Beta-thalassemiaPhase 2NCT05567458
A Study to Evaluate Luspatercept (ACE-536) in Chinese Participants Who Require Regular Red Blood Cell Transfusions Due to Beta (β)-Thalassemia.
A Phase 2 study testing Luspatercept in people with Beta-thalassemia, run by Bristol-Myers Squibb at 10 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of luspatercept plus best supportive care (BSC) versus placebo plus BSC in participants who require regular red blood cell transfusions due to β-thalassemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Beta-thalassemia
- What is being tested?
- Luspatercept
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 10 sitesChina
- Study dates
- 17 Oct 2022to 1 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to adhere to the study visit schedule (for example, not scheduled to receive hematopoietic stem cell transplantation [HSCT]) and other protocol requirements.
- Participant has documented diagnosis of β-thalassemia or Hemoglobin E/β-thalassemia (β-thalassemia with mutation and/or multiplication of alpha (α) globin is allowed).
- Participant is regularly transfused, defined as: 6-25 RBC units in the 24 weeks prior to randomization and no transfusion-free period for >42 days during that period.
- Participant has Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
Who cannot join
- Participant has a diagnosis of Hemoglobin S/β-thalassemia or α-thalassemia (for example, Hemoglobin H).
- Participant has active hepatitis C virus (HCV) infection as demonstrated by a positive HCVribonucleic acid (RNA) test of sufficient sensitivity, or active infectious hepatitis B virus (HBV) as demonstrated by the presence of hepatitis B surface antigen (HBsAg) and/or HBVdeoxyribonucleic acid (DNA) positive, or known positive human immunodeficiency virus (HIV).
- Participant has a history of deep venous thrombosis or stroke or thromboembolic events (venous or arterial) requiring medical intervention ≤24 weeks prior to randomization.
- Participant uses chronic anticoagulant therapy, unless the treatment stopped at least 28 days prior to randomization. Anticoagulant therapies used for prophylaxis for surgery or high-risk procedures as well as low-molecular-weight heparin for superficial venous thrombosis and chronic aspirin are allowed.
- Participant who has EMH complications requiring treatment to control the growth of EMH mass(es) during the screening period.
- Participant used immunomodulatory imide drugs (IMiDs) ≤ 24 weeks prior to randomization
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Local Institution - 0009
Guangzhou, 510120
Local Institution - 0004
Guangzhou, 510515
Local Institution - 0006
Haikou, Hainan, 570203
Local Institution - 0008
Haikou, 570311
Local Institution - 0010
Kunming, Yunnan, 650032
Local Institution - 0007
Liuzhou, Guangxi, 545006
Local Institution - 0002
Maoming, Guangdong, 525447
Local Institution - 0003
Nanning, GX, 530012
Local Institution - 0001
Nanning, 530021
Local Institution - 0005
Shenzhen, Guangdong, 518035
About this study
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Luspatercept (ACE-536) in Chinese Adult Subjects Who Require Regular Red Blood Cell Transfusions Due to Beta (β)-Thalassemia
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of luspatercept plus best supportive care (BSC) versus placebo plus BSC in participants who require regular red blood cell transfusions due to β-thalassemia.
- Conditions
- Beta-thalassemia
- Being tested
- Luspatercept, Placebo
- Keywords
- Luspatercept, ACE-536, Transfusion burden
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuspaterceptDrug
Also called ACE-536, BMS-986346
Specified dose on specified days
PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Luspatercept | Experimental | Not described Receives: Drug: Luspatercept |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with ≥ 33% reduction from baseline in red blood cell (RBC) transfusion burden over any consecutive 24 weeks
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 - Week 48
Secondary outcomes (33)
Proportion of subjects with ≥ 33% reduction from baseline in RBC transfusion burden during any rolling 24-week interval compared to the 24-week interval prior to start of IP for luspatercept plus BSC versus placebo plus BSC.
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 134
Proportion of participants with ≥ 33% reduction from baseline in RBC transfusion burden over any consecutive 12 weeks
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 134
Proportion of participants with ≥ 50% reduction from baseline in RBC transfusion burden over any consecutive 12 weeks
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 134
Proportion of participants with ≥ 50% reduction from baseline in RBC transfusion burden over any consecutive 24 weeks
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 134
Proportion of participants with ≥ 33% reduction from baseline in RBC transfusion burden over Weeks 13-24
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 13-Week 24
Proportion of participants with ≥ 33% reduction from baseline in RBC transfusion burden over Weeks 37-48
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 37 to Week 48
Proportion of participants with ≥ 33% reduction from baseline in RBC transfusion burden over Weeks 1-24
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 24
Proportion of participants with ≥ 33% reduction from baseline in RBC transfusion burden over Weeks 25-48
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 25 to Week 48
Proportion of participants with ≥ 50% reduction from baseline in RBC transfusion burden over Weeks 13-24
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 13-Week 24
Proportion of participants with ≥ 50% reduction from baseline in RBC transfusion burden over Weeks 37-48
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 37 to Week 48
Proportion of participants with ≥ 50% reduction from baseline in RBC transfusion burden over Weeks 1-24
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 24
Proportion of participants with ≥ 50% reduction from baseline in RBC transfusion burden over Weeks 25-48
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 25 to Week 48
Best change from baseline in total RBC units transfused in 24 weeks within the first 48-week treatment period
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 48
Change from baseline in total RBC units transfused over Weeks 1-24
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 24
Change from baseline in total RBC units transfused over Weeks 25-48
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 25 to Week 48
Mean change from baseline in serum ferritin
Measured: 12 weeks prior to Dose 1 Day 1 (inclusive); Week 37 to Week 48
Change from baseline in Liver Iron Concentration (LIC) (mg/g dw) by magnetic resonance imaging (MRI)
Measured: Up to 96 weeks
Change from baseline in myocardial iron by T2-star (T2*) MRI
Measured: Up to 96 weeks
Change from baseline in mean daily dose of iron chelation therapy (ICT)
Measured: 12 weeks prior to Dose 1 Day 1 (inclusive); Week 37 to Week 48
Change from baseline in self-reported Health-related quality-of-life (HRQoL) assessed by TranQoL
Measured: Up to 48 weeks
Change from baseline in self-reported HRQoL assessed by SF-36
Measured: Up to 48 weeks
Proportion of participants who are transfusion independent for any consecutive ≥8 weeks during treatment
Measured: Week 1 to Week 134
Proportion of participants who are transfusion independent for any consecutive ≥12 weeks during treatment
Measured: Week 1 to Week 134
Duration of reduction in transfusion burden
Measured: Week 1 to Week 134
Duration of RBC transfusion independence (TI)
Measured: Week 1 to Week 134
Time to response
Measured: Week 1 to Week 134
Least number of transfusion events in 24 weeks within the first 48-week treatment period
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 48
Number of participants with Adverse Events (AEs)
Measured: Up to 4 years
Frequency of Antidrug antibodies (ADA)
Measured: Up to 2 years
Maximum plasma concentration (Cmax)
Measured: Up to 2 years
Area under the curve (AUC)
Measured: Up to 2 years
Change in spleen volume
Measured: Up to 96 weeks
Proportion of subjects, without increase in transfusion burden and with an increase of ≥ 1.0 g/dL in pre-transfusion Hb level on at least 2 separate tests (at least 60 days apart) during any rolling 24-week interval, compared to baseline
Measured: 24 weeks prior to Dose 1 Day 1 (inclusive); Dose 1 Day 2 through completion of 48-week treatment for last subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start17 Oct 2022
- Primary completion1 Aug 2025
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta-thalassemiaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567458
- Sponsor's protocol ID
- CA056-001
- Status last verified
- Aug 2025
- First submitted
- 3 Oct 2022
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Luspatercept (ACE-536) in Chinese Adult Subjects Who Require Regular Red Blood Cell Transfusions Due to Beta (β)-Thalassemia
- ClinicalTrials.gov ID
- NCT05567458
- Acronym / sponsor ID
- CA056-001
- Conditions
- Beta-thalassemia
- Keywords
- Luspatercept, ACE-536, Transfusion burden
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of luspatercept plus best supportive care (BSC) versus placebo plus BSC in participants who require regular red blood cell transfusions due to β-thalassemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Luspatercept | Experimental | Drug: Luspatercept |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant is willing and able to adhere to the study visit schedule (for example, not scheduled to receive hematopoietic stem cell transplantation [HSCT]) and other protocol requirements.
- Participant has documented diagnosis of β-thalassemia or Hemoglobin E/β-thalassemia (β-thalassemia with mutation and/or multiplication of alpha (α) globin is allowed).
- Participant is regularly transfused, defined as: 6-25 RBC units in the 24 weeks prior to randomization and no transfusion-free period for >42 days during that period.
- Participant has Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
Key exclusion criteria (6 listed)
- Participant has a diagnosis of Hemoglobin S/β-thalassemia or α-thalassemia (for example, Hemoglobin H).
- Participant has active hepatitis C virus (HCV) infection as demonstrated by a positive HCVribonucleic acid (RNA) test of sufficient sensitivity, or active infectious hepatitis B virus (HBV) as demonstrated by the presence of hepatitis B surface antigen (HBsAg) and/or HBVdeoxyribonucleic acid (DNA) positive, or known positive human immunodeficiency virus (HIV).
- Participant has a history of deep venous thrombosis or stroke or thromboembolic events (venous or arterial) requiring medical intervention ≤24 weeks prior to randomization.
- Participant uses chronic anticoagulant therapy, unless the treatment stopped at least 28 days prior to randomization. Anticoagulant therapies used for prophylaxis for surgery or high-risk procedures as well as low-molecular-weight heparin for superficial venous thrombosis and chronic aspirin are allowed.
- Participant who has EMH complications requiring treatment to control the growth of EMH mass(es) during the screening period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LuspaterceptAlso: ACE-536, BMS-986346Specified dose on specified days | Drug | Luspatercept |
| PlaceboSpecified dose on specified days | Drug | Placebo |
Primary outcome
Proportion of participants with ≥ 33% reduction from baseline in red blood cell (RBC) transfusion burden over any consecutive 24 weeks
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 - Week 48
33 secondary outcomes
Proportion of subjects with ≥ 33% reduction from baseline in RBC transfusion burden during any rolling 24-week interval compared to the 24-week interval prior to start of IP for luspatercept plus BSC versus placebo plus BSC.
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 134
Proportion of participants with ≥ 33% reduction from baseline in RBC transfusion burden over any consecutive 12 weeks
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 134
Proportion of participants with ≥ 50% reduction from baseline in RBC transfusion burden over any consecutive 12 weeks
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 134
Proportion of participants with ≥ 50% reduction from baseline in RBC transfusion burden over any consecutive 24 weeks
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 134
Proportion of participants with ≥ 33% reduction from baseline in RBC transfusion burden over Weeks 13-24
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 13-Week 24
Proportion of participants with ≥ 33% reduction from baseline in RBC transfusion burden over Weeks 37-48
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 37 to Week 48
Proportion of participants with ≥ 33% reduction from baseline in RBC transfusion burden over Weeks 1-24
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 24
Proportion of participants with ≥ 33% reduction from baseline in RBC transfusion burden over Weeks 25-48
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 25 to Week 48
Proportion of participants with ≥ 50% reduction from baseline in RBC transfusion burden over Weeks 13-24
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 13-Week 24
Proportion of participants with ≥ 50% reduction from baseline in RBC transfusion burden over Weeks 37-48
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 37 to Week 48
Proportion of participants with ≥ 50% reduction from baseline in RBC transfusion burden over Weeks 1-24
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 24
Proportion of participants with ≥ 50% reduction from baseline in RBC transfusion burden over Weeks 25-48
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 25 to Week 48
Best change from baseline in total RBC units transfused in 24 weeks within the first 48-week treatment period
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 48
Change from baseline in total RBC units transfused over Weeks 1-24
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 24
Change from baseline in total RBC units transfused over Weeks 25-48
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 25 to Week 48
Mean change from baseline in serum ferritin
Time frame: 12 weeks prior to Dose 1 Day 1 (inclusive); Week 37 to Week 48
Change from baseline in Liver Iron Concentration (LIC) (mg/g dw) by magnetic resonance imaging (MRI)
Time frame: Up to 96 weeks
Change from baseline in myocardial iron by T2-star (T2*) MRI
Time frame: Up to 96 weeks
Change from baseline in mean daily dose of iron chelation therapy (ICT)
Time frame: 12 weeks prior to Dose 1 Day 1 (inclusive); Week 37 to Week 48
Change from baseline in self-reported Health-related quality-of-life (HRQoL) assessed by TranQoL
Time frame: Up to 48 weeks
Change from baseline in self-reported HRQoL assessed by SF-36
Time frame: Up to 48 weeks
Proportion of participants who are transfusion independent for any consecutive ≥8 weeks during treatment
Time frame: Week 1 to Week 134
Proportion of participants who are transfusion independent for any consecutive ≥12 weeks during treatment
Time frame: Week 1 to Week 134
Duration of reduction in transfusion burden
Time frame: Week 1 to Week 134
Duration of RBC transfusion independence (TI)
Time frame: Week 1 to Week 134
Time to response
Time frame: Week 1 to Week 134
Least number of transfusion events in 24 weeks within the first 48-week treatment period
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 to Week 48
Number of participants with Adverse Events (AEs)
Time frame: Up to 4 years
Frequency of Antidrug antibodies (ADA)
Time frame: Up to 2 years
Maximum plasma concentration (Cmax)
Time frame: Up to 2 years
Area under the curve (AUC)
Time frame: Up to 2 years
Change in spleen volume
Time frame: Up to 96 weeks
Proportion of subjects, without increase in transfusion burden and with an increase of ≥ 1.0 g/dL in pre-transfusion Hb level on at least 2 separate tests (at least 60 days apart) during any rolling 24-week interval, compared to baseline
Time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Dose 1 Day 2 through completion of 48-week treatment for last subject
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Luspatercept in people with Beta-thalassemia, run by Bristol-Myers Squibb at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with ≥ 33% reduction from baseline in red blood cell (RBC) transfusion burden over any consecutive 24 weeks (time frame: 24 weeks prior to Dose 1 Day 1 (inclusive); Week 1 - Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.