myelodysplastic neoplasms/syndromes (MDS)
Conditions
Brief summary
Proportion of participants achieving transfusion independence (TI) for ≥ 8 weeks from baseline through week 24
Detailed description
1. Proportion of participants achieving TI for ≥ 24 weeks from baseline through week 48, 2. Proportion of participants with HTB achieving TI for ≥ 8 weeks from baseline through week 24, 3. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), 4. Change from baseline in clinical laboratory values, vital signs, and electrocardiograms (ECGs)
Interventions
DRUGelritercept
DRUGPlacebo to match ker-050 solution for injection
Sponsors
Takeda Development Center Americas Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving transfusion independence (TI) for ≥ 8 weeks from baseline through week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants achieving TI for ≥ 24 weeks from baseline through week 48, 2. Proportion of participants with HTB achieving TI for ≥ 8 weeks from baseline through week 24, 3. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), 4. Change from baseline in clinical laboratory values, vital signs, and electrocardiograms (ECGs) | — |
Countries
Bulgaria, Czechia, France, Germany, Hungary, Ireland, Italy, Lithuania, Poland, Spain, Sweden
Outcome results
None listed