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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Myelofibrosis, Anemia

In brief

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.

Key facts

Study ID

NCT07623161

Run by

Takeda

People needed

324

Starts

2026-08-25

Expected to finish

2034-03-30

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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

Where it is running

• LUMI Research — Houston, Texas, United States (enrolling)
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Novant Health — Winston-Salem, North Carolina, 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
• Advanced Research, LLC — Coral Springs, Florida, 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
• Next Innovative Clinical Research — Baytown, Texas, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Cancer and Blood Specialty Clinic — Whittier, California, United States

Full record on ClinicalTrials.gov

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