CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 336 enrolled
Drug / intervention
Luspatercept +1 moredrug
Likely dose
Luspatercept 1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02604433
NCT02604433Phase 3Completed
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A Phase 3, Double-Blind, Placebo Controlled Multicenter Study to Determine the Efficacy and Safety of Luspatercept (ACE-536) in Adults With Transfusion Dependent Beta (B)-Thalassemia

Celgene·interventional·Posted Nov 13, 2015·Updated Apr 18, 2023

In Brief

A Phase 3 clinical trial evaluating Luspatercept and Placebo for Erythrocyte Transfusion and Beta-Thalassemia. Completed, enrolled 336 participants across 76 sites in 15 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErythrocyte Transfusion, Beta-Thalassemia
CountriesAustralia, Bulgaria, Canada, France, Greece, Israel, Italy, Lebanon, Malaysia, Taiwan, Thailand, Tunisia, Turkey (Türkiye), United Kingdom, United States
CollaboratorsAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 13, 2015
Enrollment StartMay 2, 2016
Primary CompletionJan 5, 2021
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 10.6 years ago

Interventions

Luspaterceptdrug

Subjects will start with luspatercept at 1 mg/kg dose level.

Placeboother

Placebo, Subcutaneous, every 21 days.