The main aim of this study is to assess how elritercept works in lowering the need for RBC (red blood cell) transfusions and how safe elritercept is when compared with epoetin alfa. Other aims are to learn if elritercept improves tiredness as reported by participants without needing RBC transfusion compared with epoetin alfa, the RBC transfusion burden and quality of life compared with epoetin alfa. The study also aims to find out the extent of the immune response to elritercept. The study will also check on the medical problems (safety) of elritercept.
Male or female participants aged ≥ 18 years or older at time of signing the informed consent form (ICF).
Able to understand the purpose and risks of the trial and voluntarily sign an ICF prior to any trial-related procedures being conducted and authorization to use protected health information and personal data in accordance to national and local privacy regulations.
Documented diagnosis of myelodysplastic syndrome(s) (MDS) according to WHO 2016 classification that meets International Prognostic Scoring System - Revised (IPSS-R) classification of very low-, low-, or intermediate-risk disease, confirmed by central laboratory independent reviewer prior to randomization. Hemoglobin (Hgb), platelet, and absolute neutrophil count (ANC) values should be collected greater than (>) 14 days after red blood cell (RBC) transfusion or greater than (>) 7 days after platelet transfusion, unless otherwise considered to be pretransfusion values.
Bone marrow less than (<) 5% blasts in an evaluable bone marrow collected at screening and confirmed by central pathology independent reviewer.
Epoetin alfa
Darbepoetin
Granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor administered ≤8 weeks (56 days) prior to randomization unless given for treatment of febrile neutropenia.
Immunomodulatory drug (IMiDs) including lenalidomide
Parallel
Elritercept
DrugElritercept, SC, injection.
Epoetin Alfa
DrugEpoetin Alfa SC injection.
Proportion of Participants who are RBC Transfusion Independent (RBC-TI) for any Consecutive Greater Than Equal to (≥) 12-Week Period From Day 1 Through 24 Weeks With Concurrent Mean Hemoglobin (Hgb) Increase ≥ 1.5 Grams per Deciliter (g/dL) From Baseline
RBC-TI is defined as no red blood cell (RBC) transfusions administered for the specified time period during study treatment.
Proportion of Participants who are RBC-TI for any Consecutive ≥16-Week Period From Day 1 to 24 Weeks
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
Proportion of Participants who are RBC-TI for any Consecutive ≥12-Week Period From Day 1 to 24 Weeks
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
Proportion of Participants who are RBC-TI for a Consecutive 24-Week Period From Day 1
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
Proportion of Participants who Have Confirmed Meaningful Improvement or no Meaningful Deterioration in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score With no RBC Transfusions Between Week 12 to Week 24
The FACT-An questionnaire is used to assess the effects of disease symptoms on functioning and well-being in participants with anemia. The FACT-An Anemia scale includes 13 fatigue-specific items (which together comprise the FACIT-Fatigue scale).
