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Reblozyl 75 mg powder for solution for injection

DRUG14 trials

Sponsors

Celgene Corp., Amsterdam UMC, GWT-Tud GmbH, Groupe Francophone Des Myelodysplasies, Universitaet Leipzig

Conditions

Alpha (α)-thalassemiaAnemia associated with myeloproliferative neoplasm (MPN)-associated myelofibrosis (MF)Anemia due to MDS with del5q with IPSS-R very lowBeta (β) ThalassemiaInherited anemiasLow risk myelodysplastic syndrom without RS having failed or being ineligible to Erythroid Stimulating AgentMyelodysplastic Syndrome (MDS)Myelodysplastic syndrome

Phase 1

Phase 2

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
RecruitingCTIS2022-502328-35-00
Celgene Corp.Alpha (α)-thalassemia
Start: 2023-01-30Target: 41Updated: 2025-11-14
A Phase 2a Study to Evaluate the Safety and Pharmacokinetics of Luspatercept (ACE-536) in Pediatric Participants with Beta (β) Thalassemia.
RecruitingCTIS2022-502499-22-00
Celgene Corp.Beta (β) Thalassemia
Start: 2019-10-15Target: 57Updated: 2025-10-09
A phase II, open-label, single arm study to evaluate the efficacy of Luspatercept in Erythropoiesis-stimulating agent naive lower-risk MDS patients with or without ring sideroblasts who do not require RBC transfusions (LENNON)
Active, not recruitingCTIS2024-516438-36-00
Universitaet Leipziglow or intermediate risk myelodysplastic syndromes (MDS) presenting with anemia, Patients with very low, transfusion independence (NTD) and naive towards ESA treatment
Start: 2022-09-13Target: 30Updated: 2025-07-17
Efficacy and Safety of Luspatercept for the Treatment of Anemia Due to Myelodysplastic Syndromes with del5q refractory/resistant/intolerant to Prior Treatments, Who Require Red Blood Cell Transfusion.
Not yet recruitingCTIS2024-519310-31-00
Associazione Qol-OneAnemia due to MDS with del5q with IPSS-R very low, low, or ineligible for +3
Target: 22Updated: 2025-11-28
A Phase 2 Open-Label Study to Evaluate Momelotinib in combination with Luspatercept in Participants with Transfusion Dependent Primary or Secondary Myelofibrosis
Not yet recruitingCTIS2024-518225-15-00
Glaxosmithkline Research & Development LimitedMyelofibrosis
Target: 51Updated: 2025-12-01
LUSPARA - A basket phase II clinical trial evaluating Luspatercept in patients affected with rare inherited anemias
Not yet recruitingCTIS2024-520200-26-00
Eurobloodnet AssociationInherited anemias
Target: 45Updated: 2026-01-16

Phase 3

A Phase 3, Open -label, Randomized 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) in ESA Naïve Subjects Who Require Red Blood Cell Transfusions.
Active, not recruitingCTIS2022-501485-22-00
Celgene Corp.Myelodysplastic syndrome (MDS)
Start: 2018-12-18Target: 201Updated: 2025-11-25
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE 536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-stimulating Agent (ESA)-naive Participants who are Non-transfusion Dependent (NTD): The “ELEMENT-MDS” Trial
RecruitingCTIS2022-500430-29-00
Celgene Corp.Myelodysplastic Syndrome (MDS)
Start: 2023-10-11Target: 162Updated: 2025-12-05
Improvement of MRI assessed cerebral Perfusion and oxygenation by luspatercept-induced Anemia Correction in non-transfusion dependent Thalassemia
RecruitingCTIS2023-504908-28-01
Amsterdam UMCNon-transfusion dependent beta-thalassmia
Start: 2024-07-14Target: 12Updated: 2024-03-18
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)
Active, not recruitingCTIS2023-504541-31-00
Celgene Corp.Myelodysplastic syndrome
Start: 2024-03-06Target: 72Updated: 2025-10-17
A Phase 3b, open-label, single-arm, rollover study to evaluate long-term safety in subjects who have participated in other luspatercept (ACE-536, also known as BMS 986346) clinical trials.
Active, not recruitingCTIS2022-502498-40-00
Celgene Corp.myelodysplastic syndrome (MDS); beta (β)-thalassemia (THAL); myelofibrosis (MF)
Start: 2019-07-26Target: 139Updated: 2025-12-22
A Phase 3, Double-Blind, Randomized Study to Compare the Efficacy and Safety 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
Active, not recruitingCTIS2023-507890-17-00
Celgene Corp.Anemia associated with myeloproliferative neoplasm (MPN)-associated myelofibrosis (MF)
Start: 2021-02-22Target: 150Updated: 2026-01-05
A phase IIIb, open-label, single arm study to evaluate the efficacy and safety of luspatercept in patients with lower-risk MDS and ringsideroblastic phenotype (MDS-RS)
Active, not recruitingCTIS2024-515069-33-00
GWT-Tud GmbHintolerant or ineligible to prior erythropoiesis-stimulating agents (ESA) treatment, low-, or intermediate-risk MDS-RS who require RBC transfusions and who are refractory +1
Start: 2022-02-15Target: 48Updated: 2025-10-01

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