Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Luspatercept

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44349   clinical trials with a EudraCT protocol, of which   7376   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    16 result(s) found for: Luspatercept. Displaying page 1 of 1.
    EudraCT Number: 2018-002915-93 Sponsor Protocol Number: ACE-536-LTFU-001 Start Date*: 2019-06-26
    Sponsor Name:Celgene Corporation
    Full Title: A phase 3B, open-label, single-arm, rollover study to evaluate long-term safety in subjects who have participated in other Luspatercept (ACE-536) clinical trials.
    Medical condition: Prior participation on a clinical trial of luspatercept (ACE-536) in protocols eligible for participation in this study ACE-536-LTFU-001 with the following medical conditions: - myelodysplastic syn...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10074356 Non-transfusion dependent thalassemia LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10068361 MDS LLT
    20.1 100000004850 10054658 Thalassemia LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074689 Post polycythemia vera myelofibrosis LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074690 Post essential thrombocythemia myelofibrosis LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074691 Post polycythaemia vera myelofibrosis LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074692 Post essential thrombocythaemia myelofibrosis LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028537 Myelofibrosis PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077161 Primary myelofibrosis PT
    20.0 100000004851 10002272 Anemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) SE (Trial now transitioned) NL (Trial now transitioned) GB (GB - no longer in EU/EEA) FR (Trial now transitioned) GR (Trial now transitioned) ES (Ongoing) BE (Completed) BG (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003190-34 Sponsor Protocol Number: ACE-536-MDS-002 Start Date*: 2019-01-02
    Sponsor Name:Celgene Corporation
    Full Title: 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 Ris...
    Medical condition: Myelodysplastic syndrome (MDS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10068361 MDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Trial now transitioned) LT (Trial now transitioned) FR (Trial now transitioned) PT (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) BE (Trial now transitioned) PL (Trial now transitioned) AT (Trial now transitioned) IT (Trial now transitioned) GR (Trial now transitioned) HU (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-000208-13 Sponsor Protocol Number: ACE-536-B-THAL-004 Start Date*: 2019-12-09
    Sponsor Name:Celgene Corporation
    Full Title: A phase 2a study to evaluate the safety and pharmacokinetics of Luspatercept (ACE-536) in paediatric participants who require regular red blood cell transfusions due to beta (β) thalassemia
    Medical condition: Beta-Thalassemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10054660 Thalassemia beta LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) GR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-003225-33 Sponsor Protocol Number: ACE-536-B-THAL-002 Start Date*: 2018-01-08
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Determine the Efficacy and Safety of Luspatercept (ACE-536) versus Placebo in Adults with Non Transfusion Dependent Bet...
    Medical condition: Non transfusion dependent β-thalassemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10074356 Non-transfusion dependent thalassemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-003224-31 Sponsor Protocol Number: ACE-536-B-THAL-001 Start Date*: 2016-03-14
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Determine the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell...
    Medical condition: Adults who require regular Red Blood Cell (RBC) transfusions due to Beta-Thalassemia.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10054658 Thalassemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Prematurely Ended) BG (Completed) GR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-000607-36 Sponsor Protocol Number: ACE-536-MF-002 Start Date*: 2021-06-01
    Sponsor Name:Celgene Corporation
    Full Title: 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 CONCOM...
    Medical condition: Anemia associated with myeloproliferative neoplasm (MPN)-associated myelofibrosis (MF)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077161 Primary myelofibrosis PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074689 Post polycythemia vera myelofibrosis LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074690 Post essential thrombocythemia myelofibrosis LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074692 Post essential thrombocythaemia myelofibrosis LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074691 Post polycythaemia vera myelofibrosis LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028537 Myelofibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) CZ (Trial now transitioned) AT (Trial now transitioned) IE (Trial now transitioned) GR (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) HU (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-003454-41 Sponsor Protocol Number: ACE-536-MDS-001 Start Date*: 2016-05-10
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 3, Double-Blind, Randomized Study To Compare The Efficacy And Safety Of Luspatercept (ACE-536) Versus Placebo For The Treatment Of Anemia Due To IPSS-R Very Low, Low, Or Intermediate Risk M...
    Medical condition: Subjects with ring sideroblasts who require regular Red Blood Cell (RBC) Transfusions due to anemia due to Myelodysplastic Syndromes (MDS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10002272 Anemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) NL (Completed) BE (Completed) SE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000322-35 Sponsor Protocol Number: ACE-536-MF-001 Start Date*: 2017-08-22
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Luspatercept (ACE-536) in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis and Anemia With and With...
    Medical condition: Anemia associated with myeloproliferative neoplasm (MPN)-associated myelofibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077161 Primary myelofibrosis PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074689 Post polycythemia vera myelofibrosis LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074690 Post essential thrombocythemia myelofibrosis LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074692 Post essential thrombocythaemia myelofibrosis LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074691 Post polycythaemia vera myelofibrosis LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028537 Myelofibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-004928-15 Sponsor Protocol Number: CA056-015 Start Date*: 2022-09-28
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 2, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) for the Treatment of Anemia in Adults with Alpha...
    Medical condition: Alpha (α)-thalassemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10054659 Thalassemia alpha LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001538-20 Sponsor Protocol Number: QOL-ONEPhoenix Start Date*: 2022-10-19
    Sponsor Name:ASSOCIAZIONE QOL-ONE
    Full Title: 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.
    Medical condition: Anemia due to MDS with del5q with IPSS-R very low, low, or intermediate risk MDS and a bone marrow blast count of < 5% , Refractory or intolerant to, or ineligible for, prior ESA treatment and for ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10028532 Myelodysplasia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-005736-30 Sponsor Protocol Number: CDAII-LUSPA_FA02-2020 Start Date*: 2023-07-17
    Sponsor Name:FOndazione per la Ricerca sulle ANemie ed EMoglobinopatie in ItaliA - For Anemia
    Full Title: A phase II, multicenter, open label study to evaluate the efficacy and safety of Luspatercept (ACE-536) in adult patients with Congenital Dyserythropoietic Anemia type Il (CDA ll).
    Medical condition: Congenital Dyserythropoietic Anemia type II (CDAII)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10010331 - Congenital, familial and genetic disorders 10081457 Congenital dyserythropoietic anaemia PT
    21.1 10010331 - Congenital, familial and genetic disorders 10081457 Congenital dyserythropoietic anaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-004899-18 Sponsor Protocol Number: LUSPLUS Start Date*: 2021-09-17
    Sponsor Name:GWT-TUD GmbH
    Full Title: A phase IIIb, open-label, single arm study to evaluate the efficacy and safety of luspatercept in patients with lower-risk MDS and ring-sideroblastic phenotype (MDS-RS)
    Medical condition: Lower-risk myelodysplastic syndrome with ring-sideroblastic phenotype (MDS-RS)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028534 Myelodysplastic syndrome NOS LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10068361 MDS LLT
    20.0 10005329 - Blood and lymphatic system disorders 10050910 Bone marrow disorder NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000596-37 Sponsor Protocol Number: COMBOLA Start Date*: 2021-10-29
    Sponsor Name:Groupe Francophone des Myélodysplasies
    Full Title: A randomized phase I/ II multicenter study evaluating combination of luspatercept in LR-MDS without RS having failed or being ineligible to ESA
    Medical condition: Low risk myelodysplastic syndrom without RS having failed or being ineligible to Erythroid Stimulating Agent
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10028536 Myelodysplastic syndromes HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-001280-13 Sponsor Protocol Number: A536-05 Start Date*: 2014-09-03
    Sponsor Name:Acceleron Pharma Inc.
    Full Title: An Open-Label Extension Study to Evaluate the Long-Term Effects of ACE-536 for the Treatment of Anemia in Patients with Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Previously Enrolle...
    Medical condition: Myelodysplastic Syndromes (MDS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    20.0 100000004851 10028536 Myelodysplastic syndromes HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2022-001253-23 Sponsor Protocol Number: 4202-ONC-203 Start Date*: 2022-09-23
    Sponsor Name:Forma Therapeutics, Inc.
    Full Title: A Phase 2 Open-Label Study to Evaluate Etavopivat for the Treatment of Anemia in Patients with Myelodysplastic Syndromes (MDS)
    Medical condition: Anemia of myelodysplastic syndromes (MDS), inherited hemolytic anemias, and other refractory anemias
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-002523-14 Sponsor Protocol Number: A536-03 Start Date*: 2012-12-20
    Sponsor Name:Acceleron Pharma Inc.
    Full Title: A Phase 2, Open-Label, Ascending Dose Study of ACE-536 for the Treatment of Anemia in Patients with Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
    Medical condition: Myelodysplastic Syndromes (MDS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    20.0 100000004851 10028536 Myelodysplastic syndromes HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Jul 13 02:16:53 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA