5 active not recruiting, 4 not yet recruiting, 2 completed, 1 recruiting. 12 Phase 3, 2 Phase 2.
By phase and status
Follow luspatercept: new trials by email Literature Review of luspatercept trials Research Report on luspatercept
Trials (filtered) newest first · largest first
All 12 trials
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
Efficacy and Safety of Maximum Labeled Dose Luspatercept in Lower-Risk Myelodysplastic Syndromes Luspatercept - Myelodysplastic Syndromes | Phase 3 | Not yet recruiting | 75 | 2026-10-31 | 2026-10-26 |
Luspatercept vs Epoetin in Treating Poor Erythroid Engraftment for Hematological Malignancies Luspatercept, Epoetin - Luspatercept, Epoetin | Phase 2 / Phase 3 | Not yet recruiting | 90 | 2026-06-15 | 2026-06-09 |
Luspatercept in Preventing Poor Erythroid Engraftment for Hematological Malignancies With Moderate to Severe Myelofibrosis Luspatercept, Control - Luspatercept, Poor Erythroid Engraftment | Phase 2 / Phase 3 | Not yet recruiting | 196 | 2026-05-01 | 2026-04-20 |
AZA+Lus VS AZA Monotherapy in HR-MDS Azacitidine (AZA), Luspatercept - Higher-risk Myelodysplastic Syndrome | Phase 3 | Not yet recruiting | 86 | 2025-04-01 | 2025-04-15 |
ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions Luspatercept, Epoetin Alfa - Myelodysplastic Syndromes | Phase 3 | Active not recruiting | 402 | 2023-10-24 | 2026-06-30 |
A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants Luspatercept - Myelodysplastic Syndromes | Phase 3 | Active not recruiting | 106 | 2023-10-05 | 2026-06-15 |
Assessment of Effectiveness and Safety of Luspatercept in Patients Suffering From Lower-risk Myelodysplastic Syndrome. Luspatercept - Myelodysplastic Syndromes | Phase 3 | Active not recruiting | 70 | 2021-10-27 | 2025-09-30 |
An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions ACE-536, Placebo - Myeloproliferative Disorders, Myelofibrosis | Phase 3 | Active not recruiting | 313 | 2021-02-25 | 2026-07-16 |
A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials Luspatercept - Myelodysplastic Syndromes (MDS), Beta-thalassemia | Phase 3 | Recruiting | 665 | 2019-08-12 | 2026-07-01 |
A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve Luspatercept, Epoetin alfa - Myelodysplastic Syndromes | Phase 3 | Active not recruiting | 363 | 2019-01-02 | 2024-11-20 |
An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (β) Thalassemia Luspatercept, Placebo - Erythrocyte Transfusion, Beta-Thalassemia | Phase 3 | Completed | 336 | 2016-05-02 | 2023-04-18 |
A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes Luspatercept, Placebo - Myelodysplastic Syndromes | Phase 3 | Completed | 229 | 2016-02-09 | 2021-12-17 |
Conditions studied
Myelodysplastic Syndromes (7) · Anemia (5) · Hematologic Neoplasms (2) · Myeloproliferative Disorders (2) · Primary Myelofibrosis (2) · beta-Thalassemia (2) · Anemia, Refractory, with Excess of Blasts (1)
Sponsors
Celgene (5) · Bristol-Myers Squibb (2) · Nanfang Hospital, Southern Medical University (2) · GWT-TUD GmbH (1) · Institute of Hematology & Blood Diseases Hospital, China (1) · Peking Union Medical College Hospital (1)
Countries
France (7) · Germany (7) · Italy (7) · Spain (7) · United States (7) · Canada (6) · Australia (5) · Belgium (5) · China (5) · Greece (5) · United Kingdom (5) · Czechia (4) · Israel (4) · Poland (4) · Turkey (Türkiye) (4)
Top investigators
Qifa Liu (2) · Rodrigo Ito, MD (1)
Results publications
PMID 37311468, PMID 20424252, PMID 28096091, PMID 29895954, PMID 30504333, PMID 30602619, PMID 30617198, PMID 31914241, PMID 32089218, PMID 32212518, PMID 33570654, PMID 34002031, PMID 36635381, PMID 37704579, PMID 37782758, PMID 39038479, PMID 39947215, PMID 40377899, PMID 41549790, PMID 41857682
NIH funding
2015 (1)