A Study to Evaluate the Safety and Effectiveness of Luspatercept for the Treatment of Transfusion-dependent (TD) Anemia Associated With Myelodysplastic Syndromes (MDS) & Beta-thalassemia (β-Thal) in India
← catalyst calendarNCT05891249 · readout in 850 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 4
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
85estimated
Sites
9
Country
India
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-06-05 | actual | When the study began enrolling |
| Primary completion | 2028-12-16 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-12-16 | estimated | The whole study's end, after follow-up |
| First posted | 2023-06-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Anemia
Intervention
- Biological: Luspatercept — also filed as ACE-536, REBLOZYL, BMS-986346, ROJUZDA
Primary outcomes
what the primary-completion date above is the date OFβ-Thal Cohort: Number of participants with treatment-related adverse events (AEs) of grade 3 or higher
measured Up to 57 weeks
MDS-Ring Sideroblasts (RS) Cohort: Number of participants with treatment-related AEs of grade 3 or higher
measured Up to 54 weeks
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