RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Takeda • ClinicalTrials.gov ID: NCT07623161

Registry updated: 2026-10-01

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Description

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.

Interventions

Placebo (Drug)
Elritercept-matching placebo
Elritercept (Drug)
Elritercept, SC, injection

Eligibility criteria

Inclusion Criteria: 1. Aged ≥18 years at the time of signing the informed consent form (ICF). 2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF. 3. Diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia (post-ET MF) or post-polycythemia vera (post-PV MF) according to the 2022 WHO criteria (WHO Classification of Tumours Editorial Board 2024), confirmed by local pathology report. 4. Transfusion status as assessed in the 12 weeks immediately preceding randomization classified as Transfusion Dependent: 3 to 8 RBC units over 12 weeks. 5. Receiving ruxolitinib (as approved in the country of the trial site) as the standard of care treatment for MF for at least 12 consecutive weeks, and on a stable daily dose for at least the 8 weeks immediately preceding the date of randomization. 6. Eastern Cooperative Oncology Group score less than or equal to (≤) 2. Exclusion Criteria: 1. Prior treatment with luspatercept, sotatercept, or other transforming growth factor beta inhibitors or activin receptor ligand traps. 2. Systemic treatment within 28 days before randomization with any of the following: 1. Androgens (including danazol). Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed. 2. erythropoiesis-stimulating agents. 3. granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor. 4. High dose corticosteroids. Participants on stable chronic steroid doses of prednisone ≤10 mg/day or corticosteroid equivalent for ≥4 weeks are allowed. Other treatments for autoimmune diseases may be allowed upon medical monitor review. 5. Hydroxyurea. 6. Immunomodulatory drugs (for example, thalidomide, pomalidomide, or lenalidomide). 7. Interferon. 8. Thrombopoietin receptor agonists. 9. Any investigational drug, including antihemojuvelin antibody. If the half-life of the investigational product is known, the exclusionary period prior to randomization is equal to 5 half-lives of the investigational product or 28 days, whichever is longer. 3. Initiation of new iron chelation therapy or dose adjustments to existing iron chelation therapy ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed. 4. Clinically significant anemia that is due to causes other than MF or Janus kinase (JAK) inhibitor therapy (for example, thalassemia, iron deficiency, vitamin B12 and/or folate deficiencies, autoimmune or hemolytic anemia, infections, or any active clinically significant bleeding or sequestration). 5. Receipt of RBC transfusion for any reason(s) other than underlying MF within 12 weeks before randomization. 6. Life expectancy \<12 months per investigator's judgment. 7. Clinically significant cardiovascular disease, defined as: 1. New York Heart Association heart disease Class III or IV; 2. Fridericia corrected QT interval \>500 millisecond (ms) during screening; 3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening. 8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimetres of mercury (mmHg) and/or diastolic blood pressure ≥100 mmHg despite adequate treatment. 9. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed. 10. Prior history of malignancies, other than MF. Participants who are free of other malignant disease for ≥2 years and have completed treatment, including maintenance, are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy: 1. Basal or squamous cell carcinoma of the skin; 2. Carcinoma in situ of the cervix; 3. Carcinoma in situ of the breast; and/or 4. Incidental histologic finding of prostate cancer (T1a or T1b using the Tumour, Node, and Metastasis (TNM) staging system); 5. Early papillary thyroid cancer (stage I \[T1-T2, N0, M0\]). 11. History of solid organ or bone marrow transplantation. 12. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 7 days before randomization. Prophylactic antibiotics and/or antifungals for neutropenia are allowed. 13. Known positivity for Human Immunodeficiency Virus (HIV), active hepatitis B virus (HBV), or active hepatitis C virus (HCV). Participants without known history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines. 14. Body mass index ≥40 kilograms per square meter (kg/m\^2). 15. Major surgery within 28 days before randomization. 16. History of allergy/anaphylaxis to recombinant proteins, investigational product, or excipients (refer to the current elritercept investigator's brochure for a list of excipients), or ruxolitinib. 17. Any of the following local laboratory abnormalities: 1. Absolute neutrophil count \<500/microliter (μL) (0.5×109/ liter (L)). 2. Platelet count \<50,000/μL (50×109/L) or \>1,000,000/μL (1000×109/L). 3. Blasts \>5% as assessed in peripheral blood at screening or ≥10% in any historical bone marrow assessments. Participants with isolated transient elevations of peripheral blood blasts may be eligible after discussion between the investigator and medical monitor to confirm the blast count is not indicative of disease progression. 4. Serum aspartate aminotransferase or alanine aminotransferase ≥3× the upper limit of normal (ULN). 5. Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin less than (\<) 3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review. 6. Estimated glomerular filtration rate \<30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration equation. 7. Ferritin ≤50 micrograms per liter (μg/L). 8. Folate ≤2.0 nanograms per milliliter (ng/mL). 9. Vitamin B12 ≤200 picograms per milliliter (pg/mL). 18. Ongoing participation in another interventional clinical trial. 19. Participant is unwilling or, in the opinion of the investigator, the participant is unable to comply with the requirements of the protocol. 20. Is a person of childbearing potential but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of elritercept or placebo. 21. Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom, during the entire treatment period until at least 60 days after the last dose of elritercept or placebo. 22. If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire treatment period until at least 60 days after the last dose of elritercept or placebo. 23. For participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.

Conditions

Myelofibrosis Anemia

Locations

Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
Los Angeles Cancer Network — Glendale, California, United States
Cancer and Blood Specialty Clinic — Whittier, California, United States
MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
Advanced Research, LLC — Coral Springs, Florida, United States
Bioresearch Partners — Miami, Florida, United States
AdventHealth - Cancer Institute - Orlando — Orlando, Florida, United States
Florida Clinical Trials Group — Tamarac, Florida, United States
Moffit Cancer Center — Tampa, Florida, United States
Emory University — Atlanta, Georgia, United States
Tufts Medical Center — Boston, Massachusetts, United States
Washington University School of Medicine — St Louis, Missouri, United States
St. Vincent Regional Hospital Cancer Centers — Billings, Montana, United States
University of New Mexico Comprehensive Cancer Center — Albuquerque, New Mexico, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
Duke Blood Cancer Center — Durham, North Carolina, United States
Novant Health — Winston-Salem, North Carolina, United States
Cleveland Clinic — Cleveland, Ohio, United States
Oregon Health and Science University — Portland, Oregon, United States
Thomas Jefferson University — Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Allegheny Health Network Cancer Institute - West Penn Hospital Location — Pittsburgh, Pennsylvania, United States
Medical University of South Carolina — Charleston, South Carolina, United States
Vanderbilt-Ingram Cancer Center (VICC)-Nashville — Nashville, Tennessee, United States
Baylor University Medical Center — Dallas, Texas, United States
MD Anderson Cancer Center — Houston, Texas, United States
The University of Utah-Huntsman Cancer Institute — Houston, Texas, United States
LUMI Research — Houston, Texas, United States
University of Washington — Seattle, Washington, United States
Hospital Universitario Austral — Pilar, Buenos Aires, Argentina
Swiss Medical Center Barrio Parque — Buenos Aires, Ciudad Autonoma de BuenosAires, Argentina
Instituto Medico de la Fundacion Estudios Clinicos — Rosario, Santa Fe Province, Argentina
Hospital Privado de Rosario — Rosario, Santa Fe Province, Argentina
Hospital Aleman (HA) Deutsches Hospital — Buenos Aires, Argentina
BRCR Global — Córdoba, Argentina
Flinders Medical Centre — Bedford Park, Adelaide, SA, Australia
Mid North Coast Cancer Institute (MNCCI) — Coffs Harbour, New South Wales, Australia
Tweed Valley Hospital — Cudgen, New South Wales, Australia
South Eastern Sydney Local Health District — Kogarah, New South Wales, Australia
Medizinische Universitat Wien (Medical University of Vienna - Austria) — Vienna, A, Austria
Medizinische Universitat Innsbruck — Innsbruck, Tyrol, Austria
Klinikum Wels-Grieskirchen — Wels, Upper Austria, Austria
Ordensklinikum Linz Elisabethinen — Linz, Austria
Centre Hospitalier Jolimont-Lobbes — La Louvière, Hainaut, Belgium
UZ Leuven — Leuven, Vlaams-Brabant, Belgium
AZ Delta — Roeselare, West-Vlaanderen, Belgium
Ziekenhuis aan de Stroom-Cadix — Antwerp, Belgium
CHU Namur Site Mont Godinne — Yvoir, Belgium
Centro de Ensino, Pesquisa e Inovacao do Hospital Sao Lucas (CEPIN HSL RJ / Rede Americas) — Rio de Janeiro, Rio de Janeiro, Brazil
Porto Alegre Clinical Hospital (HCPA) — Porto Alegre, Rio Grande do Sul, Brazil
Hospital Mae De Deus - Integrated Oncology Center — Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas da PUCRS — Porto Alegre, Rio Grande do Sul, Brazil
Grupo Elora Pesquisa Clinica — Florianópolis, Santa Catarina, Brazil
Centro de Hematologia e Oncologia (CHO) — Joinville, Santa Catarina, Brazil
Hospital Amaral Carvalho (HAC) — Jaú, São Paulo, Brazil
Portuguese Charity of Sao Paulo — São Paulo, Brazil
UMHAT 'Dr. Georgi Stranski', EAD — Pleven, Bulgaria
Dr. Pencho Georgiev - Outpatient Center — Plovdiv, Bulgaria
UMHAT Sv. Ivan Rilski — Sofia, Bulgaria
Specialized Hospital for Active Treatment of Haematological Diseases - Sofia — Sofia, Bulgaria
Juravinski Cancer Centre — Hamilton, Ontario, Canada
Princess Margaret Cancer Centre — Toronto, Ontario, Canada
Jewish General Hospital — Montreal, Quebec, Canada
McGill University Health Center — Montreal, Quebec, Canada
Hospital Cliniico Regional de Concepcion Dr — Concepción, Biobio, Chile
IC La Serena Research — La Serena, Coquimbo Region, Chile
Icegclinic — Santiago, La Florida, Chile
Immunocel — Las Condes, Santiago Metropolitan, Chile
Centro de Oncologia de Precision — Santiago, Santiago Metropolitan, Chile
Hospital Pablo Tobon Uribe — Medellín, Antioquia, Colombia
Clinica General del Norte De Barranquilla — Barranquilla, Atlántico, Colombia
Los Cobos Medical Center — Bogotá, Bogota D.C., Colombia
Funcacion santa Fe De Bogota — Bogota, Cundinamarca, Colombia
Masaryk University Hospital Brno, Department of Internal Medicine, Hematology and Oncology — Brno, Czech Republic, Czechia
Fakultni nemocnice Hradec Kralove — Hradec Králové, CZ, Czechia
Vseobecna fakultni nemocnice Praha — Prague, CZ, Czechia
Fakultni nemocnice Kralovske Vinohrady — Prague, Czechia
CHU de Nice — Nice, Alpes Maritimes, France
Centre Hospitalier Lyon Sud — Pierre-Bénite, Auvergne-Rhône-Alpes, France
CHU de Strasbourg — Strasbourg, Bas Rhin, France
Institut Paoli Calmettes — Marseille, Bouches-du-Rhone, France
Centre Hospitalier Regional Universitaire Brest Hopital Morvan — Brest, Finistere, France
CHU de Bordeaux — Pessac, Gironde, France
Centre Hospitalier Regional Universitaire de Lille — Lille, Nord, France
Assistance Publique Hopitaux de Paris — Paris, Paris, France
CHU de Poitiers — Poitiers, Vienne, France
Universitaetsklinikum Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitaetsklinikum Heidelberg (UKHD) — Heidelberg, Baden-Wurttemberg, Germany
Kliniken Ostalb — Mutlangen, Baden-Wurttemberg, Germany
Muehlenkreiskliniken AoeR-Johannes Wesling Klinikum Minden - Universitaetsklinik fuer Neurologie und Neurogeriatrie — Minden, North Rhine-Westphalia, Germany
Institut fur Versorgungsforschung in der Onkologie GbR — Koblenz, Rhineland-Palatinate, Germany
Klinikum Chemnitz GmbH — Chemnitz, Saxony, Germany
University Hospital Halle (Saale) — Halle, Saxony-Anhalt, Germany
Universitaetsklinikum Jena — Jena, Thuringia, Germany
Praxis am Volkspark — Berlin, Germany
Olympion General Clinic & Rehabilitation Center — Pátrai, Ahaia, Greece
Laiko General Hospital of Athens — Athens, Attica, Greece
General Hospital — Athens, Attica, Greece
Alexandra General Hospital of Athens — Athens, Attica, Greece
University of Crete — Heraklion, Crete, Greece
Ippokrateion Hospital of Thessaloniki — Thessaloniki, Macedonia, Greece
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika — Debrecen, HB, Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz — Tatabánya, Komarom-Esztergom VArmegye, Hungary
Medanta- The Medicity- Gurugram — Gurgaon, Haryana, India
Amrita Institute of Medical Sciences — Kochi, Kerala, India
Regional cancer Centre — Thiruvananthapuram, Kerala, India
Sahyadri Super Speciality Hospital Deccan — Pune, Maharashtra, India
All India Institute of Medical Science — New Delhi, National Capital Territory of Delhi, India
Rajiv Gandhi Cancer Institute and Research Centre — Rohini, NEW Delhi, India
Apollo Specialty Hospitals — Chennai, Tamil Nadu, India
Apollo Hospital Hyderabad — Hyderabad, Telangana, India
Tata Medical Center, Kolkata — Kolkata, West Bengal, India
Max Super Specialty Hospital — Delhi, India
Cork University Hospital — Cork, Ireland
St James's Hospital — Dublin, Ireland
Mater Misericordiae University Hospital — Dublin, Ireland
University Hospital Galway — Galway, Ireland
Rambam Health Care Campus — Haifa, North, Israel
The Tel Aviv Sourasky Medical Center — Tel Aviv, TLV, Israel
Carmel Medical Center — Haifa, Israel
Hadassah Medical Organization, Hadassah Medical Center, Ein- — Jerusalem, Israel
Rabin Medical Center — Petah Tikva, Israel
IRCCS - AOU di Bologna - Sant Orsola Malpighi — Bologna, BO, Italy
Universitaria di Ferrara Azienda Ospedaliero — Cona, Ferrara, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l — Meldola, Forli-Cesena, Italy
Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma — Rome, Lazio, Italy
Ospedale S Eugenio — Rome, Lazio, Italy
Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano — Milan, MI, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, RM, Italy
Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica — Ancona, Italy
Policlinico Universitario di Catania — Catania, Italy
Azienda Ospedaliera Universitaria Careggi — Florence, Italy
AOU Citta della Salute e della Scienza di Torino — Torino, Italy
Azienda Sanitaria Universitaria Friuli Centrale — Udine, Italy
Chiba Cancer Center — Chiba, Chiba, Japan
Ehime University Hospital — Toon-shi, Ehime, Japan
Kobe City Medical Center General Hospital — Kobe, Hyōgo, Japan
Hitachi General Hospital — Hitachi, Ibaraki, Japan
Mie University Hospital — Tsu, Mie-ken, Japan
University of Miyazaki Hospital — Miyazaki, Miyazaki, Japan
Tokyo Metropolitan Komagome Hospital — Bunkyo-Ku, Tokyo, Japan
University of Yamanashi Hospital — Chuo-shi, Yamanashi, Japan
University Malaya Medical Centre — Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Pulau Pinang — George Town, Pulau Pinang, Malaysia
Hospital Queen Elizabeth — Kota Kinabalu, Sabah, Malaysia
Hospital Ampang — Ampang, Selangor, Malaysia
Hematologica Alta Especialidad S.C. — Huixquilucan, Mexico de Mexico, Mexico
Universidad Autonoma de Nuevo Leon — Monterrey, Mexic, Mexico
OSMO - Oaxaca Site Management Organization S.C — Oaxaca City, Oaxaca, Mexico
Pratia Poznan — Poznan, Greater Poland Voivodeship, Poland
Wojewodzki Szpital Zespolony Im L Rydygiera — Torun, Kuyavian-Pomeranian Voivodeship, Poland
MTZ Clinical Research Powered by PRATIA — Warsaw, Masovian Voivodeship, Poland
Zespol Szpitali Miejskich w Chorzowie — Chorzów, Silesian Voivodeship, Poland
Pratia Oncology Katowice — Katowice, Silesian Voivodeship, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Hematologii — Lodz, Łódź Voivodeship, Poland
Institutul Oncologic Prof. Dr. Ion Chiricuta — Cluj-Napoca, CJ, Romania
Spitalul Municipal Filantropia Craiova — Craiova, Dolj, Romania
Colentina Clinical Hospital — Bucharest, Romania
Spitalul Clinic Municipal de Urgenta Timisoara — Timișoara, Romania
King Faisal Specialist Hospital & Research Centre Riyadh — Riyadh, Saudi Arabia
King Khalid University Hospital — Riyadh, Saudi Arabia
Samsung Medical Center — Seoul, Gangnam-gu, South Korea
Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea
Korea University Anam Hospital — Seoul, Seongbuk-gu, South Korea
Soon Chun Hyang University Hospital Seoul — Seoul, Seoul Teugbyeolsi, South Korea
Daegu Catholic University Medical Center — Daegu, South Korea
The Catholic University of Korea — Seoul, South Korea
Seoul National University Hospital — Seoul, South Korea
Institut Catala d'Oncologia — Badalona, Barcelona, Spain
Institut Catala d'Oncologia Hospital Duran y Renals — L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de Gran Canaria Doctor Negrin — Las Palmas de Gran Canaria, LAS Palmas, Spain
Hospital Universitario Virgen de la Victoria — Málaga, M, Spain
Hospital Universitari Vall d'Hebron — Barcelona, Spain
Hospital Ramon Y Cajal — Madrid, Spain
Universidad de Salamanca - Hospital Universitario de Salamanca — Salamanca, Spain
Hospital Universitari i Politecnic La Fe — Valencia, Spain
Orebro University Hospital — Örebro, Sweden
Karolinska University Hospital — Stockholm, Sweden
Taipei Veterans General Hospital — Taipei, Beitou, Taiwan
National Taiwan University Hospital — Taipei, Taiwan (r.o.c.), Taiwan
Kaohsiung Medical University Hospital — Kaohsiung City, Taiwan
Taichung Veterans General Hospital — Taichung, Taiwan
National Cheng Kung University Hospital — Tainan, Taiwan
Ankara Bilkent City Hospital — Çankaya, Ankara, Turkey (Türkiye)
VM Medical Park Mersin Hospital — Mersin, Mezitli, Turkey (Türkiye)
Istanbul University-CerrahpaAYa, CerrahpaAYa Faculty of Medicine — Istanbul, Turkey (Türkiye)
Istanbul Florence Nightingale Hospital — Istanbul, Turkey (Türkiye)
United Lincolnshire Teaching Hospitals NHS Trust — Lincoln, East Midlands, United Kingdom
University Hospital of Leicester NHS — Leicester, Leicestershire, United Kingdom
Imperial College Healthcare NHS Trust — London, London, City of, United Kingdom
Sunderland and South Tyneside NHS Foundation Trust — Sunderland, Tyne and Wear, United Kingdom
Birmingham Heartlands Hospital — Birmingham, W Mids, United Kingdom
UCL Cancer Institute - University College London Hospitals NHS Foundation Trust — London, United Kingdom
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital — London, United Kingdom

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