Bristol-Myers Squibb: Anemia trials

The registry lists 14 Anemia studies with Bristol-Myers Squibb as lead sponsor. 1 are open to participants now and 7 have results posted.

Phase 2 6Phase 3 7Phase 4 1No phase 1(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• First-Line Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic NeoplasmsNot yet recruitingNCT07752121
• 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 TransfusionsActive, not recruitingNCT04717414Phase 3Results posted
• An Efficacy and Safety Study of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in Japanese Subjects Who Are Not Requiring Red Blood Cell TransfusionCompletedNCT03900715Phase 2Results posted
• 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 NaïveActive, not recruitingNCT03682536Phase 3Results posted
• A Safety and Efficacy Study to Evaluate Luspatercept in Subjects With Myeloproliferative Neoplasm-associated Myelofibrosis Who Have Anemia With and Without Red Blood Cell-transfusion DependenceCompletedNCT03194542Phase 2Results posted
• A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic SyndromesCompletedNCT02631070Phase 3Results posted
• A Phase 2a Study To Evaluate The Pharmacokinetics, Safety, Efficacy, Tolerability, And Pharmacodynamics of Sotatercept (ACE-011) for the Correction of Anemia in Subjects With End-stage Renal Disease on Hemodialysis.CompletedNCT01146574Phase 2Results posted
• A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Lower Risk Myelodysplastic Syndrome (MDS) Without Del 5qCompletedNCT01029262Phase 3Results posted
• A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome ParticipantsActive, not recruitingNCT06045689Phase 3
• ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood TransfusionsActive, not recruitingNCT05949684Phase 3
• A Study to Evaluate the Safety and Effectiveness of Luspatercept for the Treatment of Transfusion-dependent (TD) Anemia Associated With Myelodysplastic Syndromes (MDS) & Beta-thalassemia (β-Thal) in IndiaActive, not recruitingNCT05891249Phase 4
• 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)-ThalassemiaActive, not recruitingNCT05664737Phase 2
• A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)Active, not recruitingNCT05469737Phase 2/3
• A Study to Evaluate the Efficacy, Drug Levels and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Chinese and Japanese Participants With Ring Sideroblasts Who Require Red Blood Cell TransfusionsCompletedNCT04477850Phase 2