Trials / Recruiting
RecruitingNCT05664737
A Study to Determine the Efficacy and Safety of Luspatercept in Adult Participants and to Evaluate the Safety and Pharmacokinetics in and Adolescent Participants With Alpha (α)-Thalassemia
A Phase 2, Study for the Treatment of Anemia With Alpha (α)-Thalassemia to Determine the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) in Adults and Evaluate the Safety and Pharmacokinetics in Adolescents
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 189 (estimated)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the efficacy and safety of luspatercept plus best supportive care (BSC) vs placebo plus BSC on anemia in adult participants with α-thalassemia hemoglobin H (HbH) disease and determine the safety and drug levels in adolescent participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Luspatercept | Specified dose on specified days |
| DRUG | Placebo | Specified dose on specified days |
Timeline
- Start date
- 2022-12-09
- Primary completion
- 2027-07-16
- Completion
- 2034-08-14
- First posted
- 2022-12-27
- Last updated
- 2026-03-24
Locations
36 sites across 11 countries: Canada, China, Greece, Hong Kong, Italy, Malaysia, Saudi Arabia, Singapore, Taiwan, Thailand, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05664737. Inclusion in this directory is not an endorsement.