A Study to Evaluate Luspatercept (ACE-536) in Chinese Participants Who Require Regular Red Blood Cell Transfusions Due to Beta (β)-Thalassemia.
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
94actual
Sites
10
Country
China
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 | 2022-10-17 | actual | When the study began enrolling |
| Primary completion | 2025-08-01 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-08-01 | estimated | The whole study's end, after follow-up |
| First posted | 2022-10-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Beta-thalassemia
Interventions
- Drug: Luspatercept — also filed as ACE-536, BMS-986346
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFProportion of participants with ≥ 33% reduction from baseline in red blood cell (RBC) transfusion burden over any consecutive 24 weeks
measured 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 - Week 48
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