A Study to Determine the Efficacy and Safety of Luspatercept in Adult Participants With Alpha (ฮฑ)-Thalassemia - Trial NCT05664737
Access comprehensive clinical trial information for NCT05664737 through Pure Global AI's free database. This Phase 2 trial is sponsored by Bristol-Myers Squibb and is currently Recruiting. The study focuses on Anemia. Target enrollment is 177 participants.
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Study Focus
Sponsor & Location
Bristol-Myers Squibb
Timeline & Enrollment
Phase 2
Dec 09, 2022
Jun 18, 2026
Primary Outcome
TD Cohort: Number of participants with โฅ 50% reduction from baseline in RBC transfusion burden with a reduction of at least 2 units during any continuous 12 weeks during Week 13-48 compared to 12-week interval immediately prior to date of first dose,NTD Cohort: Number of participants with an increase from baseline of โฅ 1.0 grams (g)/decilitre (dL) in mean hemoglobin (Hb) values over the continuous 12-week interval from Week 13 to Week 24 in the absence of transfusion
Summary
The purpose of the study is to determine the efficacy and safety of luspatercept plus best
 supportive care (BSC) vs placebo plus BSC on anemia in participants with ฮฑ-thalassemia
 hemoglobin H (HbH) disease.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05664737
Non-Device Trial