A Study to Evaluate the Efficacy, Pharmacokinetics and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) in Chinese and Japanese Subjects With Ring Siderobl

• Status: Recruiting
• Trial end date: 2026-02-23

Summary

This is a Phase 2, multicenter, single-arm bridging study to evaluate the efficacy, pharmacokinetics, and safety of luspatercept (ACE-536) for the treatment of anemia due to IPSSR very low, low, or intermediate risk myelodysplastic syndromes (MDS) in Chinese and Japanese subjects with ring sideroblasts who require RBC transfusions. The study is divided into the Screening Period, Treatment Period (Primary Phase and Extension Phase) and a Posttreatment Follow-up Period and will enroll a total of 30 subjects.

• Phase: Phase 2

Details

• Lead Sponsor: Celgene
• Treatments: Luspatercept