A Study of Elritercept for Anemia in Myelodysplastic Syndromes (MDS)

This study is testing a drug called elritercept to treat anemia (low red blood cell count) in adults with certain types of myelodysplastic syndromes (MDS). MDS is a group of conditions where the bone marrow doesn't make enough healthy blood cells. Researchers want to understand how safe elritercept is and how well people tolerate different doses. They will also look at how elritercept affects anemia and the production of healthy red blood cells. Elritercept works by helping to increase red blood cell production. The study aims to enroll 160 participants. The current status of the study is unclear.

Study design: This is an interventional study with a planned enrollment of 160 participants. The phase of the study is not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for treatment-emergent adverse events and serious adverse events from the start of treatment up to 11.2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)

Recruiting

PHASE2Ages 18+InterventionalTreatment

Takeda

~160 participants

Updated 2026-08-21 on ClinicalTrials.gov

What's tested:Elritercept

At a glance

Recruiting sites

35 of 53 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Measured over From treatment initiation to end of study (up to 11.2 years)

Conditions

Myelodysplastic Syndromes

Cytopenia

Where it's being run

53 sites across 20 states

Germany11

France7

Victoria6

Spain6

New South Wales3

Czechia3

Florida2

South Australia2

Study leadership

Study Director · STUDY_DIRECTOR · Takeda

Who to contact

Takeda Contact

[email protected]

+1-877-825-3327

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.

ring sideroblast (RS)-positive as defined by WHO 2016 criteria.

Requiring at least 2 units of RBC transfusions in the preceding 8 weeks before cycle 1 day 1 (C1D1). 2. Cohort B:

Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.

Non-RS as defined by WHO 2016 criteria.

Requiring at least 2 units of RBC transfusions in the 8 weeks before C1D1. 3. Cohort C:

Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.

Has anemia, defined by Hgb ≤ 10 g/dL during the Pretreatment Period, and received no RBC transfusion in the 8 weeks before C1D1. 4. Cohort D:

Diagnosis of CMML according to WHO classification.

Has anemia, defined by Hgb ≤ 10 g/dL during the Pretreatment Period, and received no RBC transfusion in the 8 weeks before C1D1.

OR

Received at least 2 units of RBC transfusions for anemia in the 8 weeks before C1D1. 5. Cohort E:

Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.

Requiring ≥ 2 units of RBC transfusions in the preceding 8 weeks before C1D1.

Receipt of ≥ 20 units of RBC in transfusion over the participant's lifetime.

Serum ferritin \> 1000 nanograms per milliliter (ng/mL) on ≥ 2 assessments in the preceding 8 weeks before C1D1.

Treated with stable dose of iron chelation therapy for ≥ 8 weeks prior to C1D1. 6. Cohort F:

Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.

Requiring ≥ 2 units of RBC transfusions in the preceding 8 weeks before C1D1.

Receipt of ≥ 20 units of RBC in transfusion over the participant's lifetime.

Serum ferritin \> 1000 ng/mL on ≥ 2 assessments in the preceding 8 weeks before C1D1.

Not treated with iron chelation therapy in the preceding 8 weeks before C1D1 and not eligible to initiate iron chelation therapy in the opinion of the Investigator and in accordance with local treatment guidelines for initiation of iron chelation therapy. 7. Cohort G:

Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.

RS-positive as defined by WHO 2016 criteria OR non-RS as defined by WHO 2016 criteria.

Relapsed, refractory, or intolerant to frontline luspatercept treatment and have not received an interceding therapy (for example, erythropoiesis-stimulating agent \[ESA\])

Relapsed is defined as documentation of response to luspatercept therapy and subsequent development of a need for transfusion(s).

Refractory is defined as documentation of no response with luspatercept ≥ 1 mg/kg administered for ≥ 12 weeks duration.

Intolerant is defined as documentation of discontinuation of luspatercept therapy due to intolerance or an AE at any time after introduction.

Requiring ≥ 2 units of RBC transfusions over 8 weeks prior to C1D1.

Erythropoietin (EPO) \< 500 international units per liter (U/L) at Baseline.

Last dose of luspatercept is ≥ 3 weeks and \< 12 months from C1D1. 8. \< 5% blasts in bone marrow assessed by bone marrow aspirate during the Pretreatment Period.

What this trial measures

Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)From treatment initiation to end of study (up to 11.2 years)
An AE is defined as any untoward medical occurrence, in a clinical study participant administered a medicinal product, that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that, at any dose: results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.