A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes
Status:
Completed
Trial end date:
2020-11-26
Target enrollment:
Participant gender:
Summary
The study will be conducted in compliance with the International Council on Harmonisation
(ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good
Clinical Practice (GCP) and applicable regulatory requirements.
This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to
determine the efficacy and safety of luspatercept (ACE-536) versus placebo in participants
with anemia due to the Revised International Prognostic Scoring System (IPSS-R) very low,
low, or intermediate MDS with ring sideroblasts who require red blood cell (RBC)
transfusions.