Overview

A Study to Determine the Efficacy and Safety of Luspatercept in Adults With Non Transfusion Dependent Beta (β)-Thalassemia

Status:
Active, not recruiting

Trial end date:
2022-03-14

Target enrollment:

Participant gender:

Summary

This is a Phase 2, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in adults with non-transfusion dependent beta (β)-thalassemia. The study is divided into the Screening Period, Double-blind Treatment Period (DBTP) and Post-Treatment Follow-up Period (PTFP). It is planned to randomize approximately 150 subjects at a 2:1 ratio of luspatercept versus placebo.

Phase:

Phase 2

Details

Lead Sponsor:

Celgene

Collaborators:

Acceleron Pharma Inc.
Acceleron Pharma, Inc.

Treatments:

Luspatercept