NCT04419649

A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)

A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to learn how safe elritercept is and how well adults with anemia associated with lower-risk MDS tolerate treatment with different doses of elritercept. Other aims are to learn how safe elritercept is by looking at how many participants have MDS that worsens during the study and learn about the effects of elritercept on anemia linked to MDS. The study will also look to learn how elritercept affects the production of healthy RBCs.

Detailed description

Elritercept (KER-050) is a recombinant fusion protein being studied to increase red blood cell production by inhibiting the signaling of a subset of the transforming growth factor beta (TGF-ß) family of proteins.

Conditions

• Myelodysplastic Syndromes
• Cytopenia

Interventions

Type	Name	Description
DRUG	Elritercept	Elritercept SC injection.

Timeline

• Start date: 2020-08-19
• Primary completion: 2029-10-30
• Completion: 2031-10-30
• First posted: 2020-06-05
• Last updated: 2026-02-06

Locations

47 sites across 8 countries: United States, Australia, Czechia, France, Germany, Israel, New Zealand, Spain

Regulatory

• FDA-regulated drug study