RENEW

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)

What's the purpose of the trial?

This study (KER-050-D301) is evaluating the efficacy and safety of elritercept (KER-050) versus placebo in adult participants with transfusion-dependent anemia with very low, low, or intermediate risk MDS, or more recently defined as myelodysplastic neoplasms, with or without ring sideroblasts. The study is divided into the Screening Period, Double-blind Treatment Period, Safety Follow-Up Period and Long-term Follow-up Period. Approximately 255 participants will be enrolled, randomized 2:1 to receive either elritercept or placebo.
Trial status

Accepting patients

Phase
Phase 3
Enrollment
225
Last Updated
1 day ago
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Experimental Treatments

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  • Elritercept is an investigational bone marrow stimulating medication being studied for use in myelodysplastic syndrome (MDS).
  • Placebo is a substance that has no therapeutic effect and can be used as a control in testing new drugs in clinical trials.

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Accepting patients

KER-050

Accepting patients

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