Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT05181592
Brief 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)
Detailed 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:
NCT05181592
Study Brief:
Protocol Section:
NCT05181592