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

June 12, 2026 updated by: Takeda

A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions

The main aim of this study is to assess how elritercept works in lowering the need for RBC (red blood cell) transfusions and how safe elritercept is when compared with epoetin alfa. Other aims are to learn if elritercept improves tiredness as reported by participants without needing RBC transfusion compared with epoetin alfa, the RBC transfusion burden and quality of life compared with epoetin alfa. The study also aims to find out the extent of the immune response to elritercept. The study will also check on the medical problems (safety) of elritercept.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

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

  • Argentina
      • Buenos Aires, Argentina, 1425
        • Not yet recruiting
        • Swiss Medical Center - Barrio Parque
        • Contact:
        • Principal Investigator:
          • Claudio Marcelo Iastrebner
      • Córdoba, Argentina, 5000
        • Not yet recruiting
        • Sanatorio Allende S.A. - Nueva Cordoba
        • Contact:
        • Principal Investigator:
          • Gustavo D Jarchum
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5000
        • Not yet recruiting
        • Hospital Privado de Cordoba
        • Contact:
        • Principal Investigator:
          • Ana Basquiera
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Not yet recruiting
        • Instituto Medico de la Fundacion Estudios Clinicos
        • Contact:
        • Principal Investigator:
          • Gustavo Jorge Braidot
  • Australia
    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • Not yet recruiting
        • Mid North Coast Local Health District - Mid North Coast Cancer Institute (MNCCI) - Coffs Harbour
        • Principal Investigator:
          • Kyle Crassini
        • Contact:
      • Sydney, New South Wales, Australia, 2217
        • Not yet recruiting
        • South Eastern Sydney Local Health District
        • Contact:
        • Principal Investigator:
          • Sundreswran Ramanathan
      • Waratah, New South Wales, Australia, 2282
        • Not yet recruiting
        • Calvary Mater Newcastle
        • Contact:
        • Principal Investigator:
          • Anoop Enjeti
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Not yet recruiting
        • Royal Adelaide Hospital
        • Principal Investigator:
          • Devendra Hiwase
        • Contact:
      • Bedford Park, South Australia, Australia, 5042
        • Not yet recruiting
        • Flinders Medical Centre
        • Contact:
        • Principal Investigator:
          • Ashanka Beliasgwatte
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Not yet recruiting
        • Monash University-Monash Medical Centre (MMC) - Clayton
        • Principal Investigator:
          • Jake Shortt
        • Contact:
      • Fitzroy, Victoria, Australia, 3065
        • Not yet recruiting
        • St. Vincent's Hospital Melbourne
        • Principal Investigator:
          • Shuhying Tan
        • Contact:
      • Heidelberg, Victoria, Australia, 3084
        • Not yet recruiting
        • Eastern Haematology & Oncology Group or Austin Hospital
        • Principal Investigator:
          • Chun Yew Fong
        • Contact:
      • Richmond, Victoria, Australia, 3004
        • Not yet recruiting
        • Alfred Hospital
        • Contact:
        • Principal Investigator:
          • Shaun Fleming
    • Western Australia
      • Perth, Western Australia, Australia, 6150
        • Not yet recruiting
        • Fiona Stanley Hospital
        • Contact:
        • Principal Investigator:
          • Jasmine Singh
  • Belgium
    • Namur
      • Yvoir, Namur, Belgium, 5530
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Not yet recruiting
        • UZ Leuven
        • Principal Investigator:
          • Marielle Beckers
        • Contact:
    • West Flanders
      • Roeselare, West Flanders, Belgium, 8800
        • Not yet recruiting
        • AZ Delta (H.-Hartziekenhuis Roeselare-Menen vzw (HHRM)) - Campus Rumbeke
        • Principal Investigator:
          • Dries Deeren
        • Contact:
  • Brazil
      • São Paulo, Brazil, 01321-001
        • Not yet recruiting
        • Portuguese Charity of Sao Paulo, Clinical Hematology / Oncology Center
        • Principal Investigator:
          • Phillip Scheinberg
        • Contact:
      • São Paulo, Brazil, 01409-000
        • Not yet recruiting
        • Hospital 9 de Julho (Rede Americas/DASA)
        • Contact:
        • Principal Investigator:
          • Vinicius Molla
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41253-190
        • Not yet recruiting
        • D'OR Institute for Research and Education
        • Contact:
        • Principal Investigator:
          • Laine Santos Fiscina Alvarenga
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035903
        • Not yet recruiting
        • Porto Alegre Clinical Hospital (HCPA)
        • Principal Investigator:
          • Laura Maria Fogliatto
        • Contact:
      • Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
        • Not yet 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
        • Centro de Hematologia e Oncologia (CHO)
        • Contact:
        • Principal Investigator:
          • Ana Claudia Dall'Oglio
    • São Paulo
      • Jaú, São Paulo, Brazil, 17210080
        • Not yet recruiting
        • Hospital Amaral Carvalho (HAC)
        • Contact:
        • Principal Investigator:
          • Ederson Mattos
      • Santos, São Paulo, Brazil, 11075-101
        • Not yet recruiting
        • Irmandade da Santa Casa da Misericordia de Santos (ISCMS)
        • Principal Investigator:
          • Elaine Mancilha
        • Contact:
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Recruiting
        • Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD)
        • Principal Investigator:
          • Pencho Georgiev
        • Contact:
      • Sofia, Bulgaria, 1756
        • Not yet recruiting
        • Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology
        • Principal Investigator:
          • Tanya Yankova
        • Contact:
  • France
      • Nice, France, 06200
        • Not yet recruiting
        • Centre Hospitalier Universitaire (CHU) de Nice - Hopital L'Archet I - Hematologie Clinique
        • Principal Investigator:
          • Thomas Cluzeau
        • Contact:
      • Paris, France, 75010
        • Not yet recruiting
        • Saint-Louis Hospital
        • Principal Investigator:
          • Lionel Ades
        • Contact:
    • Isere
      • La Tronche, Isere, France, 38700
        • Not yet recruiting
        • Centre Hospitalier Universitaire Grenoble Alpes
        • Principal Investigator:
          • Mathieu Meunier
        • Contact:
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Not yet recruiting
        • Poitiers University Hospital Center - Miletrie Site
        • Principal Investigator:
          • Jose Miguel Torregrosa-Diaz
        • Contact:
    • X
      • Villejuif, X, France, 94805
  • Germany
      • Berlin, Germany, 12200
        • Not yet recruiting
        • Charite Campus Benjamin Franklin
        • Principal Investigator:
          • Kathrin Rieger
        • Contact:
      • Berlin, Germany, 10715
    • Bavaria
      • Bayreuth, Bavaria, Germany, 95445
        • Not yet recruiting
        • Universitatsklinikum Bayreuth, Med. Klinik IV
        • Principal Investigator:
          • Alexander Kiani
        • Contact:
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48153
        • Not yet recruiting
        • Gemeinschaftspraxis fuer Haematologie und Onkologie - Praxis Steinfurter Strasse
        • Principal Investigator:
          • Ruediger Liersch
        • Contact:
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06120
        • Not yet recruiting
        • University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
        • Principal Investigator:
          • Haifa Al-Ali
        • Contact:
  • Greece
      • Ioannina, Greece, 45500
        • Not yet recruiting
        • Faculty of Medicine, School of Health Sciences, University of Ioannina
        • Principal Investigator:
          • Eleftheria Hatzimichael
        • Contact:
    • Central Athens
      • Athens, Central Athens, Greece, 11526
        • Not yet recruiting
        • Laiko General Hospital
        • Principal Investigator:
          • Theodoros Vassilakopoulos
        • Contact:
      • Athens, Central Athens, Greece, 11527
        • Not yet recruiting
        • National and Kapodistrian University of Athens (NKUA)-Laiko General Hospital
        • Contact:
        • Principal Investigator:
          • Panagiotis Diamantopoulos
    • Evros
      • Alexandroupoli, Evros, Greece, 68100
        • Not yet recruiting
        • Democritus University of Thrace (DUTH) - University General Hospital of Alexandroupolis
        • Contact:
        • Principal Investigator:
          • Ioannis Kotsianidis
    • Macedonia
      • Thessaloniki, Macedonia, Greece, 55133
        • Not yet recruiting
        • General Hospital of Thessaloniki "Ippokratio"
        • Contact:
        • Principal Investigator:
          • Eleni Gavriilaki
    • West Athens
      • Athens, West Athens, Greece, 12462
        • Not yet recruiting
        • National and Kapodistrian University of Athens-University General Hospital Attikon
        • Principal Investigator:
          • Vassiliki Pappa
        • Contact:
  • Hungary
    • H-B
      • Debrecen, H-B, Hungary, 500096
        • Not yet recruiting
        • University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology
        • Principal Investigator:
          • Arpad Illes
        • Contact:
    • Komárom-Esztergom
      • Tatabánya, Komárom-Esztergom, Hungary, 2800
        • Not yet recruiting
        • Szent Borbala Korhaz, Department of Internal Medicine and Haematology, Division of Hematology
        • Contact:
        • Principal Investigator:
          • Zsofia Simon
  • India
      • Chandigarh, India, 160012
        • Not yet recruiting
        • Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
        • Principal Investigator:
          • Pankaj Malhotra
        • Contact:
      • Delhi, India, 110017
        • Not yet recruiting
        • Max SuperSpeciality Saket, Delhi
        • Contact:
        • Principal Investigator:
          • Rayaz Ahmed
    • Kerala
      • Kochi, Kerala, India, 682041
        • Not yet recruiting
        • AIMS, Kochi
        • Contact:
        • Principal Investigator:
          • Neeraj Sidharthan
    • Maharashtra
      • Pune, Maharashtra, India, 411004
        • Not yet recruiting
        • Sahyadri Hospitals, Pune
        • Contact:
        • Principal Investigator:
          • Shashikant Apte
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632517
        • Not yet recruiting
        • Christian Medical College
        • Principal Investigator:
          • Biju George
        • Contact:
    • Telangana
      • Hyderabad, Telangana, India, 500096
        • Not yet recruiting
        • Apollo Hospital Hyderabad
        • Contact:
        • Principal Investigator:
          • Padmaja Lokireddy
    • West Bengal
      • Kolkata, West Bengal, India, 682041
        • Not yet recruiting
        • Tata Medical Center
        • Principal Investigator:
          • Arijit Nag
        • Contact:
  • Ireland
      • Cork, Ireland, T12 DC4A
        • Not yet recruiting
        • Cork University Hospital
        • Principal Investigator:
          • Vitaliy Mykytiv
        • Contact:
      • Dublin, Ireland, Dublin 7
        • Not yet recruiting
        • Mater Misericordiae University Hospital
        • Principal Investigator:
          • Su Maung
        • Contact:
      • Dublin, Ireland
        • Not yet recruiting
        • St. James's Hospital
        • Contact:
        • Principal Investigator:
          • Catherine Flynn
      • Galway, Ireland
        • Not yet recruiting
        • University Hospital Galway
        • Principal Investigator:
          • Janusz Krawczyk
        • Contact:
  • Italy
      • Bologna, Italy, 40138
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Lorenzo e Ariosto Seragnoli"
        • Contact:
        • Principal Investigator:
          • Stefania Paolini
      • Milan, Italy, 20132
        • Not yet recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:
        • Principal Investigator:
          • Elisa Diral
      • Naples, Italy, 80131
        • Not yet recruiting
        • Ospedale Cardarelli
        • Principal Investigator:
          • Mario Annunziata
        • Contact:
      • Novara, Italy, 28100
        • Not yet recruiting
        • Ospedale di Novara
        • Principal Investigator:
          • Andrea Patriarca
        • Contact:
      • Padua, Italy, 35128
        • Not yet recruiting
        • Universita degli Studi di Padova-Azienda Ospedaliera di Padova
        • Contact:
        • Principal Investigator:
          • Gianni Binotto
      • Rome, Italy, 00133
        • Not yet recruiting
        • Universita Degli Studi di Roma "Tor Vergata"
        • Principal Investigator:
          • Maria Teresa Voso
        • Contact:
    • Florence
      • Florence, Florence, Italy, 50141
        • Not yet recruiting
        • Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)
        • Principal Investigator:
          • Valeria Santini
        • Contact:
    • Milan
      • Rozzano, Milan, Italy, 20089
        • Not yet recruiting
        • Gruppo Humanitas-Humanitas Research Hospital (Istituto Clinico Humanitas)
        • Contact:
        • Principal Investigator:
          • Matteo Giovanni Della Porta
    • PV
      • Pavia, PV, Italy, 27100
        • Not yet recruiting
        • Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology
        • Principal Investigator:
          • Luca Malcovati
        • Contact:
    • Rome
      • Roma, Rome, Italy, 00161
        • Not yet recruiting
        • Policlinico Umberto I
        • Contact:
        • Principal Investigator:
          • Massima Breccia
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Recruiting
        • Institute of Cancer Research and Treatment of Candiolo
        • Principal Investigator:
          • Elena Crisa
        • Contact:
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 460-0001
        • Recruiting
        • NHO Nagoya Medical Center
        • Principal Investigator:
          • Hiroatsu Iida
        • Contact:
    • Fukushima, Japan
      • Fukushima, Fukushima, Japan, Japan, 960-1295
        • Recruiting
        • Fukushima Medical University Hospital
        • Principal Investigator:
          • Takayuki Ikezoe
        • Contact:
          • Site Contact
          • Phone Number: +81-24-547-1111
    • Gifu
      • Gifu, Gifu, Japan, 500-8323
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japan, 720-0001
        • Recruiting
        • Chugoku Central Hospital
        • Principal Investigator:
          • Masanori Makita
        • Contact:
    • Hyōgo
      • Amagasaki-shi, Hyōgo, Japan, 660-8550
        • Not yet recruiting
        • Hyogo Prefectural Amagasaki General Medical Center
        • Principal Investigator:
          • Mitsumasa Watanabe
        • Contact:
    • Tochigi
      • Mibu, Tochigi, Japan, 321-0293
        • Recruiting
        • Dokkyo Medical University Hospital
        • Principal Investigator:
          • Yoichi Imai
        • Contact:
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8677
        • Not yet recruiting
        • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
        • Principal Investigator:
          • Tomomi Tobai
        • Contact:
      • Shinagawa-ku, Tokyo, Japan, 141-8625
        • Recruiting
        • Ntt Medical Center Tokyo
        • Principal Investigator:
          • Motoshi Ichikawa
        • Contact:
  • Lithuania
      • Vilnius, Lithuania, 08661
        • Not yet recruiting
        • Vilniaus Universiteto Ligonine Santaros Klinikos (VULSK) (Vilniaus Universiteto Ligonines Santariskiu Klinikos)
        • Principal Investigator:
          • Andrius Degulys
        • Contact:
    • LT
      • Kaunas, LT, Lithuania, 50161
        • Not yet recruiting
        • Hospital of Lithuania University of Health Sciences Kaunas, Clinic of Oncology and Hematology
        • Principal Investigator:
          • Milda Rudzianskiene
        • Contact:
  • Malaysia
    • Johor
      • Johor Bahru, Johor, Malaysia, 80100
        • Not yet recruiting
        • Hospital Sultanah Aminah Johor Bahru (HSAJB)
        • Contact:
        • Principal Investigator:
          • Wong Yih Seong
    • Kedah
      • Alor Star, Kedah, Malaysia, 11450
        • Not yet recruiting
        • Hospital Sultanah Bahiyah (HSB) (Klinik Kesihatan Bandar Alor Setar/Hospital Alor Setar)
        • Contact:
        • Principal Investigator:
          • Liew Hong Keng
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 59200
        • Not yet recruiting
        • Universiti Malaya - Faculty of Medicine (FOM)
        • Contact:
        • Principal Investigator:
          • Bee Ping Chong
  • Mexico
      • Mexico City, Mexico, 14080
        • Not yet recruiting
        • National Institute of Medical Sciences and Nutrition Salvado
        • Contact:
        • Principal Investigator:
          • Elia Apodaca
      • Oaxaca City, Mexico, 68000
        • Not yet recruiting
        • Oaxaca Site Management Organization S.C. - Oaxaca
        • Contact:
        • Principal Investigator:
          • Eva Fabiola Ramirez Romero
    • Michoacán
      • Morelia, Michoacán, Mexico, 58260
        • Not yet recruiting
        • Centro de Investigacion Clinica Chapultepec (CICC), S.A. de C.V
        • Contact:
        • Principal Investigator:
          • Gregorio Campos Cabrera
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Not yet recruiting
        • Universidad Autonoma de Nuevo Leon-Hospital Universitario "Dr. Jose Eleuterio Gonzalez" - Servicio de Hematologia
        • Principal Investigator:
          • David Gomez Almaguer
        • Contact:
  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1081HV
        • Not yet recruiting
        • Amsterdam UMC-Locatie VUMC (Vrije Universiteit Medisch Centrum)
        • Contact:
        • Principal Investigator:
          • Arjan A. van de Loosdrecht
  • Norway
      • Oslo, Norway, 0372
        • Not yet recruiting
        • Oslo Universitetssykehus HF
        • Contact:
        • Principal Investigator:
          • Synne Torkildsen
    • Vest
      • Bergen, Vest, Norway, 5021
        • Not yet recruiting
        • Helse Bergen HF
        • Contact:
        • Principal Investigator:
          • Astrid Olsnes
    • Vestfold
      • Tønsberg, Vestfold, Norway, 3116
        • Not yet recruiting
        • Sykehuset Vestfold HF
        • Contact:
        • Principal Investigator:
          • Emil Nyquist
  • Poland
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-019
        • Not yet recruiting
        • Pratia Wroclaw
        • Contact:
        • Principal Investigator:
          • Elzbieta Kalicinska
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-172
        • Not yet recruiting
        • Warszawski Uniwersytet Medyczny (WUM) (Medical University of Warsaw)
        • Principal Investigator:
          • Krzysztof Madry
        • Contact:
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-519
        • Not yet recruiting
        • Pratia Onkologia Katowice
        • Principal Investigator:
          • Sebastian Grosicki
        • Contact:
    • Wielkopolska
      • Skorzewo, Wielkopolska, Poland, 60185
        • Recruiting
        • Aidport
        • Contact:
        • Principal Investigator:
          • Michael Kwiatek
    • maAopolska
      • Krakow, maAopolska, Poland, 50-727
        • Not yet recruiting
        • Pratia MCM Krakow
        • Principal Investigator:
          • Wojciech Jurczak
        • Contact:
  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400124
        • Not yet recruiting
        • Institutul Oncologic Prof. Dr. I. Chiricu
        • Principal Investigator:
          • Ciprian Tomuleasa
        • Contact:
    • Dolj
      • Craiova, Dolj, Romania, 20014
        • Not yet recruiting
        • Filantropia Municipal Clinical Hospital
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Luminita Ocroteala
  • South Korea
      • 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, 06591
        • Recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Yoo-Jin Kim
      • Seoul, South Korea, 02841
        • Not yet recruiting
        • Korea University Anam Hospital
        • Principal Investigator:
          • Yong Park
        • Contact:
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Not yet recruiting
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Soo-Mee Bang
        • Contact:
    • Yongsan-gu
      • Seoul, Yongsan-gu, South Korea, 04401
        • Recruiting
        • Soon Chun Hyang University Hospital Seoul
        • Principal Investigator:
          • Seug Yun Yoon
        • Contact:
  • Spain
      • Barcelona, Spain, 8035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron-Institut de Recerca (VHIR)
        • Principal Investigator:
          • David Valcarcel Ferreiras
        • Contact:
      • Madrid, Spain, 28034
        • Not yet recruiting
        • University Hospital Ramon y Cajal
        • Principal Investigator:
          • Kyra Velazquez Kennedy
        • Contact:
      • Málaga, Spain, 29010
        • Not yet recruiting
        • Hospital Universitario Virgen de la Victoria (HUVV)
        • Contact:
        • Principal Investigator:
          • Regina Garcia-Delgado
      • Salamanca, Spain, 37007
        • Not yet recruiting
        • Universidad de Salamanca - Hospital Universitario de Salamanca
        • Principal Investigator:
          • Maria Diez Campelo
        • Contact:
      • Valencia, Spain, 46026
        • Not yet recruiting
        • University and Polytechnic Hospital La Fe
        • Principal Investigator:
          • Elvira Mora Castera
        • Contact:
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Not yet recruiting
        • Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals Location
        • Principal Investigator:
          • Montserrat Arnan Sangerman
        • Contact:
    • Seville
      • Seville, Seville, Spain, 41013
        • Not yet recruiting
        • Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
        • Principal Investigator:
          • Jose Francisco Falantes Gonzalez
        • Contact:
  • Switzerland
      • Bern, Switzerland, 3010
        • Not yet recruiting
        • Insel Gruppe AG
        • Contact:
        • Principal Investigator:
          • Natalia Baran
      • Chur, Switzerland
        • Not yet recruiting
        • Kantonsspital Graubünden
        • Contact:
        • Principal Investigator:
          • Tobias Silzle
      • Zurich, Switzerland, 8091
        • Not yet recruiting
        • Universitätsspital Zürich
        • Contact:
        • Principal Investigator:
          • Stefan Balabanov
  • Taiwan
      • Changhua, Taiwan, 505029
        • Recruiting
        • Chang Bing Show Chwan Memorial Hospital
        • Principal Investigator:
          • Cheng-Shyong Chang
        • Contact:
      • Kaohsiung City, Taiwan, 807
        • Not yet recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Principal Investigator:
          • Yi-Chang Liu
        • Contact:
      • Tainan, Taiwan, 704
        • Not yet recruiting
        • National Cheng Kung University Hospital
        • Principal Investigator:
          • Tsai-Yun Chen
        • Contact:
      • Taipei, Taiwan, 112201
        • Not yet recruiting
        • Taipei Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Chia-Jen Liu
      • Taipei, Taiwan, 100225
        • Not yet recruiting
        • National Taiwan University Hospital - East Campus
        • Principal Investigator:
          • Chien-Chin Lin
        • Contact:
    • TW
      • Taichung, TW, Taiwan, 404
        • Not yet recruiting
        • China Medical University Hospital
        • Principal Investigator:
          • Su-Peng Yeh
        • Contact:
  • Thailand
      • Bangkok, Thailand, 10330
        • Not yet recruiting
        • King Chulalongkorn Memorial Hospital
        • Principal Investigator:
          • Noppacharn Uaprasert
        • Contact:
    • Chiang Mai
      • Chiang Mai, Chiang Mai, Thailand, 50200
        • Not yet recruiting
        • Maharaj Nakorn Chiangmai Hospital
        • Principal Investigator:
          • Thanawat Rattanathammethee
        • Contact:
    • Samutsakorn
      • Samut Sakhon, Samutsakorn, Thailand, 74120
        • Not yet recruiting
        • Banphaeo General Hospital
        • Principal Investigator:
          • Busakorn Sae-Aeng
        • Contact:
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34381
        • Not yet recruiting
        • Istanbul Florence Nightingale Hospital
        • Contact:
        • Principal Investigator:
          • Omur Gokmen Sevindik
      • Izmir, Turkey (Türkiye), 35100
        • Not yet recruiting
        • Ege University Medical Faculty
        • Principal Investigator:
          • Guray Saydam
        • Contact:
      • Samsun, Turkey (Türkiye), 55139
        • Not yet recruiting
        • Ondokuz Mayis University School of Medicine, Department of Hematology
        • Principal Investigator:
          • Engin Kelkitli
        • Contact:
    • Ankara, Turkey
      • Ankara, Ankara, Turkey, Turkey (Türkiye), 06520
        • Not yet recruiting
        • Ankara Universitesi, TAp FakAltesi, Hematoloji BD
        • Contact:
        • Principal Investigator:
          • Pervin Topcuoglu
    • Mezitli
      • Mersin, Mezitli, Turkey (Türkiye), 33000
        • Not yet recruiting
        • Mersin Medicalpark hospital
        • Principal Investigator:
          • Anil Tombak
        • Contact:
  • United Kingdom
      • Leeds, United Kingdom
        • Not yet recruiting
        • Leeds Teaching Hospitals NHS Trust
        • Principal Investigator:
          • Matthew Lee
        • Contact:
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital
        • Principal Investigator:
          • Austin Kulasekararaj
        • Contact:
    • Lincolnshire
      • Boston, Lincolnshire, United Kingdom, PE227BU
        • Recruiting
        • Pilgrim Hospital
        • Principal Investigator:
          • Ciro Rinaldi
        • Contact:
    • OXON
      • Oxford, OXON, United Kingdom, OX3 7LE
        • Not yet recruiting
        • Churchill Hospital
        • Contact:
        • Principal Investigator:
          • Oni Chowdhury
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • Not yet recruiting
        • Queen Elizabeth Hospital Birmingham
        • Principal Investigator:
          • Vidhya Murthy
        • Contact:
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Not yet recruiting
        • Banner MD Anderson Cancer Center
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Mark Faber
    • California
      • Duarte, California, United States, 91010
        • Not yet recruiting
        • City of Hope - Comprehensive Cancer Center (CCC)
        • Principal Investigator:
          • Andrew Artz
        • Contact:
      • Santa Rosa, California, United States, 95403
        • Not yet recruiting
        • Providence Medical Group
        • Principal Investigator:
          • Jarrod Holmes
        • Contact:
      • Whittier, California, United States, 90720
        • Not yet recruiting
        • Cancer & Blood Research Center
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Merrill Shum
    • Florida
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • University of Miami
        • Principal Investigator:
          • Mikkael Sekeres
        • Contact:
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • BRCR Medical Center Inc
        • Contact:
        • Principal Investigator:
          • Chintan Gandhi
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Nikolaos Papadantonakis
        • Contact:
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Recruiting
        • Orchard Healthcare Research Inc. (OHR) - Skokie
        • Principal Investigator:
          • Ira Oliff
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Not yet recruiting
        • Norton Cancer Institute
        • Principal Investigator:
          • Don Stevens
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Recruiting
        • American Oncology Partners P.A. MidAmerica Cancer Care
        • Contact:
        • Principal Investigator:
          • Benjamin Fangman
    • New York
      • The Bronx, New York, United States, 10467
        • Not yet recruiting
        • Albert Einstein College - Montefiore
        • Principal Investigator:
          • Aditi Shastri
        • Contact:
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27106
        • Not yet recruiting
        • Novant Health Care Institute
        • Principal Investigator:
          • James Dugan
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland clinic OH
        • Principal Investigator:
          • Hetty Carraway
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Not yet recruiting
        • Fox Chase Cancer Center
        • Principal Investigator:
          • Iberia Sosa
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology, PLLC
        • Contact:
        • Principal Investigator:
          • Constantine Logothetis
    • Texas
      • Baytown, Texas, United States, 77521
      • Denton, Texas, United States, 76201
        • Not yet recruiting
        • Texas Oncology - Denton
        • Principal Investigator:
          • Charles Kurkul
        • Contact:
          • Site Contact
      • Fort Worth, Texas, United States, 76104
        • Not yet recruiting
        • The Center for Cancer and Blood Disorders
        • Principal Investigator:
          • Ray Page
        • Contact:
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • The University of Texas-MD Anderson Cancer Center - Leukemia Center
        • Principal Investigator:
          • Guillermo Garcia-Manero
        • Contact:
      • Houston, Texas, United States, 77090
        • Not yet recruiting
        • Lumi Research
        • Contact:
          • Site Contact
        • Principal Investigator:
          • David Nguyen
      • The Woodlands, Texas, United States, 77380
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Not yet recruiting
        • Huntsman Cancer Institute
        • Contact:
        • Principal Investigator:
          • Zaker Schwabkey
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Not yet recruiting
        • Virginia Commonwealth University (VCU)-Medical Center - North Hospital
        • Contact:
        • Principal Investigator:
          • Ruchi Desai
    • West Virginia
      • Wheeling, West Virginia, United States, 26003
        • Not yet recruiting
        • West Virginia University Cancer Institute
        • Principal Investigator:
          • Bhavana (Tina) Bhatnagar
        • 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

  1. Male or female participants aged ≥ 18 years or older at time of signing the informed consent form (ICF).
  2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF prior to any trial-related procedures being conducted and authorization to use protected health information and personal data in accordance to national and local privacy regulations.
  3. Documented diagnosis of myelodysplastic syndrome(s) (MDS) according to WHO 2016 classification that meets International Prognostic Scoring System - Revised (IPSS-R) classification of very low-, low-, or intermediate-risk disease, confirmed by central laboratory independent reviewer prior to randomization. Hemoglobin (Hgb), platelet, and absolute neutrophil count (ANC) values should be collected greater than (>) 14 days after red blood cell (RBC) transfusion or greater than (>) 7 days after platelet transfusion, unless otherwise considered to be pretransfusion values.
  4. Bone marrow less than (<) 5% blasts in an evaluable bone marrow collected at screening and confirmed by central pathology independent reviewer.
  5. Endogenous serum erythropoietin s (EPO) level of <500 U/L. Should be results from blood samples collected >14 days following an RBC transfusion to evaluate for eligibility unless considered pretransfusion values.

  6. Participant requires RBC transfusion, as documented by the following criteria. A transfusion requirement of 2 to 6 pRBCs units/8 weeks confirmed for a minimum of 8 weeks immediately preceding randomization.

    • Hgb levels at the time of or within 3 days prior to administration of a RBC transfusion must have been less than or equal to (≤) 9.0 grams per deciliter (g/dL) (5.6 millimoles per liter (mmol/L)) with symptoms of anemia (or ≤7 g/dL [4.3 mmol/L] in the absence of symptoms) in order for the transfusion to be counted towards meeting eligibility criteria.

    • RBC transfusions administered when hemoglobin (Hgb) levels were >9.0 g/dL (or >7 g/dL in the absence of symptoms) and/or RBC transfusions administered for elective surgery, infections or bleeding events will not qualify as a required transfusion for the purpose of meeting eligibility criteria or stratification.

  7. Hgb <11.0 g/dL (6.8 mmol/L) after last RBC transfusion preceding randomization. Local laboratory is acceptable to facilitate randomization.
  8. Eastern Cooperative Oncology Group score of 0, 1, or 2. Exclusion Criteria

  1. Prior therapy with any of the following:

    1. Epoetin alfa

      • At the investigator's discretion in consultation with the medical monitor, may be allowed if received no more than 2 doses of only epoetin alfa ≥8 weeks prior to randomization. No other erythropoiesis-stimulating agent (ESA) agent is allowed.

    2. Darbepoetin
    3. Granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor administered ≤8 weeks (56 days) prior to randomization unless given for treatment of febrile neutropenia.

    4. Immunomodulatory drug (IMiDs) including lenalidomide

      • At the investigator's discretion in consultation with the medical monitor may be allowed if received ≤1 week of an IMiD ≥8 weeks prior to randomization.

    5. Hypomethylating agent

      • At the investigator's discretion, in consultation with the medical monitor may be allowed if received no more than 2 doses ≥8 weeks prior to randomization.

    6. Luspatercept, sotatercept, imetelstat, or elritercept
    7. Immunosuppressive therapy
    8. Hematopoeitic cell transplant
    9. Iron chelation if administered ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed Vitamin B12 or folate therapy initiated within 4 weeks prior to randomization. Participants on stable replacement doses for ≥4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.
    10. Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed
    11. High-dose corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone ≤10 mg/day or corticosteroid equivalent for ≥ 4 weeks are allowed. Other disease modifying treatments for autoimmune diseases may be allowed upon medical monitor review.
    12. Investigational agent or any other agent intended for treatment MDS treatment
  2. Diagnosed to have MDS associated with del(5q) cytogenetic abnormality or MDS unclassifiable according to WHO 2016 classification or secondary MDS.
  3. Known history of diagnosis of acute myeloid leukemia (AML).
  4. Anemia due to any other known cause including but not limited to thalassemia; hypothyroidism; due to iron, vitamin B12, vitamin B6, zinc, or folate deficiencies; autoimmune or hereditary hemolytic anemia; any type of known clinically significant bleeding or sequestration or drug induced anemia, hemolytic anemia, or bleeding events.

  5. 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. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening
  6. Known ejection fraction <35%, confirmed by a local echocardiogram performed during screening, or a previously performed echocardiogram if collected within 6 months before screening.
  7. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (DVT; including proximal and distal), pulmonary or arterial embolism, arterial thrombosis or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.
  8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimeters of mercury (mmHg) and/or diastolic blood pressure ≥100 mmHg despite adequate treatment.

  9. Prior history of malignancies, other than MDS. Participants who are free of other malignant disease for ≥3 years and have completed treatment, including maintenance are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:

    1. Basal or squamous cell carcinoma of the skin;
    2. Carcinoma in situ of the cervix;
    3. Carcinoma in situ of the breast;
    4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis [TNM] clinical staging system).
  10. History of solid organ or bone marrow transplantation.
  11. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 14 days before randomization.
  12. Known positive for human immunodeficiency virus (HIV), active infectious hepatitis B virus (HBV), or active infectious 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.
  13. Body mass index ≥ 40 kilograms per square meter (kg/m^2).
  14. Major surgery within 28 days before randomization.
  15. New-onset seizures or poorly controlled seizures within 12 weeks prior to randomization are excluded from trial participation.
  16. History of allergy/anaphylaxis to investigational product (including epoetin alfa) excipients (refer to the current elritercept investigator's brochure for a list of excipients) or recombination proteins.
  17. History of pure red cell aplasia and/or antibody against erythropoietin (EPO).

  18. Any of the following laboratory abnormalities:

    1. ANC <500/microliter (μL) (0.5×109/L).
    2. Platelet count <50,000/μL (50×109/L) or ≥450,000/μL (450×109/L).
    3. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3× upper limit of the normal (ULN).
    4. Total bilirubin ≥2×ULN. 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.
    5. Estimated glomerular filtration rate <30 mL/min/1.73 m^2 as determined by the Chronic Kidney Disease Epidemiology (CKD-EPI) collaboration equation.
    6. Ferritin ≤50 micrograms per liter (μg/L).
    7. Folate ≤2.0 nanograms per milliliter (ng/mL).
    8. Vitamin B12 ≤200 picograms per milliliter (pg/mL).
  19. Ongoing participation in another interventional clinical trial.
  20. Participant is unwilling or in the opinion of the investigator the participant is unable to comply with the requirements of the protocol.
  21. Is a participant of childbearing potential (POCBP) but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of trial intervention.
  22. Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom during the entire trial intervention period until at least 60 days after the last dose of trial intervention.
  23. If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire trial intervention period until at least 60 days after the last dose of trial intervention.
  24. For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elritercept
Participants will receive a starting dose of elritercept at 3.75 milligrams per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks, and may have the dose escalated to 5.0 mg/kg if needed,
Drug: Elritercept
Elritercept, SC, injection.
Other Names:
  • TAK-226
Active Comparator: Epoetin Alfa
Participants will receive a starting dose of epoetin Alfa at 450 international units per kilograms (IU/kg) administered SC once every week, and may have the dose escalated up to 1050 IU/kg.
Drug: Epoetin Alfa
Epoetin Alfa SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants who are RBC Transfusion Independent (RBC-TI) for any Consecutive Greater Than Equal to (≥) 12-Week Period From Day 1 Through 24 Weeks With Concurrent Mean Hemoglobin (Hgb) Increase ≥ 1.5 Grams per Deciliter (g/dL) From Baseline
Time Frame: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
RBC-TI is defined as no red blood cell (RBC) transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants who are RBC-TI for any Consecutive ≥16-Week Period From Day 1 to 24 Weeks
Time Frame: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants who are RBC-TI for any Consecutive ≥12-Week Period From Day 1 to 24 Weeks
Time Frame: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants who are RBC-TI for a Consecutive 24-Week Period From Day 1
Time Frame: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants who Have Confirmed Meaningful Improvement or no Meaningful Deterioration in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score With no RBC Transfusions Between Week 12 to Week 24
Time Frame: From End of Week 12 to End of Week 24
The FACT-An questionnaire is used to assess the effects of disease symptoms on functioning and well-being in participants with anemia. The FACT-An Anemia scale includes 13 fatigue-specific items (which together comprise the FACIT-Fatigue scale).
From End of Week 12 to End of Week 24
Proportion of Participants who Achieved Hematological Improvement-Erythroid (HI-E) for a Minimum 8-Week Period From Day 1 to 24 Weeks
Time Frame: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
HI-E is defined as percentage of participants meeting HI-E criteria sustained over any consecutive 56-day period over the first 24 weeks.
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants who Achieved Hematological Improvement-Erythroid (HI-E) for a Minimum 12-Week Period From Day 1 to 48 Weeks
Time Frame: From Cycle 1 Day 1 through Week 48 (each cycle is 28 days)
HI-E is defined as percentage of participants meeting HI-E criteria sustained over any consecutive 84-day period over the 48 weeks.
From Cycle 1 Day 1 through Week 48 (each cycle is 28 days)
Proportion of Participants who are RBC-TI for a Minimum Consecutive 8-Week Period From Day 1 to 24 Weeks
Time Frame: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants who are RBC-TI for a Minimum Consecutive 24-Week Period From Day 1 to 48 Weeks
Time Frame: From Cycle 1 Day 1 through Week 48 (each cycle is 28 days)
From Cycle 1 Day 1 through Week 48 (each cycle is 28 days)
Time From Date of First Dose to First Onset of Achieving RBC-TI
Time Frame: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
RBC-TI is defined as the absence of RBC transfusions for a prespecified period of time during continued treatment. Time from date of first dose to first onset of achieving RBC-TI for minimum consecutive 12 weeks and for minimum consecutive 16 weeks.
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Mean Hgb Change From Baseline Through 24 Weeks and 48 Weeks
Time Frame: From Baseline through Week 24 and Week 48
From Baseline through Week 24 and Week 48
Maximum Duration of RBC-TI for Participants who Achieved RBC-TI for a Consecutive ≥12 Weeks and ≥16 Weeks
Time Frame: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Total Number of Packed Red Blood Cells (pRBC) Units Received During the Study Treatment
Time Frame: From Cycle 1 Day 1 to End of Treatment (approximately 5 years) (each cycle is 28 days)
From Cycle 1 Day 1 to End of Treatment (approximately 5 years) (each cycle is 28 days)
Monthly Average of pRBC Units Received During Study Treatment Period
Time Frame: From Cycle 1 Day 1 to End of Treatment (approximately 5 years) (each cycle is 28 days)
From Cycle 1 Day 1 to End of Treatment (approximately 5 years) (each cycle is 28 days)
Time From Date of First Dose of Study Drug to Date of First RBC Transfusion Received During Treatment Period
Time Frame: From Cycle 1 Day 1 to End of Treatment (approximately 5 years) (each cycle is 28 days)
From Cycle 1 Day 1 to End of Treatment (approximately 5 years) (each cycle is 28 days)
Time From Date of First Dose of Study Drug to First Onset of Achieving HI-E for Minimum Consecutive 8 Weeks Period
Time Frame: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants with Meaningful Improvement in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Scores
Time Frame: From Cycle 1 Day 1 through Week 24 and 48 (each cycle is 28 days)
EORTC QLQ-C30 is a 30-item,participant-reported multidomain questionnaire designed to assess the functioning,well-being,and symptom experience of patients with cancer.
From Cycle 1 Day 1 through Week 24 and 48 (each cycle is 28 days)
Proportion of Participants with Meaningful Improvement in FACT-Anemia (FACT-An) Scale Scores
Time Frame: From Cycle 1 Day 1 through Week 24 and 48 (each cycle is 28 days)
The FACT-An questionnaire is used to assess the effects of disease symptoms on functioning and well-being in participants with anemia.
From Cycle 1 Day 1 through Week 24 and 48 (each cycle is 28 days)
Proportion of Participants with Meaningful Improvement in FACIT-Fatigue Scale Scores
Time Frame: From Cycle 1 Day 1 through Week 24 and 48 (each cycle is 28 days)
The FACT-An Anemia scale includes 13 fatigue-specific items (which together comprise the FACIT-Fatigue scale).
From Cycle 1 Day 1 through Week 24 and 48 (each cycle is 28 days)
Time to Confirmed Improvement and Time to Confirmed Deterioration in EORTC QLQ-C30 Scale Scores
Time Frame: Baseline through Week 24 and 48
EORTC QLQ-C30 is a 30-item,participant-reported multidomain questionnaire designed to assess the functioning,well-being,and symptom experience of patients with cancer.
Baseline through Week 24 and 48
Time to Confirmed Improvement and Time to Confirmed Deterioration in FACT-An Scale Scores
Time Frame: Baseline through Week 24 and 48
The FACT-An questionnaire is used to assess the effects of disease symptoms on functioning and well-being in participants with anemia.
Baseline through Week 24 and 48
Time to Confirmed Improvement and Time to Confirmed Deterioration in FACIT-Fatigue Scale Scores
Time Frame: Baseline through Week 24 and 48
The FACT-An Anemia scale includes 13 fatigue-specific items (which together comprise the FACIT-Fatigue scale).
Baseline through Week 24 and 48
Average Changes in EORTC QLQ-C 30 Scale Scores Through 48 Weeks
Time Frame: Up to Week 48
EORTC QLQ-C30 is a 30-item,participant-reported multidomain questionnaire designed to assess the functioning,well-being,and symptom experience of patients with cancer.
Up to Week 48
Average Changes in FACT-An Scale Scores Through 48 Weeks
Time Frame: Up to Week 48
The FACT-An questionnaire is used to assess the effects of disease symptoms on functioning and well-being in participants with anemia.
Up to Week 48
Average Changes in FACIT-Fatigue Scale Scores Through 48 Weeks
Time Frame: Up to Week 48
The FACT-An Anemia scale includes 13 fatigue-specific items (which together comprise the FACIT-Fatigue scale).
Up to Week 48
Concentration of Study Drug in Plasma Over Time Data for Participants Treated With Elritercept
Time Frame: Pre-dose and multiple times post-dose from Cycle 1 Day 1 up to Cycle 13 Day 1 (approximately 49 weeks) (each cycle is 28 days)
Pre-dose and multiple times post-dose from Cycle 1 Day 1 up to Cycle 13 Day 1 (approximately 49 weeks) (each cycle is 28 days)
Proportion of Participants Treated with Elritercept with Antidrug Antibodies (ADA)
Time Frame: From Cycle 1 Day 1 to 60 days post last dose (approximately 5 years) (each cycle is 28 days)
From Cycle 1 Day 1 to 60 days post last dose (approximately 5 years) (each cycle is 28 days)
Time from Randomization to First Diagnosis of Acute Myeloid Leukemia (AML)
Time Frame: From Randomization to Week 48
Progression of disease to diagnosis of AML as per world health organisation (WHO) classification of ≥20 percent (%) blasts in peripheral blood or bone.
From Randomization to Week 48
Time From Randomization to the Death of a Participant From any Cause
Time Frame: From Randomization to Week 48
From Randomization to Week 48

Collaborators and Investigators

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

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 21, 2026

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

October 1, 2033

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-226-3001
  • 2025-523544-12-00 (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.

Yes

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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