drugset / Trial / NCT07422480
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
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-05-21
- Primary completion
- 2029-04-30
- Completion
- 2033-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elritercept | Protein / enzyme biologic | 3.75 mg/kg | Subcutaneous |
| Subject | Elritercept | Protein / enzyme biologic | 5 mg/kg | Subcutaneous |
| Comparator | epoetin alfa | Protein / enzyme biologic | 450 iu/kg | Subcutaneous |
| Comparator | epoetin alfa | Protein / enzyme biologic | 1050 iu/kg | Subcutaneous |