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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)-Thalassemia

StatusActive, Not Recruiting
PhasePhase 2
Started2022-12-09
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
Study Status, Contacts/Locations v37
Enrollment closed, study ongoing
Trial sites reduced: 36 → 31 locations
2026-08-06
Study Status, Outcome Measures, Eligibility v36
Eligibility criteria+149 characters
Key Inclusion Criteria: Adult participant≥ 18 years with documen [...] A-Thal HbH disease with Transfusion dependence defined as:. i) TD participant: ≥ 6 RBC units during the 24 weeks prior to randomization. ii) NTD participant:< 6 RBC units during the 24 weeks prior to r [...] A-Thal HbH disease with transfusion dependence defined as:. i) TD participant: ≥ 4 RBC events during the 24 weeks prior to [...] ave a history of regular transfusions for at least 2 years. ii) NTD participant:< 4 RBC events during the 24 weeks prior to [...] in values within 21 days post-transfusion will be excluded. iii) Participant has Karnofs [...] [...]
Secondary endpoints64 to 65 entries
Percent Change from Baseline in Biomarkers for Erythropoiesis at Week 8448 Percent Change from Baseline in Biomarkers and Parameters for Iron Homeostasis at Week 8448 Percent Change from Baseline in HB Variants including HBH Assessment of Hematologic assessmentsParameters
2026-06-23
Study Status, Contacts/Locations v35
Study sitesdetails revised at 3 of 36 sites
2026-03-23
Study Status, Study Design v34
Enrollment target249→189
2026-02-11
Study Status, Contacts/Locations, IPDSharing v33
Study sites36 entries, revised
LocalHospital InstitutionTunku Azizah King Saud University (KSU) - 0032College of Medicine LocalKK InstitutionWomen's and Children's Hospital Naresuan University Hospital Hacettepe Üniversitesi Tıp Fakültesi Istanbul Universitesi - 0034 LocalIstanbul InstitutionTip -Fakultesi 0036 Local(ITF) Institution - 0031 Local Institution - 0027 Local Institution - 0021Hastanesi
Show 32 earlier versions
2025-08-19
Study Status, Contacts/Locations v32
Study sites36 entries, revised
Local"Universita Institutiondegli Studi della Campania ""Luigi Vanvitelli"" - 0019 Local InstitutionAOU - 0033Clinica Pediatrica" Hospital Sultanah Aminah
2025-06-09
Study Status, Contacts/Locations v31
Study sites36 entries, revised
LocalSun InstitutionYat-sen Memorial Hospital, Sun Yat-Sen 0029University Shenzhen Second People's Hospital Local Institution - 00300011 HainanLocal Medical CollegeInstitution - First0012 Local AffiliatedInstitution Hospital First- People's Hospital of Yunnan Province Queen Mary Hospital0025
2025-05-09
Study Status, Contacts/Locations, References v30
Study sites36 entries, revised
LocalQueen InstitutionMary - 0025Hospital
2025-01-17
Study Status, Contacts/Locations v29
Study sitesdetails revised at 1 of 36 sites
2024-12-12
Study Identification, Study Status, Outcome Measures, Eligibility, Contacts/Locations, References v28
Primary completion date2025-11-05→2027-07-16
Completion date2026-06-18→2034-08-14
Eligibility criteria+794 characters
Key Inclusion Criteria: Adult participant≥ 18 years with documented diagnosis of αA-thalassemiaThal HbH disease with Transfusion dependence for TD participants defined as:. TD participant: ≥ 6 RBC units during the 24 weeks prior to randomization and no transfusion-free period for > 56 days during the 24 weeks prior to randomization. AdultNTD participant ≥ 18 years with documented diagnosis of α-thalassemia HbH disease with Transfusion dependence for NTD participants defined as :< 6 RBC units during the 24 weeks prior to randomization(transfusion due to conditions other than A-Thal will not be [...] [...]
Secondary endpointsdetails revised at 2 of 64 entries
Study sites36 entries, revised
GeneralLocal Hospital of Larissa "General Hospital ""IPPOKRATEIO""" "The""Aghia Sophia"" Children's Hospital" Ente Ospedaliero Ospedali Galliera Azienda OspedalieroInstitution - Universitaria0007 Local SanInstitution Luigi- Gonzaga0006 "A.O.R.N.Local ""A.Institution Cardarelli"""- 0009 Local Institution - 0026 Local Institution - 0020 Local Institution - 0028
Study title+64 characters
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)-Thalassemia
2024-09-11
Study Status, Contacts/Locations v27
Study sites33→36
2024-08-05
Study Status, Contacts/Locations, References v26
Study sites30→33
2024-07-08
Study Status, Contacts/Locations v25
Study sites28→30
2024-02-23
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v24
Enrollment target177→249
InterventionsBest Supportive Care (Other), Luspatercept (Biological), Placebo (Drug)→Luspatercept (Biological), Placebo (Drug)
Eligibility criteria-222 characters
Key Inclusion Criteria: ParticipantAdult hasparticipant ≥ 18 years with documented diagnosis of α-thalassemia hemoglobin H (HbH) disease (electrophoresis⎯with orTransfusion high-performance liquid chromatography [HPLC]⎯based methodsdependence for Hb variant analyses are accepted), with or without transfusion dependence; compounded combination with β-thalassemia is allowed if at least 1 non-mutated β-chain gene is present. TD: i) TD participant:participants (1)defined as ≥ 6 RBC units during the 24 weeks prior to randomization; and (2) Nono transfusion-free period for > 56 days during the 24 we [...] [...]
Secondary endpoints48 to 64 entries
TD Cohort: Number of participants with ≥ 33% reduction from baseline in [...] to 24-week interval immediately prior to date of first dose TD Cohort: The longest duration with ≥ 50% reduction from baseline in RBC transfusion burden with a reduction of at least 2 units TD Cohort: Number of RBC transfusion units from week 1 to week 48 NTD Cohort: Change from baseline in hemoglobin in the absence of transfusion at Week 24 NTD Cohort: The longest duration of an increase from baseline of ≥ 1.0 g [...] values starting from Week 13 in the absence of transfusion NTD Cohort: Time Duration with an increase from basel [...] [...]
Primary endpoints2 to 5 entries
NTDDose-limiting Cohort:toxicities (DLTs) defined as observance of ≥ Grade 3-related hemolytic crises or ≥ Grade 3-related event outside of the known safety profile occurring within the 21 days from their first dose of study therapy Number of participants with adverse events (AEs) Number of participants with an increase from baseline of ≥ 1 [...] 12-week interval from Week 13 to Week 24 in the absence of RBC transfusion TD Cohort: Number of participants with ≥ 50% reduction from baseline in [...] to 12-week interval immediately prior to date of first dose Pharmacokinetics (PK): Serum concentration of Lusp [...]
Study sites28 entries, revised
LocalNanfang InstitutionHospital of Southern Medical University First People's Hospital of Yunnan Province The First Affiliated Hospital of Guangxi Medical University General Hospital of Larissa "General Hospital ""IPPOKRATEIO""" Azienda Ospedaliero - 0015Universitaria San Luigi Gonzaga LocalSiriraj Institution - 0012 Local Institution - 0016 Local Institution - 0007 Local Institution - 0006 Local Institution - 0020 Local Institution - 0001Hospital
Study title+15 characters
A Study to Determine the Efficacy and Safety of Luspatercept in Adult and Adolescent Participants With Alpha (α)-Thalassemia
2024-01-02
Study Status, Contacts/Locations, References v23
Study sites28 entries, revised
LocalThe InstitutionFirst -People's 0013Hospital of Foshan LocalMaoming InstitutionPeople's -Hospital People's 0017Liberation Army The 923rd Hospital LocalHainan InstitutionGeneral -Hospital Liuzhou 0014People's Hospital LocalChina InstitutionMedical -University 0002 Local Institution - 0023 Local Institution - 0003Hospital
2023-12-06
Study Status, Contacts/Locations v22
Study sitesdetails revised at 1 of 28 sites
2023-10-11
Study Status, Contacts/Locations v21
Study sites26→28
2023-09-26
Study Status, Contacts/Locations v20
Study sites25→26
2023-07-25
Study Status, Contacts/Locations v19
Study sitesdetails revised at 1 of 25 sites
2023-07-13
Study Status, Contacts/Locations v18
Study sitesdetails revised at 2 of 25 sites
2023-07-10
Study Status, Contacts/Locations v17
Study sites24→25
2023-06-07
Study Status, Contacts/Locations v16
Study sitesdetails revised at 1 of 24 sites
2023-06-02
Study Status, Contacts/Locations v15
Study sites23→24
2023-05-17
Study Status, Contacts/Locations v14
Study sites22→23
2023-05-16
Study Status, Contacts/Locations v13
Study sitesdetails revised at 1 of 22 sites
2023-05-15
Study Status, Contacts/Locations v12
Study sitesdetails revised at 1 of 22 sites
2023-05-12
Study Status, Contacts/Locations v11
Study sitesdetails revised at 2 of 22 sites
2023-05-03
Study Status, Contacts/Locations v10
Study sites19→22
2023-05-01
Study Status, Contacts/Locations v9
Study sites18→19
2023-04-21
Study Status, Contacts/Locations v8
Study sites17→18
2023-04-19
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 17 sites
2023-04-04
Study Status, Contacts/Locations v6
Study sites16→17
2023-03-15
Study Status, Contacts/Locations v5
Study sites14→16
2023-03-07
Study Status, Contacts/Locations v4
Study sites13→14
2023-02-17
Study Status, Contacts/Locations v3
Study sites12→13
2023-02-09
Study Status, Contacts/Locations, IPDSharing v2
Study sitesdetails revised at 1 of 12 sites
2023-01-03
Study Status v1
Re-verified, no change to tracked fields
2022-12-22
Original filing
The purpose of the study is to evaluate the efficacy and safety of luspatercept plus best supportive care (BSC) vs placebo plus BSC on anemia in adult participants with α-thalassemia hemoglobin H (HbH) disease and determine the safety and drug levels in adolescent participants.
Trial Details
NCT Number NCT05664737
Lead Sponsor Bristol-Myers Squibb
Conditions Anemia
Enrollment 189 participants
Start Date 2022-12-09
Primary Completion 2027-07-16 (estimated)
Study Completion 2034-08-14 (estimated)
Updated on ClinicalTrials.gov 2026-09-10