Clinical Trial Details
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Phase IIIInterventional
A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions
Protocol: 2026P000334
Overview
Primary Objective:
- To evaluate the efficacy of elritercept on red blood cell transfusion independence (RBC-TI) for a minimum 12- week period within 24 weeks with concurrent mean hemoglobin (Hgb) increase ?1.5 g/dL compared to epoetin alfa.
Secondary Objectives:
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To compare the effect of elritercept on RBC-TI for a minimum 16-week period within 24 weeks versus epoetin alfa.
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To compare effect of elritercept on RBC-TI for a minimum 12-week period within 24 weeks versus epoetin alfa.
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To compare the effect of elritercept on RBC-TI for a minimum 24-week period within 24 weeks versus epoetin alfa.
Investigators
Location
Winship Cancer Institute