MyelofibrosisPhase 3ELRISE MFNCT07623161
A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
A Phase 3 study testing Elritercept in people with Myelofibrosis and Anemia, run by Takeda at 195 sites in 31 countries.
Trial summary
The main aim of this study is to find out how well elritercept works to improve anemia in participants with myelofibrosis (MF) who are taking ruxolitinib when compared to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis, Anemia
- What is being tested?
- Elritercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 195 sitesin 31 countries
- Study dates
- 10 Sep 2026to 30 Mar 2034
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years at the time of signing the informed consent form (ICF).
- Able to understand the purpose and risks of the trial and voluntarily sign an ICF.
- Diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia (post-ET MF) or post-polycythemia vera (post-PV MF) according to the 2022 WHO criteria (WHO Classification of Tumours Editorial Board 2024), confirmed by local pathology report.
- Transfusion status as assessed in the 12 weeks immediately preceding randomization classified as Transfusion Dependent: 3 to 8 RBC units over 12 weeks.
- Receiving ruxolitinib (as approved in the country of the trial site) as the standard of care treatment for MF for at least 12 consecutive weeks, and on a stable daily dose for at least the 8 weeks immediately preceding the date of randomization.
- Eastern Cooperative Oncology Group score less than or equal to (≤) 2.
Who cannot join
- Prior treatment with luspatercept, sotatercept, or other transforming growth factor beta inhibitors or activin receptor ligand traps.
- Systemic treatment within 28 days before randomization with any of the following:
- Androgens (including danazol). Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed.
- erythropoiesis-stimulating agents.
- granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor.
- High dose corticosteroids. Participants on stable chronic steroid doses of prednisone ≤10 mg/day or corticosteroid equivalent for ≥4 weeks are allowed. Other treatments for autoimmune diseases may be allowed upon medical monitor review.
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- Hydroxyurea.
- Immunomodulatory drugs (for example, thalidomide, pomalidomide, or lenalidomide).
- Interferon.
- Thrombopoietin receptor agonists.
- Any investigational drug, including antihemojuvelin antibody. If the half-life of the investigational product is known, the exclusionary period prior to randomization is equal to 5 half-lives of the investigational product or 28 days, whichever is longer.
- Initiation of new iron chelation therapy or dose adjustments to existing iron chelation therapy ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed.
- Clinically significant anemia that is due to causes other than MF or Janus kinase (JAK) inhibitor therapy (for example, thalassemia, iron deficiency, vitamin B12 and/or folate deficiencies, autoimmune or hemolytic anemia, infections, or any active clinically significant bleeding or sequestration).
- Receipt of RBC transfusion for any reason(s) other than underlying MF within 12 weeks before randomization.
- Life expectancy <12 months per investigator's judgment.
- Clinically significant cardiovascular disease, defined as:
- New York Heart Association heart disease Class III or IV;
- Fridericia corrected QT interval >500 millisecond (ms) during screening;
- Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening.
- Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimetres of mercury (mmHg) and/or diastolic blood pressure ≥100 mmHg despite adequate treatment.
- Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.
- Prior history of malignancies, other than MF. Participants who are free of other malignant disease for ≥2 years and have completed treatment, including maintenance, are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:
- Basal or squamous cell carcinoma of the skin;
- Carcinoma in situ of the cervix;
- Carcinoma in situ of the breast; and/or
- Incidental histologic finding of prostate cancer (T1a or T1b using the Tumour, Node, and Metastasis (TNM) staging system);
- Early papillary thyroid cancer (stage I [T1-T2, N0, M0]).
- History of solid organ or bone marrow transplantation.
- Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 7 days before randomization. Prophylactic antibiotics and/or antifungals for neutropenia are allowed.
- Known positivity for Human Immunodeficiency Virus (HIV), active hepatitis B virus (HBV), or active hepatitis C virus (HCV). Participants without known history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.
- Body mass index ≥40 kilograms per square meter (kg/m^2).
- Major surgery within 28 days before randomization.
- History of allergy/anaphylaxis to recombinant proteins, investigational product, or excipients (refer to the current elritercept investigator's brochure for a list of excipients), or ruxolitinib.
- Any of the following local laboratory abnormalities:
- Absolute neutrophil count <500/microliter (μL) (0.5×109/ liter (L)).
- Platelet count <50,000/μL (50×109/L) or >1,000,000/μL (1000×109/L).
- Blasts >5% as assessed in peripheral blood at screening or ≥10% in any historical bone marrow assessments. Participants with isolated transient elevations of peripheral blood blasts may be eligible after discussion between the investigator and medical monitor to confirm the blast count is not indicative of disease progression.
- Serum aspartate aminotransferase or alanine aminotransferase ≥3× the upper limit of normal (ULN).
- Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin less than (<) 3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review.
- Estimated glomerular filtration rate <30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration equation.
- Ferritin ≤50 micrograms per liter (μg/L).
- Folate ≤2.0 nanograms per milliliter (ng/mL).
- Vitamin B12 ≤200 picograms per milliliter (pg/mL).
- Ongoing participation in another interventional clinical trial.
- Participant is unwilling or, in the opinion of the investigator, the participant is unable to comply with the requirements of the protocol.
- Is a person of childbearing potential but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of elritercept or placebo.
- Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom, during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.
- If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.
- For participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.
Trial locations and contacts
195 sites in 31 countries. Contact the study team or a site near you to ask about taking part.
195 sites in 31 countries
United States30 sites, 30 recruiting
- Not yet recruiting
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87102
Site Contact, 505-730-5526, aebaid@salud.unm.edu
Ala Ebaid
- Not yet recruiting
Emory University
Atlanta, Georgia, 30322
Site Contact, 404-778-1748, anthony.michael.hunter@emory.edu
Anthony Hunter
- Not yet recruiting
St. Vincent Regional Hospital Cancer Centers
Billings, Montana, 59101
Site Contact, 406-238-6996, patrick.cobb2@imail.org
Patrick Cobb
- Not yet recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Site Contact, 617-636-5000, Parva.Bhatt@tufts.edu
Parva Bhatt
- Not yet recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Contact, 843-792-4271, baratamp@musc.edu
Praneeth Baratam
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Site Contact, 772-297-3057, gerdsa@ccf.org
Aaron Gerds
- Recruiting
Advanced Research, LLC
Coral Springs, Florida, 33065
Site Contact, 954-726-0035, sumitsawhney@bellsouth.net
Sumit Sawhney
- Not yet recruiting
Baylor University Medical Center
Dallas, Texas, 75246
Site Contact, 214-370-1000, Micah.Burch@USOncology.com
Micah Burch
- Not yet recruiting
Duke Blood Cancer Center
Durham, North Carolina, 27705
Site Contact, 919-668-1000, lindsay.magura@duke.edu
Lindsay Rein
- Not yet recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Site Contact, 480-256-3429, mark.faber@bannerhealth.com
Mark Faber
- Not yet recruiting
Los Angeles Cancer Network
Glendale, California, 91204
Site Contact, 562-650-8875, saro.kasparian@lahomg.com
Saro Kasparian
- Not yet recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Site Contact, 713-792-7747, pbose@mdanderson.org
Prithviraj Bose
- Not yet recruiting
The University of Utah-Huntsman Cancer Institute
Houston, Texas, 77030
Site Contact, 801-213-6170, srinivas.tantravahi@hci.utah.edu
Srinivas Tantravahi
- Recruiting
LUMI Research
Houston, Texas, 77090
Site Contact, 832-553-3661, dmnguyen@lumiresearch.com
David Nguyen
- Not yet recruiting
Bioresearch Partners
Miami, Florida, 33143
Site Contact, 833-489-4968, lrangelmd@bioresearchpartner.com
Luis Rangel
- Not yet recruiting
Vanderbilt-Ingram Cancer Center (VICC)-Nashville
Nashville, Tennessee, 37232-0021
Site Contact, 615-421-8778, ashwin.kishtagari@vumc.org
Ashwin Kishtagari
- Not yet recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Site Contact, 646-608-4366, chernakb@mskcc.org
Brian Chernak
- Not yet recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Site Contact, 212-241-0463, john.mascarenhas@mssm.edu
John Mascarenhas
- Not yet recruiting
AdventHealth - Cancer Institute - Orlando
Orlando, Florida, 32804-4648
Site Contact, 407-303-2024, ahmed.zakari.md@adventhealth.com
Ahmed Zakari
- Not yet recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Site Contact, 215-955-8874, lindsay.wilde@jefferson.edu
Lindsay Wilde
- Not yet recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
Site Contact, 412-623-6037, jrossett@wpahs.org
James Rossetti
- Not yet recruiting
Allegheny Health Network Cancer Institute - West Penn Hospital Location
Pittsburgh, Pennsylvania, 15224
Site Contact, 412-578-4484, anna.koget@ahn.org
Anna Koget
- Not yet recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Site Contact, 503-494-8311, stempelj@ohsu.edu
Jessica Stempel
- Not yet recruiting
University of Washington
Seattle, Washington, 98109
Site Contact, 206-606-1978, halpern2@uw.edu
Anna Halpern
- Not yet recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Site Contact, 314-362-8814, a.zhou@wustl.edu
Amy Zhou
- Not yet recruiting
Florida Clinical Trials Group
Tamarac, Florida, 33321
Site Contact, 216-445-9840, cgandhi@floridactg.com
Chintan Gandhi
- Not yet recruiting
Moffit Cancer Center
Tampa, Florida, 33612
Site Contact, 813-745-4639, andrew.kuykendall@moffitt.org
Andrew Kuykendall
- Not yet recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Site Contact, 202-444-1289, julia.m.cunningham@gunet.georgetown.edu
Julia Cunningham
- Not yet recruiting
Cancer and Blood Specialty Clinic
Whittier, California, 90603
Site Contact, 562-698-6888, mshum@cbsclinic.com
Merrill Shum
- Not yet recruiting
Novant Health
Winston-Salem, North Carolina, 27103
Site Contact, 336-718-5570, jpdugan@novanthealth.org
James Dugan
Italy12 sites, 12 recruiting
- Not yet recruiting
Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica
Ancona, 60121
Site Contact, 715966569, e.morsia@univpm.it
Erika Morsia
- Not yet recruiting
IRCCS - AOU di Bologna - Sant Orsola Malpighi
Bologna, BO, 40138
Site Contact, 390512143044, FRANCESCA.PALANDRI@UNIBO.IT
FRANCESCA PALANDRI
- Not yet recruiting
Policlinico Universitario di Catania
Catania, 95124
Site Contact, 393283423820, ga.palumbo@tiscali.it
Giuseppe Palumbo
- Not yet recruiting
Universitaria di Ferrara Azienda Ospedaliero
Cona, Ferrara, 44124
Site Contact, 390532236825, giuseppe.auteri@ospfe.it
Giuseppe Auteri
- Not yet recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
Site Contact, 390557947824, a.vannucchi@unifi.it
Alessandro Maria Vannucchi
- Not yet recruiting
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l
Meldola, Forli-Cesena, 47014
Site Contact, 543739100, alessandro.lucchesi@irst.emr.it
Alessandro Lucchesi
- Not yet recruiting
Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano
Milan, MI, 20122
Site Contact, 390255033422, francesco.passamonti@asst-settelaghi.it
Francesco Passamonti
- Not yet recruiting
Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
Rome, Lazio, 00161
Site Contact, 649974440, breccia@bce.uniroma1.it
Massimo Breccia
- Not yet recruiting
Ospedale S Eugenio
Rome, Lazio, 144
Site Contact, 39 3387685468, elisabetta.abruzzese@uniroma2.it
Elisabetta Abruzzese
- Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, RM, 00168
Site Contact, 630154206, elena.rossi@unicatt.it
Elena Rossi
- Not yet recruiting
AOU Citta della Salute e della Scienza di Torino
Torino, 10126
Site Contact, 011 633 5504, gbenevolo@cittadellasalute.to.it
Benevolo Giulia
- Not yet recruiting
Azienda Sanitaria Universitaria Friuli Centrale
Udine, 33100
Site Contact, 559997, mario.tiribelli@asufc.sanita.fvg.it
Mario Tiribelli
India10 sites, 10 recruiting
- Not yet recruiting
Apollo Specialty Hospitals
Chennai, Tamil Nadu, 382424
Site Contact, 9818256670, nairvelu2000@yahoo.com
Velu Nair
- Not yet recruiting
Max Super Specialty Hospital
Delhi, 201012
Site Contact, 8826033518, rayazhemat@gmail.com
Rayaz Ahmed
- Not yet recruiting
Medanta- The Medicity- Gurugram
Gurgaon, Haryana, 122001
Site Contact, 9717265111, docnitinsood@yahoo.com
Nitin Sood
- Not yet recruiting
Apollo Hospital Hyderabad
Hyderabad, Telangana, 500096
Site Contact, 9553077700, drloki2002@yahoo.com
Padmaja Lokireddy
- Not yet recruiting
Amrita Institute of Medical Sciences
Kochi, Kerala, 682041
Site Contact, 9946047464, neerajsidh@gmail.com
Neeraj Sidharthan
- Not yet recruiting
Tata Medical Center, Kolkata
Kolkata, West Bengal, 700 160
Site Contact, 9051121161, arijit.nag@tmckolkata.com
Arijit Nag
- Not yet recruiting
All India Institute of Medical Science
New Delhi, National Capital Territory of Delhi, 110029
Site Contact, 9013956187, drranjitmd@gmail.com
Ranjit Sahoo
- Not yet recruiting
Sahyadri Super Speciality Hospital Deccan
Pune, Maharashtra, 411004
Site Contact, 9175980913, shashikant.apte@gmail.com
Shashikant Janardhan Apte
- Not yet recruiting
Rajiv Gandhi Cancer Institute and Research Centre
Rohini, NEW Delhi, 110085
Site Contact, 91 9971500861, bhurani@gmail.com
Dinesh Bhurani
- Not yet recruiting
Regional cancer Centre
Thiruvananthapuram, Kerala, 695011
Site Contact, 4712522565, sugeethmt2003@gmail.com
Sungeeth Thambi
France9 sites, 9 recruiting
- Not yet recruiting
Centre Hospitalier Regional Universitaire Brest Hopital Morvan
Brest, Finistere, 29609
Site Contact, 33298223786, jean-christophe.ianotto@chu-brest.fr
Jean-Christophe Ianotto
- Not yet recruiting
Centre Hospitalier Regional Universitaire de Lille
Lille, Nord, 59037
Site Contact, 3320445713, mathieu.wemeau@chu-lille.fr
Mathieu Wemeau
- Not yet recruiting
Institut Paoli Calmettes
Marseille, Bouches-du-Rhone, 13009
Site Contact, 33491223868, reyj@ipc.unicancer.fr
Jerome Rey
- Not yet recruiting
CHU de Nice
Nice, Alpes Maritimes, 6002
Site Contact, 492035558, loschi.m@chu-nice.fr
Michael Loschi
- Not yet recruiting
Assistance Publique Hopitaux de Paris
Paris, Paris, 75015
Site Contact, 33142385270, lina.benajiba@aphp.fr
Lina Benajiba
- Not yet recruiting
CHU de Bordeaux
Pessac, Gironde, 33600
Site Contact, 05 57 65 65 11, clemence.mediavilla@chu-bordeaux.fr
Clemence Mediavilla
- Not yet recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495
Site Contact, 33478861323, vincent.alcazer@chu-lyon.fr
Vincent Alcazer
- Not yet recruiting
CHU de Poitiers
Poitiers, Vienne, 86021
Site Contact, 33663601570, jose-miguel.torregrosa-diaz@chu-poitiers.fr
Jose Torregrosa Diaz
- Not yet recruiting
CHU de Strasbourg
Strasbourg, Bas Rhin, 67200
Site Contact, 03 68 76 73 01, shanti.ame@chru-strasbourg.fr
Shanti Ame
Germany9 sites, 9 recruiting
- Not yet recruiting
Praxis am Volkspark
Berlin, 10715
Site Contact, 490 30 84723535, jp.habbel@praxis-am-volkspark-berlin.de
Jan-Piet Habbel
- Not yet recruiting
Klinikum Chemnitz GmbH
Chemnitz, Saxony, 9116
Site Contact, 37133344500, m.haenel@skc.de
Mathias Hanel
- Not yet recruiting
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Site Contact, 4976127032888, heiko.becker@uniklinik-freiburg.de
Heiko Becker
- Not yet recruiting
University Hospital Halle (Saale)
Halle, Saxony-Anhalt, 06120
Site Contact, +49 345 557 7719, haifa.al-ali@uk-halle.de
Haifa Kathrin Al-Ali
- Not yet recruiting
Universitaetsklinikum Heidelberg (UKHD)
Heidelberg, Baden-Wurttemberg, 69120
Site Contact, 496221568006, tim.sauer@med.uni-heidelberg.de
Tim Sauer
- Not yet recruiting
Universitaetsklinikum Jena
Jena, Thuringia, 7743
Site Contact, 4936419324236, carl.crodel@med.uni-jena.de
Carl Crodel
- Not yet recruiting
Institut fur Versorgungsforschung in der Onkologie GbR
Koblenz, Rhineland-Palatinate, 56068
Site Contact, 261921569323, lutz@invo-koblenz.de
Cristoph Lutz
- Not yet recruiting
Muehlenkreiskliniken AoeR-Johannes Wesling Klinikum Minden - Universitaetsklinik fuer Neurologie und Neurogeriatrie
Minden, North Rhine-Westphalia, 32429
Site Contact, 57179054201, martin.griesshammer@muehlenkreiskliniken.de
Martin Griesshammer
- Not yet recruiting
Kliniken Ostalb
Mutlangen, Baden-Wurttemberg, 73557
Site Contact, 71717011302, holger.hebart@stauferklinikum.de
Holger Hebart
Brazil8 sites, 8 recruiting
- Not yet recruiting
Grupo Elora Pesquisa Clinica
Florianópolis, Santa Catarina, 88020-210
Site Contact, 4833804828, jaisson@jaissonbortolini.med.br
Jaisson Bortolini
- Not yet recruiting
Hospital Amaral Carvalho (HAC)
Jaú, São Paulo, 17210-080
Site Contact, 1436021397, pesquisafac.edersonmattos@gmail.com
Ederson Mattos
- Not yet recruiting
Centro de Hematologia e Oncologia (CHO)
Joinville, Santa Catarina, 89201-260
Site Contact, 55 47 34331849, marcelolacerda001@gmail.com
Marcelo Pitombeira de Lacerda
- Not yet recruiting
Porto Alegre Clinical Hospital (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-903
Site Contact, 555133596335, fogliattopesquisa@gmail.com
Laura Maria Fogliatto
- Not yet recruiting
Hospital Mae De Deus - Integrated Oncology Center
Porto Alegre, Rio Grande do Sul, 90110-270
Site Contact, 5133072943, marcelocapra@hotmail.com
Marcelo Capra
- Not yet recruiting
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Site Contact, 555133203005, mzschaan@hotmail.com
Mariza Schaan
- Not yet recruiting
Centro de Ensino, Pesquisa e Inovacao do Hospital Sao Lucas (CEPIN HSL RJ / Rede Americas)
Rio de Janeiro, Rio de Janeiro, 22061080
Site Contact, 5521991854223, csolza@hotmail.com
Cristiane Solza
- Not yet recruiting
Portuguese Charity of Sao Paulo
São Paulo, 01323-900
Site Contact, 113505-5022, scheinbp@gmail.com
Phillip Scheinberg
Japan8 sites, 8 recruiting
- Not yet recruiting
Tokyo Metropolitan Komagome Hospital
Bunkyo-Ku, Tokyo, 113-8677
Site Contact, 3-3823-2101, n-doki@cick.jp
Noriko Doki
- Not yet recruiting
Chiba Cancer Center
Chiba, Chiba, 260-8717
Site Contact, 81-43-264-5431, mtakeuchi@chiba-cc.jp
Masahiro Takeuchi
- Not yet recruiting
University of Yamanashi Hospital
Chuo-shi, Yamanashi, 409-3898
Site Contact, 81-55-273-1111, kirito@yamanashi.ac.jp
Keita Kirito
- Not yet recruiting
Hitachi General Hospital
Hitachi, Ibaraki, 317-0077
Site Contact, 81-294-23-1111, chikenkanriishi2.nichibyo.fd@hitachi.com
Atsushi Shinagawa
- Not yet recruiting
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
Site Contact, 78-302-4321
Yuya Nagai
- Not yet recruiting
University of Miyazaki Hospital
Miyazaki, Miyazaki, 889-1692
Site Contact, 81-985-85-1510
Kazuya Shimoda
- Not yet recruiting
Ehime University Hospital
Toon-shi, Ehime, 791-0295
Site Contact, 81-89-964-5111, takenaka.katsuto.hy@ehime-u.ac.jp
Katsuto Takenaka
- Not yet recruiting
Mie University Hospital
Tsu, Mie-ken, 514-8507
Site Contact, 81(0)59-232-1111
Yuka Sugimoto
Spain8 sites, 8 recruiting
- Not yet recruiting
Institut Catala d'Oncologia
Badalona, Barcelona, 8916
Site Contact, 34934978387, bxicoy@iconcologia.net
Blanca Xicoy Cirici
- Not yet recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Site Contact, 93 274 61 00, laura.fox@vallhebron.cat
Maria Laura Fox
- Not yet recruiting
Institut Catala d'Oncologia Hospital Duran y Renals
L'Hospitalet de Llobregat, Barcelona, 08908
Site Contact, 34638006377, jvillarreal@iconcologia.net
Jasson Villarreal
- Not yet recruiting
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, LAS Palmas, 35010
Site Contact, 34928450849, adsegura@hotamil.com
Adrian Segura Diaz
- Not yet recruiting
Hospital Ramon Y Cajal
Madrid, 28034
Site Contact, 607808354, jvalentingg@gmail.com
Jose Valentin Garcia-Gutierrez
- Not yet recruiting
Hospital Universitario Virgen de la Victoria
Málaga, M, 29003
Site Contact, 607808354, reginagarciadel@yahoo.es
Regina Garcia-Delgado
- Not yet recruiting
Universidad de Salamanca - Hospital Universitario de Salamanca
Salamanca, 37007
Site Contact, 626308549, jmhr@usal.es
Jesus Maria Hernandez Rivas
- Not yet recruiting
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Site Contact, 34961224190, mora_elv@gva.es
Elvira Mora Castera
South Korea7 sites, 7 recruiting
- Not yet recruiting
Daegu Catholic University Medical Center
Daegu, 42472
Site Contact, 821065709310, sunghwa@cu.ac.kr
Sung Hwa Bae
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Site Contact, 1027609350, smbang7@snu.ac.kr
Soo-Mee Bang
- Not yet recruiting
Samsung Medical Center
Seoul, Gangnam-gu
Site Contact, 6398, chulwon1.jung@samsung.com
Chul Won Jung
- Not yet recruiting
Korea University Anam Hospital
Seoul, Seongbuk-gu
Site Contact, 821064985856, ypark@augusta.edu
Yong Park
- Not yet recruiting
Soon Chun Hyang University Hospital Seoul
Seoul, Seoul Teugbyeolsi, 04401
Site Contact, 11476, ysy6496@schmc.ac.kr
Seug Yun Yoon
- Not yet recruiting
The Catholic University of Korea
Seoul, 137-701
Site Contact, 821047144486, lee86@catholic.ac.kr
Sung-Eun Lee
- Not yet recruiting
Seoul National University Hospital
Seoul, 3080
Site Contact, 82 2 2072 3383, hongjblood@snu.ac.kr
Junshik Hong
United Kingdom7 sites, 7 recruiting
- Not yet recruiting
Birmingham Heartlands Hospital
Birmingham, W Mids
Site Contact, 7739514452, Joanne.ewing@uhb.nhs.uk
Joanne Ewing
- Not yet recruiting
University Hospital of Leicester NHS
Leicester, Leicestershire, LE1 5WW
Site Contact, 7790383653, mamta.garg1@nhs.net
Mamta Garg
- Not yet recruiting
United Lincolnshire Teaching Hospitals NHS Trust
Lincoln, East Midlands, LN2 5QY
Site Contact, 15225512512, ciro.rinaldi@ulh.nhs.uk
Ciro Rinaldi
- Not yet recruiting
Imperial College Healthcare NHS Trust
London, London, City of, W12 0HS
Site Contact, 2037048452, simone.claudiani@nhs.net
Simone Claudiani
- Not yet recruiting
UCL Cancer Institute - University College London Hospitals NHS Foundation Trust
London, NW1 2PG
Site Contact, 7813784295, jonathan.lambert@uclh.nhs.uk
Jonathan Lambert
- Not yet recruiting
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London, SE1 9RT
Site Contact, 7939059512, Claire.Harrison@gstt.nhs.uk
Claire Harrison
- Not yet recruiting
Sunderland and South Tyneside NHS Foundation Trust
Sunderland, Tyne and Wear, SR4 7TP
Site Contact, 1915656256, scott.marshall3@nhs.net
Scott Marshall
Argentina6 sites, 6 recruiting
- Not yet recruiting
Swiss Medical Center Barrio Parque
Buenos Aires, Ciudad Autonoma de BuenosAires, 1405
Site Contact, 5491169816300, miastrebner@gmail.com
Claudio Marcelo Iastrebner
- Not yet recruiting
Hospital Aleman (HA) Deutsches Hospital
Buenos Aires, CPC1118AAT
Site Contact, 541148277000, mvicente@hospitalaleman.com
Maria De Los Angeles Vicente Reparaz
- Not yet recruiting
BRCR Global
Córdoba, 5000
Site Contact, 1 561 4470614 EXT. 140, dubersarsky.md@brcrglobal.com
Karla Di Sisto
- Not yet recruiting
Hospital Universitario Austral
Pilar, Buenos Aires, B1629AHJ
Site Contact, 5491138322920, scarrico@cas.austral.edu.ar
Silvio Carricondo
- Not yet recruiting
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, Santa Fe Province, 2000
Site Contact, 5493416149225, gustavobraidot@consultoriosintegrados.org
Gustavo Jorge Braidot
- Not yet recruiting
Hospital Privado de Rosario
Rosario, Santa Fe Province, S2000GAP
Site Contact, -3748398, joselfedele@gmail.com
Jose Luis Fedele
Greece6 sites, 6 recruiting
- Not yet recruiting
Laiko General Hospital of Athens
Athens, Attica, 11526
Site Contact, 302132060962, theopvass@hotmail.com
Theodoros Vassilakopoulos
- Not yet recruiting
General Hospital
Athens, Attica, 11527
Site Contact, 6976776260, pandiamantopoulos@gmail.com
Panagiotis Diamantopoulos
- Not yet recruiting
Alexandra General Hospital of Athens
Athens, Attica, 11528
Site Contact, 30 213 216 2540-41, mdimop@med.uoa.gr
Meletios-Athanasios Dimopoulos
- Not yet recruiting
University of Crete
Heraklion, Crete, 70013
Site Contact, 306937045324, nikolaos.sousos@uoc.gr
Nikolaos Sousos
- Not yet recruiting
Olympion General Clinic & Rehabilitation Center
Pátrai, Ahaia, 264 43
Site Contact, 6944960012, argiris.symeonidis@yahoo.gr
Argiris Symeonidis
- Not yet recruiting
Ippokrateion Hospital of Thessaloniki
Thessaloniki, Macedonia, 54642
Site Contact, 6973841671, elenicelli@yahoo.gr
Eleni Gavriilaki
Poland6 sites, 6 recruiting
- Not yet recruiting
Zespol Szpitali Miejskich w Chorzowie
Chorzów, Silesian Voivodeship, 41-500
Site Contact, 500198314, piotr.malecki86@gmail.com
Piotr Malecki
- Not yet recruiting
Pratia Oncology Katowice
Katowice, Silesian Voivodeship, 40-519
Site Contact, 48 600388282, sgrosicki@wp.pl
Sebastian Grosicki
- Not yet recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Hematologii
Lodz, Łódź Voivodeship, 93-513
Site Contact, 48691461010, joannagora@op.pl
Joanna Gora-Tybor
- Not yet recruiting
Pratia Poznan
Poznan, Greater Poland Voivodeship, 60-192
Site Contact, 48616299430, anna.hoppe@pratia.com
Anna Hoppe
- Not yet recruiting
Wojewodzki Szpital Zespolony Im L Rydygiera
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
Site Contact, 48608654777, drchraniuk@gmail.com
Dominik Chraniuk
- Not yet recruiting
MTZ Clinical Research Powered by PRATIA
Warsaw, Masovian Voivodeship, 02-172
Site Contact, 48225725959, kmadry@wum.edu.pl
Krzysztof Madry
Belgium5 sites, 5 recruiting
- Not yet recruiting
Ziekenhuis aan de Stroom-Cadix
Antwerp, 2030
Site Contact, +32 3 217 72 57, nikki.granacher@zas.be
Nikki Granacher
- Not yet recruiting
Centre Hospitalier Jolimont-Lobbes
La Louvière, Hainaut, 7100
Site Contact, FlorenceCuscheraflorence.cuschera@helora.be
Florence Cuschera
- Not yet recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Site Contact, 3216346880, timothy.devos@uzleuven.be
Timothy Devos
- Not yet recruiting
AZ Delta
Roeselare, West-Vlaanderen, 8800
Site Contact, 51237322, lien.deleu@azdelta.be
Lien Deleu
- Not yet recruiting
CHU Namur Site Mont Godinne
Yvoir, 5530
Site Contact, 3281423865, julien.devreux@chuuclnamur.uclouvain.be
Julien Devreux
Chile5 sites, 5 recruiting
- Not yet recruiting
Hospital Cliniico Regional de Concepcion Dr
Concepción, Biobio, 4030000
Site Contact, 56979883460, monalejomero@yahoo.es
Monica Romero
- Not yet recruiting
IC La Serena Research
La Serena, Coquimbo Region, 01697
Site Contact, 945481789, cleiden.villegas@iclsr.cl
Cleiden Villegas
- Not yet recruiting
Immunocel
Las Condes, Santiago Metropolitan, 7560908
Site Contact, 997890202, aberkovits@inmunocel.com
Alejandro Berkovits
- Not yet recruiting
Icegclinic
Santiago, La Florida, 8241479
Site Contact, 56944347482, cavendano@icegclinic.com
Carlos Avendano
- Not yet recruiting
Centro de Oncologia de Precision
Santiago, Santiago Metropolitan, 7850000
Site Contact, 973794261, icorvalan@celerityclinical.cl
Ignacio Corvalan
Israel5 sites, 5 recruiting
- Not yet recruiting
Rambam Health Care Campus
Haifa, North, 3109601
Site Contact, 502063132, i_tzoran@rmc.gov.il
Inna Tzoran
- Not yet recruiting
Carmel Medical Center
Haifa, 3436212
Site Contact, 502063132, elenahi@clalit.org.il
Elena Mishchenko
- Not yet recruiting
Hadassah Medical Organization, Hadassah Medical Center, Ein-
Jerusalem, 9112001
Site Contact, 972587785363, davidla@hadassah.org.il
David Lavie
- Not yet recruiting
Rabin Medical Center
Petah Tikva, 4941492
Site Contact, 972543040797, shacham.adi@gmail.com
Adi Shacham-Abulafia
- Not yet recruiting
The Tel Aviv Sourasky Medical Center
Tel Aviv, TLV, 64239
Site Contact, 97236973576, ilyak@tasmc.health.gov.il
Ilya Kirgner
Taiwan5 sites, 5 recruiting
- Not yet recruiting
Kaohsiung Medical University Hospital
Kaohsiung City
Site Contact, 886936805375, ycliu@kmu.edu.tw
Yi-Chang Liu
- Not yet recruiting
Taichung Veterans General Hospital
Taichung, 40705
Site Contact, 0921861369, tjchen9477@gmail.com
Tsung Chih Chen
- Not yet recruiting
National Cheng Kung University Hospital
Tainan, 70403
Site Contact, 936257054, teresa@mail.ncku.edu.tw
Tsai-Yun Chen
- Not yet recruiting
Taipei Veterans General Hospital
Taipei, Beitou, 11217
Site Contact, 886-2-28712121 ext: 65716, ccchen1968@gmail.com
Chih-Cheng Chen
- Not yet recruiting
National Taiwan University Hospital
Taipei, Taiwan (r.o.c.), 100
Site Contact, 0972653089, hsinanhou@gmail.com
Hsin-An Hou
Australia4 sites, 4 recruiting
- Not yet recruiting
Flinders Medical Centre
Bedford Park, Adelaide, SA, 5042
Site Contact, 0882046293, david.ross@health.sa.gov.au
David Ross
- Not yet recruiting
Mid North Coast Cancer Institute (MNCCI)
Coffs Harbour, New South Wales, 2450
Site Contact, 0439119527, kyle.crassini@health.nsw.gov.au
Kyle Crassini
- Not yet recruiting
Tweed Valley Hospital
Cudgen, New South Wales, 2487
Site Contact, 61266773097, steven.wong@health.nsw.gov.au
Steven Wong
- Not yet recruiting
South Eastern Sydney Local Health District
Kogarah, New South Wales, 2217
Site Contact, 61291131111, sundra.ramanathan@health.nsw.gov.au
Sundreswran (Sundra) Ramanathan
Austria4 sites, 4 recruiting
- Not yet recruiting
Medizinische Universitat Innsbruck
Innsbruck, Tyrol, 6020
Site Contact, 51250424003, dominik.wolf@i-med.ac.at
Dominik Wolf
- Not yet recruiting
Ordensklinikum Linz Elisabethinen
Linz, 4020
Site Contact, 4373276760, veronika.buxhofer-ausch@ordensklinikum.at
Veronika Buxhofer-Ausch
- Not yet recruiting
Medizinische Universitat Wien (Medical University of Vienna - Austria)
Vienna, A, 1090
Site Contact, 0043 1 40400 44100, maria.krauth@meduniwien.ac.at
Maria-Theresa Krauth
- Not yet recruiting
Klinikum Wels-Grieskirchen
Wels, Upper Austria, 4600
Site Contact, 43 7242 415 3452, sonja.heibl@klinikum-wegr.at
Sonja Heibl
Bulgaria4 sites, 4 recruiting
- Not yet recruiting
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, 5800
Site Contact, 359887450850, slavcheva_v@yahoo.com
Vanya Slavcheva-Popova
- Not yet recruiting
Dr. Pencho Georgiev - Outpatient Center
Plovdiv, 4002
Site Contact, 359888520139, penchogeorgiev@yahoo.com
Pencho Georgiev
- Not yet recruiting
UMHAT Sv. Ivan Rilski
Sofia, 1431
Site Contact, 359884933151, aradinoff@hotmail.com
Atanas Radinoff
- Not yet recruiting
Specialized Hospital for Active Treatment of Haematological Diseases - Sofia
Sofia, 1797
Site Contact, 359877676134, martin.donchev@abv.bg
Martin Donchev
Canada4 sites, 4 recruiting
- Not yet recruiting
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Site Contact, 905 387 9495, hillis@hhsc.ca
Hillis Christopher
- Not yet recruiting
Jewish General Hospital
Montreal, Quebec, H3T1E2
Site Contact, 514-340-8222 ext 23293, shireen.sirhan@mail.mcgill.ca
Shireen Sirhan
- Not yet recruiting
McGill University Health Center
Montreal, Quebec, H4A 3J1
Site Contact, 5149341934, jonathan.how@muhc.mcgill.ca
Jonathan How
- Not yet recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Site Contact, 4169464501, dawn.maze@uhn.ca
Dawn Maze
Colombia4 sites, 4 recruiting
- Not yet recruiting
Clinica General del Norte De Barranquilla
Barranquilla, Atlántico, 080002
Site Contact, 3058130222, arturo.guzman@zentria.com.co
Arturo Guzman
- Not yet recruiting
Funcacion santa Fe De Bogota
Bogota, Cundinamarca, 11011
Site Contact, 57 3118028204, claudia.agudelo@fsfb.org.co
Claudia Agudelo
- Not yet recruiting
Los Cobos Medical Center
Bogotá, Bogota D.C., 110121
Site Contact, 3015917907, jheremyreyesmd@gmail.com
Jheremy Reyes
- Not yet recruiting
Hospital Pablo Tobon Uribe
Medellín, Antioquia, 0000000
Site Contact, 3148905603, kennygalvez@gmail.com
Kenny Galvez
Czechia4 sites, 4 recruiting
- Not yet recruiting
Masaryk University Hospital Brno, Department of Internal Medicine, Hematology and Oncology
Brno, Czech Republic, 625 00
Site Contact, 420532233642, Weinbergerova.Barbora@fnbrno.cz
Barbora Weinbergerova
- Not yet recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, CZ, 50005
Site Contact, 420495833837, petra.belohlavkova@fnhk.cz
Petra Belohlavkova
- Not yet recruiting
Vseobecna fakultni nemocnice Praha
Prague, CZ, 12808
Site Contact, 224966209, anna.jonasova@vfn.cz
Anna Jonasova
- Not yet recruiting
Fakultni nemocnice Kralovske Vinohrady
Prague, 134 00
Site Contact, 267162887, Olga.cerna@fnkv.cz
Olga Cerna
Ireland4 sites, 4 recruiting
- Not yet recruiting
Cork University Hospital
Cork, T12 DC4A
Site Contact, 866039097, ckeohane@muh.ie
Clodagh Keohane
- Not yet recruiting
St James's Hospital
Dublin, D08 NHY1
Site Contact, 14103000, cmflynn@stjames.ie
Catherine Flynn
- Not yet recruiting
Mater Misericordiae University Hospital
Dublin, D15 W8Y7
Site Contact, 877724026, SuMaung@mater.ie
Su Maung
- Not yet recruiting
University Hospital Galway
Galway, H91YR71
Site Contact, 91898877, janusz.krawczyk@hse.ie
Janusz Krawczyk
Malaysia4 sites, 4 recruiting
- Not yet recruiting
Hospital Ampang
Ampang, Selangor, 68000
Site Contact, 163915825, veena_263@yahoo.com
Veena Selvaratnam
- Not yet recruiting
Hospital Pulau Pinang
George Town, Pulau Pinang, 10990
Site Contact, 60124281842, liewhongkeng@gmail.com
Hong Keng Liew
- Not yet recruiting
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, 88586
Site Contact, 164690115, khaiteri87@gmail.com
Khaiteri Raghunathan
- Not yet recruiting
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
Site Contact, 03-79492952, edmund@ummc.edu.my
Edmund Fui Min Chin
Romania4 sites, 4 recruiting
- Not yet recruiting
Colentina Clinical Hospital
Bucharest, 20125
Site Contact, 734371821, tevetmihaela@gmail.com
Mihaela Andreescu
- Not yet recruiting
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, CJ, 400124
Site Contact, 40741337480, ciprian.tomuleasa@gmail.com
Ciprian Tomuleasa
- Not yet recruiting
Spitalul Municipal Filantropia Craiova
Craiova, Dolj, 200143
Site Contact, 735439439, diaconu_luminita@yahoo.com
Luminita Ocroteala
- Not yet recruiting
Spitalul Clinic Municipal de Urgenta Timisoara
Timișoara, 300700
Site Contact, 40723353484, mdioanaionita@yahoo.com
Ioana Ionita
Turkey (Türkiye)4 sites, 4 recruiting
- Not yet recruiting
Ankara Bilkent City Hospital
Çankaya, Ankara, 06800
Site Contact, 905052458374, drmpamuk@yahoo.com
Marve Pamukcuoglu
- Not yet recruiting
Istanbul University-CerrahpaAYa, CerrahpaAYa Faculty of Medicine
Istanbul, 34303
Site Contact, 905337227376, emre.eskazan@iuc.edu.tr
Ahmet Emre Eskazan
- Not yet recruiting
Istanbul Florence Nightingale Hospital
Istanbul, 34381
Site Contact, 5437870708, omurgok17@hotmail.com
Omur Sevindik
- Not yet recruiting
VM Medical Park Mersin Hospital
Mersin, Mezitli, 33000
Site Contact, 905323460767, aniltombak@hotmail.com
Anil Tombak
Mexico3 sites, 3 recruiting
- Not yet recruiting
Hematologica Alta Especialidad S.C.
Huixquilucan, Mexico de Mexico, 52787
Site Contact, 5521291399, ovillarob@gmail.com
Roberto Ovilla Martinez
- Not yet recruiting
Universidad Autonoma de Nuevo Leon
Monterrey, Mexic, 64710
Site Contact, 8183470002, dgomezalmaguer@gmail.com
David Gomez Almaguer
- Not yet recruiting
OSMO - Oaxaca Site Management Organization S.C
Oaxaca City, Oaxaca, 68000
Site Contact, 951 5147056, eva.ramirez@osmomexico.com
Eva Ramirez Romero
Hungary2 sites, 2 recruiting
- Not yet recruiting
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika
Debrecen, HB, 4032
Site Contact, 3652255196, illesarpaddr@gmail.com
Arpad Illes
- Not yet recruiting
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, Komarom-Esztergom VArmegye, 2800
Site Contact, 36204119459, zsocogo@gmail.com
Zsofia Simon
Saudi Arabia2 sites, 2 recruiting
- Not yet recruiting
King Faisal Specialist Hospital & Research Centre Riyadh
Riyadh, 11211
Site Contact, 966505148919, dr_marwan1@hotmail.com
Marwan Shaheen
- Not yet recruiting
King Khalid University Hospital
Riyadh, 12372
Site Contact, 966566041113, malzahrani@ksu.edu.sa
Musa Alzahrani
Sweden2 sites, 2 recruiting
- Not yet recruiting
Orebro University Hospital
Örebro, 70185
Site Contact, 196021543, erik.ahlstrand@regionorebrolan.se
Erik Ahlstrand
- Not yet recruiting
Karolinska University Hospital
Stockholm, 14186
Site Contact, 812380000, anne-marie.landtblom@liu.se
Anne-Marie Landtblom
About this study
Official title: A Phase 3, Double-Blind, Randomized Trial Evaluating the Efficacy and Safety of Elritercept (TAK-226) Compared to Placebo in Participants With Myelofibrosis and Anemia on Concurrent Ruxolitinib Therapy
The main aim of this study is to find out how well elritercept works to improve anemia in participants with myelofibrosis (MF) who are taking ruxolitinib when compared to placebo.
Other aims are to learn how elritercept improves anemia compared to placebo; to learn if elritercept reduces tiredness, improves symptoms related to MF, and helps participants do physical activities more easily. The study also aims to find out how elritercept affects the bone marrow, the spleen, and whether participants develop antibodies to the study drug.
The study will also check how safe elritercept is compared to placebo, and if elritercept stays safe over a long period of time. Participants will receive study treatment for at least 9 months (36 weeks). After this period, participants who received placebo will have the option to switch to elritercept.
- Conditions
- Myelofibrosis, Anemia
- Being tested
- Placebo, Elritercept
- Keywords
- TAK-226, Drug therapy
- Medical subject headings
- Primary Myelofibrosis, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Elritercept-matching placebo
ElriterceptDrug
Also called TAK-226
Elritercept, SC, injection
| Study group | Role | What they receive |
|---|---|---|
| Elritercept | Experimental | Participants will receive elritercept at a starting dose of 3.75 milligrams per kilogram (mg/kg) subcutaneously (SC) once every 4 weeks (Q4W) on Day 1 of each 28-day cycle for approximately 36 weeks during the double-blinded treatment period, with possible up-titration to 5.0 mg/kg from Cycle 3 Day 1 based on response and safety/tolerability. Participants may continue to receive elritercept during the extended open-label treatment period. Receives: Drug: Elritercept |
| Placebo | Placebo comparator | Participants will receive elritercept-matching placebo with equivalent volume to elritercept SC Q4W on Day 1 of each 28-day cycle for approximately 36 weeks during the double-blinded treatment period. Eligible participants may initiate elritercept at a starting dose of 3.75 mg/kg SC Q4W on Day 1 of each 28-day cycle during the extended open-label treatment period, with possible up-titration to 5.0 mg/kg after 2 cycles, based on response and safety/tolerability. Receives: Drug: Placebo; Drug: Elritercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Who Are Red Blood Cell-Transfusion Independent (RBC-TI) for Any Consecutive Greater Than or Equal to (≥) 12-Week Period During the 36-Week Double-Blinded Treatment Period
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Secondary outcomes (30)
Proportion of Participants Who Achieve ≥50 Percent (%) Reduction in RBC Transfusion Burden From Baseline Over Any Consecutive 12-Week Period
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Who Are RBC-TI for Any Consecutive ≥16-Week Period
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Who Are RBC-TI for Any Consecutive ≥12-Week Period With Concurrent Mean Hemoglobin (Hgb) Increase ≥1.5 Grams per Deciliter (g/dL) From Baseline
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Who Are RBC-TI for Any Consecutive ≥24-Week Period
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Who Are RBC-TI for Any Consecutive ≥12-Week Period With Concurrent Mean Hgb Increase of ≥1.0 g/dL and ≥2.0 g/dL From Baseline
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Who Are RBC-TI for Any Consecutive 16- or 24-Week Period With a Concurrent Mean Hgb Increase of ≥1.0 g/dL, ≥1.5 g/dL, and ≥2.0 g/dL From Baseline
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Maximum Duration of RBC-TI for Participants Who Achieved RBC-TI for a Consecutive ≥12 Weeks
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Maximum Duration of RBC-TI With Concurrent Mean Hgb Increase of ≥1.5 g/dL for Participants Who Achieved Consecutive ≥12 Weeks RBC-TI With Concurrent Mean Hgb Increase of ≥1.5 g/dL
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Time to Onset of Anemia Response
Time to onset of anemia response is defined as the duration between the date of randomization and the date participant first achieved anemia response status. Anemia response is evaluated as: achievement of RBC-TI for any consecutive ≥12-week, ≥16-week, or ≥24-week period or ≥50% reduction in red blood cell transfusion burden from baseline over any consecutive 12 weeks.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Fatigue 7a T-Score at Week 36
PROMIS Short Form v1.0 - Fatigue 7a is a 7-item, patient-reported measure designed to assess fatigue symptoms and impact over the past 7 days. Response options are on a 5-point scale from never (1) to always (5). Raw scores are computed by summing responses to all 7 items and then converted to a standardized T-score on a scale from 0 to 100 with a mean of 50 and SD of 10 with higher scores representing worse fatigue. T-scores can be produced using a conversion table available from the instrument developer or using response pattern scoring performed by the Health Measures Scoring Service.
Measured: Baseline, Week 36
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue Scale Score at Week 36
EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participants with cancer. The questionnaire's items are divided among 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social), 3 multi-item scales measuring symptoms (fatigue, nausea/vomiting, and pain), 6 items measuring symptoms (dyspnea, insomnia, appetite loss, constipation, and diarrhea) as well as financial difficulties, and a 2-item scale measuring global health status (GHS))/quality of life (QoL). Items included in GHS/QoL scale use a 7-point response metric ranging from very poor to excellent, while other items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning, GHS/QoL, or worse symptomatology.
Measured: Baseline, Week 36
Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in PROMIS Short Form v1.0 - Fatigue 7a T-score
PROMIS Short Form v1.0 - Fatigue 7a is a 7-item, patient-reported measure designed to assess fatigue symptoms and impact over the past 7 days. Response options are on a 5-point scale from never (1) to always (5). Raw scores are computed by summing responses to all 7 items and then converted to a standardized T-score on a scale from 0 to 100 with a mean of 50 and SD of 10 with higher scores representing worse fatigue. T-scores can be produced using a conversion table available from the instrument developer or using response pattern scoring performed by the Health Measures Scoring Service. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Time to Meaningful Improvement and Meaningful Deterioration in PROMIS Short Form v1.0 - Fatigue 7a T-Score From Baseline
PROMIS Short Form v1.0 - Fatigue 7a is a 7-item, patient-reported measure designed to assess fatigue symptoms and impact over the past 7 days. Response options are on a 5-point scale from never (1) to always (5). Raw scores are computed by summing responses to all 7 items and then converted to a standardized T-score on a scale from 0 to 100 with a mean of 50 and SD of 10 with higher scores representing worse fatigue. T-scores can be produced using a conversion table available from the instrument developer or using response pattern scoring performed by the Health Measures Scoring Service. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Fatigue Scale Score
EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The items are divided among 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social), 3 multi-item scales measuring symptoms (fatigue, nausea/vomiting, pain), 6 items measuring symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) as well as financial difficulties, and a 2-item scale measuring GHS and QoL. Items included in GHS/QoL scale use a 7-point response metric ranging from very poor to excellent, while other items use a 4-point response metric, categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning, better GHS/QoL, or worse symptomatology. Score cutoffs to define meaningful improvement/deterioration to be determined before primary analysis.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Time to Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Fatigue Scale Score From Baseline
EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The items are divided among 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, social), 3 multi-item scales measuring symptoms (fatigue, nausea/vomiting, pain), 6 items measuring symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) as well as financial difficulties, and a 2-item scale measuring GHS and QoL. Items included in GHS/QoL scale use a 7-point response metric ranging from very poor to excellent, while other items use a 4-point response metric, categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning, better GHS/QoL, or worse symptomatology. Score cutoffs to define meaningful improvement/deterioration to be determined before primary analysis.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Mean Changes From Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 7-Item Total Symptom Score at Week 36
MFSAF v4.0 is a unidimensional measure assessing 7 core MF symptoms: fatigue, night sweats, itching, abdominal discomfort, pain under ribs, early satiety, and bone pain. The questionnaire asks participants to rate each symptom at its worst during the past 7 days on a 0 to 10 numeric rating scale ranging from absent (0) to worst imaginable (10). The Total Symptom Score (TSS) is calculated as the average of the 7 individual item responses multiplied by 7, yielding a score range of 0 to 70 with higher scores representing worse symptom severity.
Measured: Baseline, Week 36
Proportion of Participants Achieving Confirmed 50% Reduction in MFSAF v4.0 Total Symptom Score (TSS50)
MFSAF v4.0 is a unidimensional measure assessing 7 core MF symptoms: fatigue, night sweats, itching, abdominal discomfort, pain under ribs, early satiety, and bone pain. The questionnaire asks participants to rate each symptom at its worst during the past 7 days on a 0 to 10 numeric rating scale ranging from absent (0) to worst imaginable (10). The TSS is calculated as the average of the 7 individual item responses multiplied by 7, yielding a score range of 0 to 70 with higher scores representing worse symptom severity.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Time to Symptom Response in MFSAF TSS50 From Baseline
MFSAF v4.0 is a unidimensional measure assessing 7 core MF symptoms: fatigue, night sweats, itching, abdominal discomfort, pain under ribs, early satiety, and bone pain. The questionnaire asks participants to rate each symptom at its worst during the past 7 days on a 0 to 10 numeric rating scale ranging from absent (0) to worst imaginable (10). The TSS is calculated as the average of the 7 individual item responses multiplied by 7, yielding a score range of 0 to 70 with higher scores representing worse symptom severity.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Mean Change From Baseline EORTC QLQ-C30 Physical Functioning Scale Score at Week 36
EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The questionnaire's items include 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social). These items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning.
Measured: Baseline, Week 36
Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Physical Functioning Scale Score
EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The questionnaire's items include 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social). These items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Time to Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Physical Functioning Scale Score From Baseline
EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The questionnaire's items include 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social). These items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants With Platelet Response During the 36-Week Double-Blinded Treatment Period
Platelet response includes a mean increase of ≥30×10^9/ liter (L) from baseline, a >50% increase from baseline with a count ≥50×10^9/L, and conversion from <100 to ≥100×10^9/L, each sustained for ≥12 weeks.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Achieving Spleen Volume Reduction (SVR) From Baseline as Measured by Computed Tomography/Magnetic Resonance Imaging (CT/MRI) During the 36-Week Double-Blinded Treatment Period
Proportion of participants achieving SVR of ≥10%, ≥25%, or ≥35% will be presented for this outcome measure.
Measured: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Who Develop Accelerated Phase (AP) MF
Measured: Up to approximately 7 years
Time to Progression in Participants Who Develop AP MF
Measured: Up to approximately 7 years
Proportion of Participants Who Develop Blast Phase (BP) MF
Measured: Up to approximately 7 years
Time to Progression in Participants Who Develop BP MF
Measured: Up to approximately 7 years
Plasma Concentration-Time Data for Participants Treated With Elritercept
Measured: At multiple time points from Cycle 1 Day 1 (each cycle is 28 days) up to approximately 7 years
Proportion of Participants Treated With Elritercept who Have Antidrug Antibodies
Measured: At multiple time points from Cycle 1 Day 1 (each cycle is 28 days) up to approximately 7 years
Overall Survival (OS)
OS is defined as the time from randomization to the date of death due to any cause.
Measured: From randomization to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start10 Sep 2026
- Primary completion7 Dec 2029 (estimated)
- Study completion30 Mar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623161
- Sponsor's protocol ID
- TAK-226-3002
- Other IDs
- 2026-525660-17-00
- Acronym
- ELRISE MF
- Status last verified
- Sep 2026
- First submitted
- 29 May 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.