What is elritercept studying for anemia in myelodysplastic syndromes?

Elritercept is being studied to see how well it reduces the need for red blood cell transfusions and improves tiredness and quality of life in adults with anemia caused by certain risks of myelodysplastic syndromes. This research compares elritercept to epoetin alfa and is sponsored by Takeda. Participants will help researchers understand how these treatments work and their safety profiles.

Who may be eligible for this anemia clinical trial?

Adults aged 18 years or older with very low, low, or intermediate risk myelodysplastic syndromes who need regular red blood cell transfusions may be eligible. Both males and females can participate. Important factors include not having received certain treatments recently and agreeing to use contraception if applicable. Please review eligibility criteria for more details.

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

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07422480

A Phase 3 Randomized Trial Comparing Elritercept and Epoetin Alfa for Treating Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes Who Need Red Blood Cell Transfusions

Led by Takeda · Updated on 2026-03-09

300

Participants Needed

146

Research Sites

230 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating elritercept compared to epoetin alfa to treat anemia in adults with very low, low, or intermediate risk myelodysplastic syndromes MDS who need regular red blood cell RBC transfusions. The study aims to assess how elritercept affects the need for RBC transfusions, its safety, and whether it improves tiredness and quality of life compared to epoetin alfa. The trial also explores the immune response to elritercept and monitors medical problems related to the treatment. Participants will be randomly assigned to receive either elritercept or epoetin alfa. Those receiving elritercept will start with a dose of 3.75 mgkg by subcutaneous injection every 4 weeks, which may be increased to 5.0 mgkg if necessary. Participants receiving epoetin alfa will start at 450 IUkg by subcutaneous injection once weekly, with possible dose escalation up to 1050 IUkg. Treatment will continue with monitoring over several cycles, each lasting 28 days, with assessments up to 48 weeks and potential follow-up to about 5 years. During the study, participants will have regular visits to assess their need for RBC transfusions, hemoglobin levels, fatigue using the FACIT-Fatigue Scale, quality of life through questionnaires, and blood tests to monitor drug levels and immune response. The main outcome is the proportion of participants who become independent of RBC transfusions for at least 12 consecutive weeks with improved hemoglobin. Safety and overall health will be closely monitored, including tracking any progression to acute myeloid leukemia or death. The total participation duration may last up to several years to evaluate long-term effects.

CONDITIONS

Brief Title

A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male or female participants aged 18 years or older
Able to understand and voluntarily sign informed consent
Diagnosed with very low, low, or intermediate risk myelodysplastic syndromes (MDS) confirmed by central review
Bone marrow blast count less than 5% at screening
Endogenous serum erythropoietin level below 500 U/L
Requires 2 to 6 red blood cell transfusions every 8 weeks for at least 8 weeks before randomization
Hemoglobin less than 11.0 g/dL after last transfusion
Eastern Cooperative Oncology Group score of 0, 1, or 2

You will not qualify if you...

Prior therapy with epoetin alfa (more than 2 doses within 8 weeks), darbepoetin, certain growth factors, immunomodulatory drugs, hypomethylating agents, luspatercept, sotatercept, imetelstat, elritercept, immunosuppressive therapy, or hematopoietic cell transplant
Myelodysplastic syndromes with del(5q) cytogenetic abnormality, unclassifiable MDS, or secondary MDS
History of acute myeloid leukemia
Anemia from other known causes such as nutritional deficiencies or hemolytic anemia
Significant cardiovascular disease or low heart function
History of recent thromboembolic events
Uncontrolled high blood pressure
Recent malignancies other than MDS unless treated and stable
History of organ or bone marrow transplantation
Active infection requiring recent antibiotic treatment
Known positive for HIV, active hepatitis B or C infection
Body mass index 40 or higher
Major surgery within 28 days prior to randomization
Recent seizures or poorly controlled seizures
Allergy to study drugs or related proteins
History of pure red cell aplasia or antibodies against erythropoietin
Certain abnormal laboratory test results
Participation in another interventional clinical trial
Unwillingness or inability to comply with the study protocol
Not agreeing to use effective contraception if of childbearing potential
Special legal or social status for participants in France

Research Team

Takeda Contact

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