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

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NCT05664737 · readout in 331 d

Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.

Phase

Phase 2

Status

Recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

189estimated

Sites

Countries

Canada, China, Greece +8

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2022-12-09

actual

When the study began enrolling

Primary completion

2027-07-16

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2034-08-14

estimated

The whole study's end, after follow-up

First posted

2022-12-27

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-10

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Anemia

Interventions

Biological: Luspatercept — also filed as BMS-986346, ACE-536, REBLOZYL
Drug: Placebo

Primary outcomes

what the primary-completion date above is the date OF

Number of participants with ≥ 50% reduction from baseline in RBC transfusion burden with a reduction of at least 2 units during any continuous 12 weeks during Week 13-48 compared to 12-week interval immediately prior to date of first dose

measured Up to Week 48

Number of participants with an increase from baseline of ≥ 1.0 grams (g)/decilitre (dL) in mean hemoglobin (Hb) values over the continuous 12-week interval from Week 13 to Week 24 in the absence of RBC transfusion

measured Up to Week 24

Dose-limiting 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

measured Up to Week 3

Number of participants with adverse events (AEs)

measured Up to 5 years

Pharmacokinetics (PK): Serum concentration of Luspatercept

measured Up to Week 108

Publications

PMID 37606495 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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