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Clinical Trial Summary

A phase IIIb, open-label, single arm study to evaluate the efficacy and safety of luspatercept in patients with lower-risk MDS and ring-sideroblastic phenotype (MDS-RS)

Clinical Trial Description

This is a phase IIIb, single arm, multicenter study to further explore the efficacy and safety of luspatercept in subjects with anemia due to IPSS-R very low-, low-, or intermediate-risk MDS with RS who require RBC transfusions. The study will consist of a screening period, a treatment period (primary phase and extension phase), and a posttreatment follow-up period. The study will involve study sites in Germany, France, Austria and Switzerland. It is planned to include 70 patients to receive treatment with luspatercept to end up with 64 evaluable subjects. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05181592
Study type Interventional
Source GWT-TUD GmbH
Contact Martin Puttrich
Phone 0049 351 25933 193
Email [email protected]
Status Recruiting
Phase Phase 3
Start date October 27, 2021
Completion date June 30, 2025

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