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

RecruitingPhase 3Ages 18 Years - anyAllTakeda
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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. Hi
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What it tests

  • Placebo
  • Elritercept
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Where

195 sites
Banner MD Anderson Cancer Center
Gilbert, United States
Los Angeles Cancer Network
Glendale, United States
Cancer and Blood Specialty Clinic
Whittier, United States
MedStar Georgetown University Hospital
Washington D.C., United States
Advanced Research, LLC
Coral Springs, United States
Bioresearch Partners
Miami, United States
AdventHealth - Cancer Institute - Orlando
Orlando, United States
Florida Clinical Trials Group
Tamarac, United States

…and 187 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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