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Compares treatment options for Myelofibrosis
Official title A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
ClinicalTrials.gov ID: NCT07623161
What this study is testing
What is Elritercept?
Elritercept is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for myelofibrosis.
Also referred to as TAK-226.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Transfusion status as assessed in the 12 weeks immediately preceding randomization classified as Transfusion Dependent: 3 to 8 RBC units over 12...
- 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...
You likely can't join 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...
See the full eligibility criteria
Who can 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)...
- 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...
- Eastern Cooperative Oncology Group score less than or equal to (≤) 2.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 \ 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...
- 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...
- 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 treatment 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...
- 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...
- For participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, California, United States
- Whittier, California, United States
- Washington D.C., District of Columbia, United States
- Coral Springs, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tamarac, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Billings, Montana, United States
- Albuquerque, New Mexico, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
+ 169 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, California, United States; Whittier, California, United States; Washington D.C., District of Columbia, United States; Coral Springs, Florida, United States; Miami, Florida, United States; Orlando, Florida, United States and 183 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.