Overview

An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (β) Thalassemia

Status:
Active, not recruiting

Trial end date:
2025-06-07

Target enrollment:

Participant gender:

Summary

This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) plus Best supportive care (BSC) versus placebo plus BSC in adults who require regular red blood cell transfusion due to (β)-thalassemia. The study is divided into the following periods: - Historical Period, - Screening/Run-in Period, - Double-blind Treatment Period (48 weeks), - Double-blind Long-term Treatment Period, (at the investigator's discretion an additional 48 weeks), - Open-Label Phase post unblinding and upon Data Monitoring Committee positive recommendation - Post-treatment Follow-up Period

Phase:

Phase 3

Details

Lead Sponsor:

Celgene
Celgene Corporation

Collaborators:

Acceleron Pharma Inc.
Acceleron Pharma, Inc.

Treatments:

Luspatercept