Elritercept for Anemia in Myelodysplastic Syndromes (MDS)
This study is testing a drug called elritercept to see if it can help adults with certain types of myelodysplastic syndromes (MDS) who need regular blood transfusions for anemia. MDS is a condition where your bone marrow doesn't make enough healthy blood cells. The main goal is to find out if elritercept can reduce your need for red blood cell transfusions over 24 weeks. The study will also look at how safe elritercept is and how well people tolerate it. You might receive elritercept or a placebo (an inactive substance) every four weeks. The study is looking for 225 participants aged 18 and older.
- Study design
- This is a Phase 3, randomized, double-blind study where participants will be randomly assigned to receive either elritercept or a placebo. Approximately 225 participants are planned for this study.
- What's involved
- You would receive injections every 4 weeks for at least 48 weeks. Study visits will occur about every 2 weeks for the first 6 cycles, then every 4 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal is measured through Week 24, and the double-blind treatment period lasts for 48 weeks.
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NCT06499285
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
Recruiting
PHASE3Ages 18+InterventionalTreatmentTakeda
~225 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:ElriterceptPlacebo
At a glance
Recruiting sites
138 of 177 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Achieving Transfusion Independence (TI) for ≥8 Weeks
Measured over Baseline through Week 24
Conditions
Where it's being run
177 sites across 82 statesUnited Kingdom8
Italy7
Turkey (Türkiye)7
Ireland6
South Korea6
Bulgaria5
Czechia5
Hungary5
Study leadership
- Study Director · STUDY_DIRECTOR · Takeda
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information and/or protected personal data in accordance with national and local study participant data protections and privacy regulations.
Male or female greater than or equal to (≥)18 years of age at the time of signing informed consent.
Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow aspirate, read by an independent central reader to confirm diagnosis at Screening) according to the World Health Organization 2016 classification that meets the International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease.
Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either:
Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to respond to ESA treatment, defined as follows:
Less than 5% blasts in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader.
Eastern Cooperative Oncology Group performance status of 0 to 2.
Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception.
In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the protocol (e.g., all study procedures, return for follow-up visits).
Exclusion
Del(5q) MDS or therapy-related (secondary) MDS.
Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and/or folate).
Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization.
Clinically significant cardiovascular disease defined as:
Known ejection fraction \<35%, confirmed by a local echocardiogram performed during Screening, or a previously performed echocardiogram if collected within 6 months before Screening.
Child-Pugh class C hepatic impairment.
Stroke, deep vein thrombosis, or pulmonary embolism within 6 months before Screening.
Any known history of acute myeloid leukemia (AML).
Prior history of malignancies, other than MDS, unless participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for ≥ 5 years. However, participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:
History of solid organ or bone marrow transplantation.
Active infection requiring intravenous treatment (e.g., antibiotics, antifungals, or antivirals) within 28 days, or oral treatment within 14 days before randomization.
History of or known active chronic infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.
Body mass index ≥ 40 kilograms per meter square (kg/m\^2).
Major surgery within 28 days before randomization.
History of allergy/anaphylaxis to investigational medicinal product (IMP) excipients (refer to the current elritercept IB for a list of excipients) or recombinant proteins.
Prior use of elritercept, luspatercept, or sotatercept.
Prior use of hypomethylating agents (HMAs), isocitrate dehydrogenase inhibitor, lenalidomide, imetelstat, or immunosuppressive therapy given for treatment of MDS.
Iron chelation therapy initiated within 8 weeks before randomization. Participants on stable doses of iron chelation therapy for ≥ 8 weeks are allowed.
Vitamin B12 or folate therapy initiated within 4 weeks before randomization. Participants on stable replacement doses for ≥ 4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.
Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥ 8 weeks are allowed.
High-dose corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone lesser than or equal to (≤) 10 mg/day or corticosteroid equivalent for ≥ 4 weeks are allowed.10 mg/day or corticosteroid equivalent for ≥ 4 weeks are allowed.
Treatment with any investigational drug within 28 days before Screening or, if the half-life of the product is known, within 5 times the half-life before Screening, whichever is longer.
Ongoing participation in another interventional clinical study.
Serum EPO level \>500 U/L.
Platelet count ≥450 × 10\^9/L or ≤25 × 10\^9/L.
Absolute neutrophil count ≤ 500/µL.
Serum aspartate aminotransferase or alanine aminotransferase ≥3 × the upper limit of normal (ULN).
Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome.
Ferritin ≤ 50 micrograms per litre (μg/L).
Folate ≤2.0 nanograms per milliliter (ng/mL).
Vitamin B12 ≤200 picograms per milliliter (pg/mL).
Estimated glomerular filtration rate \<30 milliliters per minute per 1.73 meter square (mL/min/1.73m\^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Collaboration equation.
Pregnant or lactating female.
Any other condition not specifically noted above that, in the opinion of the Investigator, would preclude the participant from participating in the study or could confound interpretation of data from the study.
Investigational site staff members directly involved in the conduct of the study and site staff members otherwise supervised by the Investigator, employees of the Sponsor or contract research organization (CRO) directly involved in the conduct of the study, or immediate family members (defined as a spouse, parent, child, or sibling, whether biological or legally adopted).
For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults (per applicable French law \[Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1\]).
What this trial measures
- Percentage of Participants Achieving Transfusion Independence (TI) for ≥8 WeeksBaseline through Week 24
Transfusion independence is defined as the absence of any red blood cells (RBC) transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24.