A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions

May 12, 2026 updated by: Takeda

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants With Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 RS status (RS-positive versus non-RS) and baseline transfusion burden (LTB versus 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 3 years after the last dose, whichever is longer, or until a participant is deceased, is lost to follow-up, withdraws consent, or the study closes, whichever is earliest.

Study Type

Interventional

Enrollment (Estimated)

225

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Not yet recruiting
        • The Canberra Hospital
        • Principal Investigator:
          • Philip Choi
        • Contact:
    • New South Wales
      • Sydney, New South Wales, Australia, 2145
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • Recruiting
        • Townsville University Hospital
        • Principal Investigator:
          • Joel Wight
        • Contact:
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
        • Principal Investigator:
          • Devendra Hiwase
      • Adelaide, South Australia, Australia, 5042
        • Recruiting
        • Flinders Medical Centre
        • Contact:
        • Principal Investigator:
          • David Beligaswatte
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • Box Hill Hospital
        • Contact:
        • Principal Investigator:
          • Stephen Ting
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • St Vincent's Hospital (Melbourne) Ltd
        • Principal Investigator:
          • ShuhYing Tan
        • Contact:
      • Melbourne, Victoria, Australia, 3004
        • Not yet recruiting
        • Alfred Health
        • Principal Investigator:
          • Shaun Fleming
        • Contact:
      • Parkville, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Center
        • Contact:
        • Principal Investigator:
          • Lynette Chee
  • Brazil
      • Rio de Janeiro, Brazil, 22775-001
      • São Paulo, Brazil, 01323-900
        • Recruiting
        • Portuguese Charity of Sao Paulo, Clinical Hematology / Oncology Center
        • Contact:
        • Principal Investigator:
          • Phillip Scheinberg
      • São Paulo, Brazil, 11075-900
        • Not yet recruiting
        • Santa Casa of Mercy of Santos
        • Principal Investigator:
          • Elaine Mancilha
        • Contact:
      • São Paulo, Brazil, 01509-900
        • Recruiting
        • Hospital A.C.Camargo ("Antonio Prudente" Foundation)
        • Principal Investigator:
          • Marina Nascimento
        • Contact:
    • Paraná
      • Curitiba, Paraná, Brazil, 81520-060
        • Not yet recruiting
        • Hosptial Erasto Gaertner
        • Contact:
        • Principal Investigator:
          • Eduardo Munhoz
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Recruiting
        • Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
        • Principal Investigator:
          • Mariza Schaan
        • Contact:
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Recruiting
        • Porto Alegre Clinical Hospital (HCPA)
        • Principal Investigator:
          • Laura Maria Fogliatto
        • Contact:
      • Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
        • Recruiting
        • Hospital Mae de Deus, Clinical Research Unit - Cancer Institute
        • Principal Investigator:
          • Marcelo Capra
        • Contact:
    • Santa Catarina
      • Joinville, Santa Catarina, Brazil, 89201-260
        • Not yet recruiting
        • Instituto Joinvilense de Hematologia E Oncologia
        • Contact:
        • Principal Investigator:
          • Lacerda Marcelo
    • São Paulo
      • Jaú, São Paulo, Brazil, 17210-080
      • Santo André, São Paulo, Brazil, 09060-650
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Sao Jose do Rio Preto Regional Faculty of Medicine Foundation
        • Principal Investigator:
          • Mariana Buka
        • Contact:
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD)
        • Contact:
        • Principal Investigator:
          • Pencho Georgiev
      • Sofia, Bulgaria, 1431
        • Recruiting
        • University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology
        • Principal Investigator:
          • Atanas Radinoff
        • Contact:
      • Sofia, Bulgaria, 1606
        • Recruiting
        • Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical Academy, Clinic of Hematology
        • Contact:
        • Principal Investigator:
          • Viktoria Barbukova
      • Sofia, Bulgaria, 1797
        • Recruiting
        • Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology
        • Contact:
        • Principal Investigator:
          • Tanya Yankova
      • Varna, Bulgaria, 9010
        • Not yet recruiting
        • University Multiprofile Hospital for Active Treatment "Sveta Marina", Clinic of Clinical Hematology
        • Principal Investigator:
          • Ilina Micheva
        • Contact:
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • University of Alberta Hospital
        • Contact:
        • Principal Investigator:
          • Nancy Zhu
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2A5
        • Recruiting
        • Providence Hematology - Vancouver
        • Contact:
        • Principal Investigator:
          • Heather Leitch
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Recruiting
        • Nova Scotia Health Authority, Centre for Clinical Research
        • Contact:
        • Principal Investigator:
          • Amy Trottier
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Recruiting
        • London Health Sciences Centre
        • Principal Investigator:
          • Lalit Saini
        • Contact:
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
        • Principal Investigator:
          • Karen Yee
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute, Odette Cancer Center
        • Principal Investigator:
          • Rena Buckstein
        • Contact:
  • Chile
      • Santiago, Chile, 7500653
        • Recruiting
        • SAGA Clinical Research Center SpA
        • Principal Investigator:
          • Ada Hernandez
        • Contact:
      • Santiago, Chile, 7580206
        • Recruiting
        • Clinic Inmunocel
        • Principal Investigator:
          • Alejandro Berkovits
        • Contact:
      • Santiago, Chile, 8320000
        • Recruiting
        • Center for Clinical Studies and Medical Research (CECIM)
        • Principal Investigator:
          • Alexander Arellano
        • Contact:
    • Biobio
      • Concepción, Biobio, Chile, 4070356
        • Recruiting
        • Dr. Guillermo Grant Benavente - Concepcion Regional Hospital
        • Principal Investigator:
          • Monica Romero
        • Contact:
    • Coquimbo Region
      • La Serena, Coquimbo Region, Chile, 1720430
        • Recruiting
        • IC La Serena Research
        • Principal Investigator:
          • Cleiden Villegas
        • Contact:
  • Czechia
      • Brno, Czechia, 625 00
        • Not yet recruiting
        • University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
        • Principal Investigator:
          • Jiri Mayer
        • Contact:
      • Hradec Králové, Czechia, 500 05
        • Recruiting
        • University Hospital Hradec Kralove, 4th Internal Clinic of Hematology
        • Contact:
        • Principal Investigator:
          • Petra Belohlavkova
      • Ostrava, Czechia, 70852
        • Not yet recruiting
        • University Hospital Ostrava and Faculty of Medicine, University of Ostrava
        • Contact:
        • Principal Investigator:
          • Zdenek Koristek
      • Prague, Czechia, 12800
        • Not yet recruiting
        • Institute of Hematology and Blood Transfusion, Division of Training and Development
        • Principal Investigator:
          • Marketa Stastna-Markova
        • Contact:
      • Prague, Czechia, 100 00
        • Recruiting
        • University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
        • Contact:
        • Principal Investigator:
          • Olga Cerna
  • France
      • Nice, France, 06200
        • Recruiting
        • Archet 1 and 2 hospital
        • Principal Investigator:
          • Thomas Cluzeau
        • Contact:
      • Paris, France, 75010
        • Recruiting
        • Saint-Louis Hospital
        • Principal Investigator:
          • Lionel Ades
        • Contact:
      • Poitiers, France, 86000
        • Recruiting
        • Poitiers University Hospital Center - Miletrie Site
        • Principal Investigator:
          • Jose Miguel Torregrosa-Diaz
        • Contact:
      • Toulouse, France, 31059
        • Recruiting
        • IUCT-Oncopole
        • Contact:
        • Principal Investigator:
          • Thibault Comont
  • Germany
      • Berlin, Germany, 12203
        • Not yet recruiting
        • Charité Universitätsmedizin Berlin
        • Principal Investigator:
          • Kathrin Rieger
        • Contact:
      • Berlin, Germany, 10715
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Not yet recruiting
        • University Hospital Bronn
        • Principal Investigator:
          • Karin Mayer
        • Contact:
      • Düsseldorf, North Rhine-Westphalia, Germany, 40479
        • Recruiting
        • Marien Hospital Duesseldorf GmbH, Clinic for Oncology, Hematology and Palliative Medicine
        • Contact:
        • Principal Investigator:
          • Aristoteles Giagounidis
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • University Hospital Leipzig, Clinic and Policlinic for Internal Medicine I Haematology and Stem Cell Therapy, Medical Oncology, Haemostaseology
        • Principal Investigator:
          • Dominic Brauer
        • Contact:
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06120
        • Recruiting
        • University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
        • Contact:
        • Principal Investigator:
          • Haifa Al-Ali
      • Magdeburg, Saxony-Anhalt, Germany, 39120
        • Not yet recruiting
        • University Clinic of Hematology, Oncology and Cell Therapy
        • Principal Investigator:
          • Berisha Mirjeta
        • Contact:
  • Hungary
      • Budapest, Hungary, H-1088
        • Recruiting
        • Semmelweis University, Department of Internal Medicine and Haematology, Division of Hematology
        • Principal Investigator:
          • Zsolt Nagy
        • Contact:
      • Debrecen, Hungary, 4032
        • Recruiting
        • University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology
        • Principal Investigator:
          • Arpad Illes
        • Contact:
      • Kaposvár, Hungary, H-7400
        • Recruiting
        • Mor Kaposi General Hospital, Department of Hematology
        • Contact:
        • Principal Investigator:
          • Miklos Egyed
      • Nyíregyháza, Hungary, 4400
        • Recruiting
        • Szabolcs-Szatmar-Bereg County Teaching Hospital, Department of Hematology
        • Principal Investigator:
          • Laszlo Rejto
        • Contact:
      • Székesfehérvár, Hungary, H-8000
        • Recruiting
        • Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine III, Hematology
        • Contact:
        • Principal Investigator:
          • Arpad Szomor
  • India
      • Chandigarh, India, 160 012
        • Not yet recruiting
        • Postgraduate Institute of Medical Education and Research
        • Contact:
        • Principal Investigator:
          • Pankaj Malhotra
      • Delhi, India, 110085
        • Not yet recruiting
        • Rajiv Gandhi Cancer Institute & Research Centre
        • Contact:
        • Principal Investigator:
          • Dinesh Bhurani
      • Gurgaon, India, 122018
        • Not yet recruiting
        • Medanta The Medicity
        • Contact:
        • Principal Investigator:
          • Nitin Sood
    • Gujarat
      • Ahmedabad, Gujarat, India, 382428
        • Not yet recruiting
        • Apollo Hospital International Ltd
        • Contact:
        • Principal Investigator:
          • Velu Nair
      • Ahmedabad, Gujarat, India, 380009
        • Recruiting
        • Heamto Oncology Clinic Ahmedabad Pvt. Ltd.
        • Contact:
        • Principal Investigator:
          • Sandip Shah
    • Kerala
      • Ernākulam, Kerala, India, 682041
        • Not yet recruiting
        • Amrita Institute of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Neeraj Siddharthan
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Not yet recruiting
        • Tata Memorial Centre
        • Contact:
        • Principal Investigator:
          • Alok Shetty
    • Punjab
      • Ludhiana, Punjab, India, 380006
        • Recruiting
        • Christian Medical College, Ludhianana
        • Contact:
        • Principal Investigator:
          • Joseph John
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632004
        • Recruiting
        • Christian Medical College
        • Contact:
        • Principal Investigator:
          • Biju George
    • Uttar Pradesh
      • Ghaziabad, Uttar Pradesh, India, 201012
        • Not yet recruiting
        • Max Super Speciality Hospital Vaishali (A Unit Of Crosslay Remedies Ltd.)
        • Contact:
        • Principal Investigator:
          • Pradeep Kumar
    • West Bengal
      • Kolkata, West Bengal, India, 700014
        • Not yet recruiting
        • NRS Medical College and Hospital
        • Contact:
        • Principal Investigator:
          • Tuphan Kanti Dolai
      • Kolkata, West Bengal, India, 700156
        • Not yet recruiting
        • Tata Medical Center, Kolkata
        • Contact:
        • Principal Investigator:
          • Arijit Nag
  • Ireland
      • Cork, Ireland, T12 DC4A
        • Not yet recruiting
        • Cork University Hospital
        • Principal Investigator:
          • Vitaliy Mykytiv
        • Contact:
      • Dublin, Ireland, D07 R2WY
        • Recruiting
        • Mater Misericordiae University Hospital
        • Principal Investigator:
          • Su Maung
        • Contact:
      • Dublin, Ireland, D24 NR0A
        • Recruiting
        • Tallaght University Hospital
        • Principal Investigator:
          • Helen Enright
        • Contact:
      • Dublin, Ireland, D05 DK31
        • Recruiting
        • Beaumont Hospital
        • Principal Investigator:
          • Philip Murphy
        • Contact:
      • Dublin, Ireland, DO4 T6F4
        • Recruiting
        • St Vincent's University Hospital (SVUH)
        • Principal Investigator:
          • Claire Andrews
        • Contact:
      • Limerick, Ireland, V94 F858
        • Not yet recruiting
        • University Hospital Limerick
        • Contact:
        • Principal Investigator:
          • Cian McEllistrim
  • Israel
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center, Department of Hematology
        • Contact:
        • Principal Investigator:
          • Revital Saban
      • Petah Tikva, Israel, 49100
        • Recruiting
        • Rabin Medical Center, Davidoff Cancer Center, Hemato-Oncology Institute
        • Principal Investigator:
          • Ofir Wolach
        • Contact:
      • Ramat Gan, Israel, 5266202
        • Recruiting
        • Chaim Sheba Medical Center, Department of Hematology, Myelodysplastic Syndromes Center
        • Principal Investigator:
          • Drorit Merkel
        • Contact:
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • The Tel Aviv Sourasky Medical Center, Department of Hematology and Bone Marrow Transplantation, Leukemia Service
        • Principal Investigator:
          • Yakir Moshe
        • Contact:
  • Italy
      • Florence, Italy, 50134
        • Recruiting
        • Careggi University Hospital
        • Principal Investigator:
          • Valeria Santini
        • Contact:
      • Milan, Italy, 20122
        • Recruiting
        • Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
        • Principal Investigator:
          • Bruno Fattizzo
        • Contact:
      • Pavia, Italy, 27100
        • Recruiting
        • Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology
        • Contact:
        • Principal Investigator:
          • Luca Malcovati
      • Reggio Calabria, Italy, 89133
        • Not yet recruiting
        • Granda Ospedale Metropolitano 'Bianchi-Melacrino-Morelli'
        • Contact:
        • Principal Investigator:
          • Caterina Alati
      • Rome, Italy, 00133
        • Recruiting
        • Foundation PTV - Polyclinic Tor Vergata
        • Contact:
        • Principal Investigator:
          • Maria Teresa Voso
      • Rozzano, Italy, 20089
        • Recruiting
        • Clinical Institute Humanitas, IRCCS
        • Principal Investigator:
          • Matteo Giovanni Della Porta
        • Contact:
      • Turin, Italy, 10060
        • Recruiting
        • Institute of Cancer Research and Treatment of Candiolo
        • Principal Investigator:
          • Elena Crisa
        • Contact:
    • AN
      • Ancona, AN, Italy, 60126
        • Not yet recruiting
        • Aou Delle Marche
        • Principal Investigator:
          • Antonella Poloni
        • Contact:
    • Piedmont
      • Turin, Piedmont, Italy, 10128
        • Not yet recruiting
        • AO Ordine Mauriziano
        • Principal Investigator:
          • Daniela Cilloni
        • Contact:
  • Lithuania
      • Kaunas, Lithuania, LT-50161
        • Recruiting
        • Hospital of Lithuanian University of Health Sciences Kauno Klinikos
        • Contact:
        • Principal Investigator:
          • Milda Rudzianskiene
      • Vilnius, Lithuania, LT-08406
        • Recruiting
        • Vilnius University Hospital Santaros Klinikos
        • Principal Investigator:
          • Andrius Degulys
        • Contact:
  • Peru
      • Bellavista, Peru, 07016
        • Not yet recruiting
        • Daniel Alcides Carrion National Hospital
        • Principal Investigator:
          • Jose Chinen Pemberton
        • Contact:
      • Lima, Peru, 15038
        • Not yet recruiting
        • National Institute of Neoplastic Diseases
        • Contact:
        • Principal Investigator:
          • Jule Vasquez
    • Jesus Maria
      • Lima, Jesus Maria, Peru, 15073
        • Not yet recruiting
        • Edgardo Rebagliati Martins National Hospital
        • Contact:
        • Principal Investigator:
          • Lourdes Aranda
    • La Molina
      • Lima, La Molina, Peru, 15023
        • Not yet recruiting
        • Anglo American Clinic
        • Principal Investigator:
          • Antonio Carrasco
        • Contact:
    • San Isidro Lima
      • Lima, San Isidro Lima, Peru, 02002
        • Recruiting
        • IPOR: Peruvian Institute of Oncology & Radiotherapy
        • Principal Investigator:
          • Maria Vera Vasquez
        • Contact:
  • Poland
      • Katowice, Poland, 40-519
        • Recruiting
        • Pratia Oncology Katowice
        • Principal Investigator:
          • Sebastian Grosicki
        • Contact:
      • Lodz, Poland, 93-513
        • Recruiting
        • Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz, General Hematology Unit
        • Principal Investigator:
          • Tadeusz Robak
        • Contact:
      • Olsztyn, Poland, 10-228
        • Recruiting
        • 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
        • Principal Investigator:
          • Janusz Halka
        • Contact:
    • Greater
      • Poznan, Greater, Poland, 60-192
        • Not yet recruiting
        • Pratia Poznań
        • Contact:
        • Principal Investigator:
          • Anna Hoppe
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-019
        • Not yet recruiting
        • Pratia Onkologia Wroclaw
        • Contact:
        • Principal Investigator:
          • Justyna Rybka
  • South Africa
      • Cape Town, South Africa, 7580
        • Recruiting
        • Haemalife
        • Contact:
        • Principal Investigator:
          • Michael Cass
      • Durban, South Africa, 4091
        • Recruiting
        • Capital Haematology Hospital
        • Principal Investigator:
          • Jaimendra Singh
        • Contact:
      • Johannesburg, South Africa, 2193
        • Recruiting
        • Charlotte Maxeke Johannesburg Academic Hospital, Hemophilia Comprehensive Care Center
        • Contact:
        • Principal Investigator:
          • Johnny Mahlangu
      • Pretoria, South Africa, 0181
        • Recruiting
        • Alberts Cellular Therapy
        • Contact:
        • Principal Investigator:
          • Andrew McDonald
  • South Korea
      • Daegu, South Korea, 41944
        • Recruiting
        • Kyungpook National University Hospital
        • Contact:
        • Principal Investigator:
          • Joon ho Moon
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
        • Principal Investigator:
          • Je-Hwan Lee
        • Contact:
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • JunShik Hong
        • Contact:
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Jun Ho Jang
        • Contact:
      • Seoul, South Korea, 04401
        • Recruiting
        • Soon Chun Hyang University Hospital Seoul
        • Principal Investigator:
          • Seug Yun Yoon
        • Contact:
      • Seoul, South Korea, 06591
        • Recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • Principal Investigator:
          • Yoo Jin Kim
        • Contact:
  • Spain
    • Castille and León
      • Salamanca, Castille and León, Spain, 37007
        • Recruiting
        • University Clinical Hospital of Salamanca, Department of Hematology
        • Principal Investigator:
          • María Díez Campelo
        • Contact:
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Recruiting
        • University Hospital Vall d'Hebron, Department of Hematology
        • Contact:
        • Principal Investigator:
          • David Valcarcel Ferreiras
    • Girona
      • L'Hospitalet de Llobregat, Girona, Spain, 08908
        • Recruiting
        • Catalan Institute of Oncology, Hospital Duran i Reynals, Department of Clinical Hematology
        • Principal Investigator:
          • Montserrat Arnan Sangerman
        • Contact:
    • Madrid
      • Madrid, Madrid, Spain, 28034
        • Recruiting
        • University Hospital Ramon y Cajal
        • Principal Investigator:
          • Kyra Velazquez Kennedy
        • Contact:
      • Madrid, Madrid, Spain, 28040
        • Recruiting
        • University Hospital Foundation Jimenez Diaz
        • Principal Investigator:
          • Teresa Arquero Portero
        • Contact:
    • Valencia
      • Valencia, Valencia, Spain, 46026
        • Recruiting
        • University and Polytechnic Hospital La Fe
        • Principal Investigator:
          • Elvira Mora Castera
        • Contact:
  • Sweden
      • Lund, Sweden, 221 85
        • Recruiting
        • Skane University Hospital - Lund, Department of Hematology and Vascular Disorders
        • Contact:
        • Principal Investigator:
          • Lars Nilsson
    • Stockholm County
      • Huddinge, Stockholm County, Sweden, 141 57
        • Recruiting
        • Karolinska University Hospital
        • Principal Investigator:
          • Magnus Tobiasson
        • Contact:
    • VG
      • Gothenburg, VG, Sweden, 41345
        • Not yet recruiting
        • Sahlgrenska University Hospital
        • Contact:
        • Principal Investigator:
          • Lena Von Bahr
    • Örebro County
      • Örebro, Örebro County, Sweden, 70185
        • Not yet recruiting
        • A-rebro University Hospital, Hematology Department
        • Contact:
        • Principal Investigator:
          • Bengt Rasmussen
  • Switzerland
      • Bern, Switzerland, 3010
        • Not yet recruiting
        • Insel Gruppe AG, University Clinic for Hematology and Central Hematological Laboratory
        • Contact:
        • Principal Investigator:
          • Natalia Baran
      • Zurich, Switzerland, 8091
        • Not yet recruiting
        • Universitatsspital Zurich, Klinik fur Medizinische Onkologie und Hamatologie
        • Contact:
        • Principal Investigator:
          • Stefan Balabanov
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Switzerland, 4031
        • Not yet recruiting
        • University Hosptial Basel
        • Contact:
        • Principal Investigator:
          • Gregor Stehle
  • Taiwan
      • Taichung, Taiwan, 407219
        • Recruiting
        • Taichung Veterans General Hospital
        • Principal Investigator:
          • Cheng-Hsien Lin
        • Contact:
      • Tainan, Taiwan, 704302
        • Recruiting
        • National Cheng Kung University Hospital
        • Principal Investigator:
          • Tsai-Yun Chen
        • Contact:
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital
        • Principal Investigator:
          • Wen-Chien Chou
        • Contact:
      • Taoyuan City, Taiwan, 333
        • Recruiting
        • Linkou Chang Gung Memorial Hospital
        • Principal Investigator:
          • Ming-Chung Kuo
        • Contact:
    • Changhua County
      • Changhua, Changhua County, Taiwan, 500209
        • Recruiting
        • Changhua Christian Hospital
        • Principal Investigator:
          • Ruo-Han TSENG
        • Contact:
      • Changhua, Changhua County, Taiwan, 50544
        • Recruiting
        • Chang Bing Show Chwan Memorial Hospital
        • Principal Investigator:
          • Cheng-Shyong Chang
        • Contact:
  • Thailand
      • Bangkok, Thailand, 10330
        • Not yet recruiting
        • King Chulalongkorn Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Noppacharn Uaprasert
      • Bangkok, Thailand, 10400
        • Not yet recruiting
        • Ramathibodi Hospital
        • Contact:
        • Principal Investigator:
          • Piyajaroenkij Thanakrit
      • Bangkok, Thailand, 10400
        • Not yet recruiting
        • Rajavithi Hospital
        • Contact:
        • Principal Investigator:
          • Kunapa Iam-arunthai
      • Bangkok, Thailand, 74210
        • Not yet recruiting
        • Banphaeo General Hospital
        • Principal Investigator:
          • Busakorn Sae-Aeng
        • Contact:
      • Chiang Mai, Thailand, 50200
        • Not yet recruiting
        • Maharaj Nakorn ChiangMai Hospital
        • Contact:
        • Principal Investigator:
          • Thanawat Rattanathammethee
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01370
        • Not yet recruiting
        • Adana City Hospital
        • Contact:
        • Principal Investigator:
          • Elif Suyani
      • Ankara, Turkey (Türkiye), 06170
        • Not yet recruiting
        • Ankara Etlik City Hospital
        • Principal Investigator:
          • Merih Kizil Cakar
        • Contact:
      • Ankara, Turkey (Türkiye), 06600
        • Not yet recruiting
        • Ankara University Medical Faculty Cebeci Hospital
        • Principal Investigator:
          • Selami Toprak
        • Contact:
      • Antalya, Turkey (Türkiye), 07100
        • Not yet recruiting
        • Antalya Education and Training Hospital
        • Principal Investigator:
          • Volkan Karakus
        • Contact:
      • Mersin, Turkey (Türkiye), 33200
        • Not yet recruiting
        • Mersin Medicalpark hospital
        • Principal Investigator:
          • ANIL TOMBAK
        • Contact:
      • Sakarya, Turkey (Türkiye), 54290
        • Not yet recruiting
        • Sakarya University Medical Faculty Hospital
        • Principal Investigator:
          • Cenk Sunu
        • Contact:
      • Samsun, Turkey (Türkiye), 55139
        • Not yet recruiting
        • Ondokuz Mayis University School of Medicine, Department of Hematology
        • Contact:
        • Principal Investigator:
          • Engin Kelkitli
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • Queen Elizabeth Hospital Birmingham
        • Principal Investigator:
          • Vidhya Murthy
        • Contact:
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • Addenbrooke's Hospital
        • Principal Investigator:
          • Duncan Brian
        • Contact:
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • St James'S University Hospital
        • Principal Investigator:
          • Anjum Cargo
        • Contact:
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital
        • Principal Investigator:
          • Austin Kulasekararaj
        • Contact:
      • London, United Kingdom, W1G 6AD
        • Recruiting
        • Sarah Cannon Research Institute (SCRI)
        • Principal Investigator:
          • Jennifer O'Sullivan (Dillon)
        • Contact:
      • London, United Kingdom, NW1 2AF
        • Not yet recruiting
        • University College London Hospital
        • Contact:
        • Principal Investigator:
          • Elspeth Payne
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust
        • Principal Investigator:
          • Daniel Wiseman
        • Contact:
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham City Hospital
        • Principal Investigator:
          • Jennifer Byrne
        • Contact:
      • Oxford, United Kingdom, OX3 7LE
        • Recruiting
        • Churchill Hospital
        • Principal Investigator:
          • Connor Chowdhury
        • Contact:
    • Aberdeen City
      • Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
        • Not yet recruiting
        • Aberdeen Royal Infirmary
        • Principal Investigator:
          • Dominic Culligan
        • Contact:
    • Denbighshire
      • Rhyl, Denbighshire, United Kingdom, LL18 5UJ
    • Leics
      • Leicester, Leics, United Kingdom, LE1 5WW
        • Not yet recruiting
        • University Hospitals of Leicester
        • Principal Investigator:
          • Matthew Lee
        • Contact:
    • Tyne and Wear
      • High Heaton, Tyne and Wear, United Kingdom, NE7 7DN
        • Not yet recruiting
        • The Newcastle Upon Tyne University Hospitals Foundation Trust
        • Contact:
        • Principal Investigator:
          • Michelle Lannon
      • Sunderland, Tyne and Wear, United Kingdom, SR4 7TP
        • Not yet recruiting
        • South Tyneside and Sunderland Foundation Trust
        • Principal Investigator:
          • Scott Marshall
        • Contact:
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City Of Hope
        • Principal Investigator:
          • Andrew Artz
        • Contact:
      • Glendale, California, United States, 91206
        • Recruiting
        • Los Angeles Cancer Network
        • Principal Investigator:
          • Eric Lee
        • Contact:
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Principal Investigator:
          • Amanda Kagan
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Smilow Cancer Hospital at Yale-New Haven
        • Principal Investigator:
          • Amer Zeidan
        • Contact:
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital and Clinics
        • Contact:
        • Principal Investigator:
          • Mikkael Sekeres
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
        • Principal Investigator:
          • Rami Komrokji
    • Illinois
      • Peoria, Illinois, United States, 61645
        • Not yet recruiting
        • ILCC. Illinois Cancer Centers
        • Contact:
        • Principal Investigator:
          • Paul Fishkin
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Norton Cancer Institute
        • Principal Investigator:
          • Don Stevens
        • Contact:
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Recruiting
        • Maryland Oncology Hematolofy
        • Principal Investigator:
          • Mohit Narang
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Not yet recruiting
        • MidAmerica Cancer Care
        • Contact:
        • Principal Investigator:
          • Benjamin Fangman
    • Nevada
      • Henderson, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
        • Principal Investigator:
          • Edwin Kingsley
        • Contact:
    • New York
      • Lake Success, New York, United States, 11042
      • Westbury, New York, United States, 11590
        • Not yet recruiting
        • Clinical Research Alliance NY
        • Principal Investigator:
          • Jonathan Goldberg
        • Contact:
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27013
        • Not yet recruiting
        • Novant Health-Cancer Institute
        • Principal Investigator:
          • James Dugan
        • Contact:
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Gabrail Cancer Center Research
        • Contact:
        • Principal Investigator:
          • Nashat Gabrail
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic - Cleveland
        • Contact:
        • Principal Investigator:
          • Akriti Jain
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Recruiting
        • Tennessee Cancer Specialists
        • Contact:
        • Principal Investigator:
          • Tracy Dobbs
      • Memphis, Tennessee, United States, 38120
        • Not yet recruiting
        • Baptist Clinical Research Institute
        • Principal Investigator:
          • Muhammad Raza
        • Contact:
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Ashwin Kishtagari
        • Contact:
    • Texas
      • Denison, Texas, United States, 75020
        • Not yet recruiting
        • Texas Oncology Northeast Texas
        • Principal Investigator:
          • Amir Faridi
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • U.T. MD Anderson Cancer Center, Division of Cancer Medicine
        • Principal Investigator:
          • Guillermo Garcia-Manero
        • Contact:
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • Texas Oncology Gulf Coast
        • Principal Investigator:
          • Andrew Jackson
        • Contact:
      • Webster, Texas, United States, 77598-4085
        • Recruiting
        • Tranquil Research
        • Principal Investigator:
          • John Knecht
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 aspirate, 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.

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

    a. Low-transfusion burden (LTB), defined as 4 to 7 red blood cells (RBC) units per 16 weeks; or b. High-transfusion burden (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) ≥40,000 international units per week (IU/week) for ≥8 doses or equivalent; or ii. Darbepoetin alpha ≥500 micrograms (μg) every 3 weeks for ≥4 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% blasts in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader.
  • 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 or therapy-related (secondary) 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 ≥ 5 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).
  • 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.
  • History of or known active chronic infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). 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 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 corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone lesser than or equal to (≤) 10 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 ≥450 × 10^9/L or ≤25 × 10^9/L.
  • Absolute neutrophil count ≤ 500/µL.
  • Serum aspartate aminotransferase or alanine aminotransferase ≥3 × the upper limit of normal (ULN).
  • Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome.
  • 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 contract research organization (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]).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Elritercept
Elritercept (TAK-226, KER-050) administered subcutaneously every 4 weeks.
Other Names:
  • KER-050
  • TAK-226
Placebo Comparator: 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.
Drug: Placebo
Elritercept (TAK-226, KER-050) matching-placebo administered subcutaneously every 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Transfusion Independence (TI) for ≥8 Weeks
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving TI for ≥24 Weeks
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Collaborators

PSI CRO

Investigators

  • Study Director: Study Director, Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2032

Study Registration Dates

First Submitted

July 5, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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