Trials / Active Not Recruiting
Active Not RecruitingNCT06045689
A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants
A Phase 3b, Open-label Study Evaluating the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) Initiated at Maximum Approved Dose in LR-MDS With IPSS-R Very Low-, Low-, or Intermediate-risk Who Require RBC Transfusions (MAXILUS)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood cell transfusions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Luspatercept | Specified dose on specified days. |
Timeline
- Start date
- 2023-10-05
- Primary completion
- 2025-10-01
- Completion
- 2027-12-30
- First posted
- 2023-09-21
- Last updated
- 2025-11-10
Locations
52 sites across 9 countries: United States, Belgium, Czechia, France, Germany, Italy, Poland, Puerto Rico, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06045689. Inclusion in this directory is not an endorsement.