A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low,
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 epoeti
| Condition(s) | Myelodysplastic Syndrome, Anemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria 1. Male or female participants aged ≥ 18 years or older at time of signing the informed consent form (ICF). 2. 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. 3. 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 grea |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Takeda |
| Locations | Orange, California, United States; Tamarac, Florida, United States; Atlanta, Georgia, United States; Skokie, Illinois, United States; Louisville, Kentucky, United States; Kansas City, Missouri, United States (+140 more sites) |
| Start date | 2026-04-01 |
| NCT ID | NCT07422480 |
| Official listing | https://clinicaltrials.gov/study/NCT07422480 |