What is elritercept studying for myelofibrosis?

Elritercept is being studied to see if it improves anemia and related symptoms in adults with myelofibrosis who are taking ruxolitinib. The trial compares elritercept to a placebo to understand its effects on fatigue, physical activity, spleen size, bone marrow, and safety. This research is sponsored by Takeda.

Who may be eligible for this myelofibrosis clinical trial?

Adults aged 18 years or older diagnosed with primary or post-essential thrombocythemia/polycythemia vera myelofibrosis may be eligible. Participants must be dependent on red blood cell transfusions and taking a stable dose of ruxolitinib. They should have a good overall health status and no recent serious heart or blood clot issues. Please review eligibility criteria for more details.

Is there any cost to participate in this myelofibrosis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07623161

Phase 3 Study Comparing Elritercept to Placebo for Adults with Myelofibrosis and Anemia Taking Ruxolitinib

Led by Takeda · Updated on 2026-08-05

324

Participants Needed

194

Research Sites

224 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating how well elritercept works to improve anemia in adults with myelofibrosis MF who are already taking ruxolitinib. The study compares elritercept to a placebo and aims to see if elritercept can reduce tiredness, improve MF-related symptoms, and help participants perform physical activities more easily. It also looks at elritercepts effects on bone marrow, spleen size, antibody development, and long-term safety. Participants receive either elritercept or a placebo by subcutaneous injection once every 4 weeks during a 36-week double-blinded treatment period. The starting dose of elritercept is 3.75 mgkg, with a possible increase to 5.0 mgkg after the second cycle based on response and safety. After 36 weeks, participants who took placebo may switch to receive elritercept in an extended open-label phase. During the study, participants undergo assessments including blood transfusion independence, symptom and fatigue questionnaires, spleen imaging, and bone marrow evaluation. Researchers monitor safety, antibody formation, and survival for up to 7 years. The main outcome is the proportion of participants who become independent from red blood cell transfusions for at least 12 consecutive weeks during the 36-week treatment. Participants are involved in regular visits and evaluations throughout the treatment and follow-up periods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Aged 18 years or older at the time of signing consent
Able to understand the trial purpose and risks and provide consent
Diagnosed with primary myelofibrosis, post-essential thrombocythemia MF, or post-polycythemia vera MF as confirmed by pathology
Dependent on 3 to 8 red blood cell transfusions over the 12 weeks before randomization
Receiving ruxolitinib as standard care for at least 12 weeks with a stable daily dose for at least 8 weeks prior to randomization
Eastern Cooperative Oncology Group (ECOG) score of 2 or less

You will not qualify if you...

Prior treatment with luspatercept, sotatercept, or similar transforming growth factor beta inhibitors
Systemic treatment within 28 days before randomization with androgens (except stable doses for hypogonadism), erythropoiesis-stimulating agents, colony stimulating factors, high dose corticosteroids (except stable low doses), hydroxyurea, immunomodulatory drugs, interferon, thrombopoietin receptor agonists, or investigational drugs
New or adjusted iron chelation therapy within 8 weeks before randomization
Anemia caused by conditions other than MF or JAK inhibitor therapy
Red blood cell transfusions within 12 weeks before randomization for reasons other than MF
Life expectancy less than 12 months
Significant cardiovascular disease or uncontrolled hypertension
Recent thromboembolic events within 6 months
History of malignancies other than MF unless disease-free for 2 years
History of organ or bone marrow transplant
Active infection requiring recent antibiotics
Known HIV, active hepatitis B or C infection
Body mass index of 40 kg/m2 or higher
Major surgery within 28 days before randomization
Allergy to recombinant proteins, investigational product, or ruxolitinib
Several specified laboratory abnormalities including low neutrophils or platelets, elevated liver enzymes, or low vitamin levels
Participation in another interventional trial
Inability or unwillingness to comply with protocol
Persons of childbearing potential not agreeing to effective contraception
Pregnant or breastfeeding participants not agreeing to forego breastfeeding
Specific legal or social protections for participants in France

Research Team

Takeda Contact

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