MedTrace Logo

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

NCT05664737 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2026-03-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Luspatercept

Specified dose on specified days

DRUG

Placebo

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-09
Primary Completion
2027-07-16
Completion
2034-08-14
FDA Drug
Yes

Countries

  • Canada
  • China
  • Greece
  • Hong Kong
  • Italy
  • Malaysia
  • Saudi Arabia
  • Singapore
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664737 on ClinicalTrials.gov