락하다:
        • 수석 연구원:
          • Jule Vasquez
    • Jesus Maria
      • Lima, Jesus Maria, 페루, 15073
        • 아직 모집하지 않음
        • Edgardo Rebagliati Martins National Hospital
        • 연락하다:
        • 수석 연구원:
          • Lourdes Aranda
    • La Molina
      • Lima, La Molina, 페루, 15023
        • 모병
        • Anglo American Clinic
        • 수석 연구원:
          • Antonio Carrasco
        • 연락하다:
    • San Isidro Lima
      • Lima, San Isidro Lima, 페루, 02002
        • 모병
        • IPOR: Peruvian Institute of Oncology & Radiotherapy
        • 수석 연구원:
          • Maria Vera Vasquez
        • 연락하다:
  • 폴란드
      • Katowice, 폴란드, 40-519
        • 모병
        • Pratia Oncology Katowice
        • 수석 연구원:
          • Sebastian Grosicki
        • 연락하다:
      • Lodz, 폴란드, 93-513
        • 모병
        • Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz, General Hematology Unit
        • 수석 연구원:
          • Tadeusz Robak
        • 연락하다:
      • Olsztyn, 폴란드, 10-228
        • 모병
        • Clinical Hospital Of The Ministry Of Internal Affairs And Administration With Warmia And Mazury Oncology Centre In Olsztyn, Clinical Department of Hematology and Internal Medicine with Bone Marrow Transplantation Center
        • 수석 연구원:
          • Janusz Halka
        • 연락하다:
    • Greater
      • Poznan, Greater, 폴란드, 60-192
        • 모병
        • Pratia Poznan
        • 연락하다:
        • 수석 연구원:
          • Anna Hoppe
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, 폴란드, 50-019
        • 모병
        • Pratia Onkologia Wroclaw
        • 연락하다:
        • 수석 연구원:
          • Justyna Rybka
  • 프랑스
      • Nice, 프랑스, 06200
        • 모병
        • Archet 1 and 2 hospital
        • 수석 연구원:
          • Thomas Cluzeau
        • 연락하다:
      • Paris, 프랑스, 75010
        • 모병
        • Saint-Louis Hospital
        • 수석 연구원:
          • Lionel Ades
        • 연락하다:
      • Poitiers, 프랑스, 86000
        • 모병
        • Poitiers University Hospital Center - Miletrie Site
        • 수석 연구원:
          • Jose Miguel Torregrosa-Diaz
        • 연락하다:
      • Toulouse, 프랑스, 31059
  • 헝가리
      • Budapest, 헝가리, H-1088
        • 모병
        • Semmelweis University, Department of Internal Medicine and Haematology, Division of Hematology
        • 수석 연구원:
          • Zsolt Nagy
        • 연락하다:
      • Debrecen, 헝가리, 4032
        • 모병
        • University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology
        • 수석 연구원:
          • Arpad Illes
        • 연락하다:
      • Kaposvár, 헝가리, H-7400
        • 모병
        • Mor Kaposi General Hospital, Department of Hematology
        • 연락하다:
        • 수석 연구원:
          • Miklos Egyed
      • Nyíregyháza, 헝가리, 4400
        • 모병
        • Szabolcs-Szatmar-Bereg County Teaching Hospital, Department of Hematology
        • 수석 연구원:
          • Laszlo Rejto
        • 연락하다:
      • Székesfehérvár, 헝가리, H-8000
        • 모병
        • Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine III, Hematology
        • 연락하다:
        • 수석 연구원:
          • Arpad Szomor
  • 호주
    • Australian Capital Territory
      • Garran, Australian Capital Territory, 호주, 2605
        • 아직 모집하지 않음
        • The Canberra Hospital
        • 수석 연구원:
          • Philip Choi
        • 연락하다:
    • New South Wales
      • Sydney, New South Wales, 호주, 2145
    • Queensland
      • Douglas, Queensland, 호주, 4814
        • 모병
        • Townsville University Hospital
        • 수석 연구원:
          • Joel Wight
        • 연락하다:
    • South Australia
      • Adelaide, South Australia, 호주, 5000
        • 모병
        • Royal Adelaide Hospital
        • 연락하다:
        • 수석 연구원:
          • Devendra Hiwase
      • Adelaide, South Australia, 호주, 5042
        • 모병
        • Flinders Medical Centre
        • 연락하다:
        • 수석 연구원:
          • Ashanka Beligaswatte
    • Victoria
      • Box Hill, Victoria, 호주, 3128
      • Fitzroy, Victoria, 호주, 3065
        • 모병
        • St Vincent's Hospital (Melbourne) Ltd
        • 연락하다:
        • 수석 연구원:
          • ShuhYing Tan
      • Melbourne, Victoria, 호주, 3004
        • 아직 모집하지 않음
        • Alfred Health
        • 수석 연구원:
          • Shaun Fleming
        • 연락하다:
      • Parkville, Victoria, 호주, 3000
        • 모병
        • Peter MacCallum Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Lynette Chee

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information and/or protected personal data in accordance with national and local study participant data protections and privacy regulations.

  • Male or female greater than or equal to (≥)18 years of age at the time of signing informed consent.

  • Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow sample, read by an independent central reader to confirm diagnosis at Screening) according to the World Health Organization 2016 classification that meets the International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease. In cases where a local bone marrow (BM) assessment establishing an MDS diagnosis was conducted within 12 weeks prior to informed consent form (ICF) signature, the associated local BM samples and/or reports may be permitted.

  • Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either:

    a. LTB, defined as 4 to 7 RBC units per 16 weeks; or b. HTB, defined as ≥8 RBC units per 16 weeks; and c. For all participants: i. Only transfusion events for a pretransfusion hemoglobin (Hgb) lesser than (<)10 grams per deciliter (g/dL) are counted toward eligibility; ii. At least 1 transfusion event in each 8-week period and a minimum of 2 transfusion events separated by ≥7 days within the 16-week period immediately preceding randomization; and iii. No consecutive 56-day period can be RBC transfusion-free during the 16-week period immediately preceding randomization.

  • Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to respond to ESA treatment, defined as follows:

    a. Refractory to prior ESA treatment: documentation of nonresponse or a response that was no longer maintained with a prior ESA-containing regimen, either as a single agent or combination (e.g., with granulocyte colony-stimulating factor [G-CSF]); ESA regimen must have been either: i. Recombinant human erythropoietin (EPO) ≥30,000 international units per week (IU/week) for ≥8 doses or equivalent; or ii. Darbepoetin alpha ≥500 micrograms (μg) every 3 weeks for ≥3 doses or ≥ 120 μg every week for ≥ 8 doses or equivalent.

    b. Intolerant to prior ESA treatment: documentation of discontinuation of a prior ESA-containing regimen, either as a single agent or combination (e.g., with G-CSF), at any time after introduction due to intolerance or an AE.

    c. Unlikely to respond to ESA treatment: low chance of response to ESA based on an endogenous serum EPO level greater than (>)200 units per liter (U/L).

  • Less than 5 percent (%) blasts in an evaluable bone marrow sample collected at Screening.

  • Eastern Cooperative Oncology Group performance status of 0 to 2.

  • Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception.

  • In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the protocol (e.g., all study procedures, return for follow-up visits).

Exclusion Criteria:

  • Del(5q) MDS, secondary MDS (MDS with a documented history of prior exposure to chemotherapy, radiotherapy, or other leukemogenic agents that is considered causally related to the development of MDS).

  • Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and/or folate).

  • Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization.

  • Clinically significant cardiovascular disease defined as:

    1. New York Heart Association heart disease class III or IV;
    2. Fridericia corrected QT (QTcF) interval >500 milliseconds during Screening;
    3. Presence of uncontrolled hypertension defined as mean systolic blood pressure ≥160 millimeters of mercury (mm Hg) or diastolic blood pressure ≥100 mm Hg during Screening; or
    4. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before Screening.

  • Known ejection fraction <35%, confirmed by a local echocardiogram performed during Screening, or a previously performed echocardiogram if collected within 6 months before Screening.

  • Child-Pugh class C hepatic impairment.

  • Stroke, deep vein thrombosis, or pulmonary embolism within 6 months before Screening.

  • Any known history of acute myeloid leukemia (AML).

  • Prior history of malignancies, other than MDS, unless participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for ≥ 2 years. However, 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 tumor, node, metastasis [TNM] clinical staging system).
    5. Early papillary thyroid cancer (stage I [T1-T2, N0, M0]).

  • History of solid organ or bone marrow transplantation.

  • Active infection requiring intravenous treatment (e.g., antibiotics, antifungals, or antivirals) within 28 days, or oral treatment within 14 days before randomization.

  • Active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Participants with a history of HIV infection may be enrolled if they are receiving antiretroviral therapy and have a documented CD4+ T cell count > 200 cells per microliter (cells/μL) at screening. Participants without known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.

  • Body mass index ≥ 40 kilograms per meter square (kg/m^2).

  • Major surgery within 28 days before randomization.

  • History of allergy/anaphylaxis to investigational medicinal product (IMP) excipients (refer to the current elritercept IB for a list of excipients) or recombinant proteins.

  • Prior use of elritercept, luspatercept, or sotatercept.

  • Prior use of hypomethylating agents (HMAs), isocitrate dehydrogenase inhibitor, lenalidomide, imetelstat, or immunosuppressive therapy given for treatment of MDS.

  • Iron chelation therapy initiated within 8 weeks before randomization. Participants on stable or decreasing doses of iron chelation therapy for ≥ 8 weeks are allowed.

  • Vitamin B12 or folate therapy initiated within 4 weeks before randomization. Participants on stable replacement doses for ≥ 4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.

  • Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥ 8 weeks are allowed.

  • High-dose systemic corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone lesser than or equal to (≤) 10 milligrams per day (mg/day) or corticosteroid equivalent for ≥ 4 weeks are allowed.10 mg/day or corticosteroid equivalent for ≥ 4 weeks are allowed.

  • Treatment with any investigational drug within 28 days before Screening or, if the half-life of the product is known, within 5 times the half-life before Screening, whichever is longer.

  • Ongoing participation in another interventional clinical study.

  • Serum EPO level >500 U/L.

  • Platelet count ≥800 × 10^9 per liter (/L) or ≤25 × 10^9/L.

  • Absolute neutrophil count ≤ 500 per microliter (/µL).

  • Serum aspartate aminotransferase or alanine aminotransferase ≥3 × the upper limit of normal (ULN).

  • Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome. Participants with known history of Gilbert syndrome with unconjugated bilirubin < 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.

  • Ferritin ≤ 50 micrograms per litre (μg/L).

  • Folate ≤2.0 nanograms per milliliter (ng/mL).

  • Vitamin B12 ≤200 picograms per milliliter (pg/mL).

  • Estimated glomerular filtration rate <30 milliliters per minute per 1.73 meter square (mL/min/1.73m^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Collaboration equation.

  • Pregnant or lactating female.

  • Any other condition not specifically noted above that, in the opinion of the Investigator, would preclude the participant from participating in the study or could confound interpretation of data from the study.

  • Investigational site staff members directly involved in the conduct of the study and site staff members otherwise supervised by the Investigator, employees of the Sponsor or CRO directly involved in the conduct of the study, or immediate family members (defined as a spouse, parent, child, or sibling, whether biological or legally adopted).

  • For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults (per applicable French law [Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1]).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Elritercept

Participants will be administered elritercept (TAK-226, KER-050), subcutaneously every 4 weeks, up to 48 weeks or until the end of treatment period.
의약품: Elritercept

Elritercept (TAK-226, KER-050) administered subcutaneously every 4 weeks.

다른 이름들:
  • KER-050
  • 타크-226
위약 비교기: Placebo

Participants will be administered elritercept (TAK-226, KER-050) matching-placebo, subcutaneously every 4 weeks, up to 48 weeks or until the end of treatment period.
의약품: Placebo

Elritercept (TAK-226, KER-050) matching-placebo administered subcutaneously every 4 weeks.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants Achieving Transfusion Independence (TI) for ≥8 Weeks
기간: Baseline through Week 24

Transfusion independence is defined as the absence of any red blood cells (RBC) transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24.
Baseline through Week 24

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants Achieving TI for ≥24 Weeks
기간: Baseline through Week 48

Transfusion independence is defined as the absence of any RBC transfusions in a period of at least 24 weeks after the first dose of the study treatment through week 48.
Baseline through Week 48
Percentage of Participants with High-transfusion Burden (HTB) Achieving TI for ≥8 weeks
기간: Baseline through Week 24

Transfusion independence is defined as the absence of any RBC transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24.
Baseline through Week 24
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
기간: From the time of signing the informed consent form through 60 days after the last dose of study treatment, approximately 6 years

An adverse event (AE) is defined as any untoward medical occurrence, in a clinical study participant administered a medicinal product, that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not it is related to study treatment. A TEAE is defined as an AE that commences on or after the first dose of the study treatment and within 60 days after the last dose of the study treatment, or analysis cutoff date, whichever is earlier. An SAE is any untoward medical occurrence that, at any dose: results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.
From the time of signing the informed consent form through 60 days after the last dose of study treatment, approximately 6 years
Change from Baseline in Clinical Laboratory Values, Vital Signs, and Electrocardiograms (ECGs)
기간: From the time of signing the informed consent form through safety follow-up, approximately 16 months

Change from baseline in clinical laboratory values, vital signs, and ECGs will be assessed.
From the time of signing the informed consent form through safety follow-up, approximately 16 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Takeda

수사관

  • 연구 책임자: Study Director, Takeda

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 5월 6일

기본 완료 (추정된)

2028년 9월 15일

연구 완료 (추정된)

2032년 3월 5일

연구 등록 날짜

최초 제출

2024년 7월 5일

QC 기준을 충족하는 최초 제출

2024년 7월 11일

처음 게시됨 (실제)

2024년 7월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 5일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • KER-050-D301
  • 2024-516009-22-00 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다