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NCT05664737Recruiting

A Study to Determine the Efficacy and Safety of Luspatercept in Adult Participants With Alpha (α)-Thalassemia

A Phase 2, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) for the Treatment of Anemia in Adults With Alpha (α)-Thalassemia
Bristol-Myers SquibbPhase 2ClinicalTrials.govbiological
Verified
Study focus
Disease/Condition
Anemia
Drug/Device/Intervention
Luspatercept
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Bristol-Myers Squibb
Location
Halifax,Maoming Shi,Haikou,Guangzhou,Nanning,Thessaloniki,Goudi,Patras,Cagliari,Genova,Napoli,Napoli,Orbassano,Bangkok,Topkapı,Altındağ, Canada,China,Greece,Italy,Thailand,Turkey
Timeline & enrollment
Phase
Phase 2
Start date
Dec 09, 2022
End date
Jun 18, 2026
Enrollment
177 participants
Primary outcome

TD Cohort: Number of participants with ≥ 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 ≥ 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 α-thalassemia
 hemoglobin H (HbH) disease.

ICD-10 classifications
Anaemia, unspecifiedOther anaemiasOther specified anaemiasIron deficiency anaemiaIron deficiency anaemia, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05664737
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.