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

PHASE2CompletedINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

February 5, 2018

Primary Completion Date

November 28, 2022

Study Completion Date

November 28, 2022

Conditions
Thalassemia
Interventions
DRUG

Luspatercept

Subjects will start with luspatercept at 1 mg/kg dose level every 3 weeks and can be dose escalated up to 1.25 mg/kg.

OTHER

Placebo

Placebo, Subcutaneous, every 21 days

OTHER

Best Supportive Care (BSC)

Best Supportive Care (BSC)

Trial Locations (16)

10043

Local Institution - 204, Orbassano

10700

Local Institution - 401, Bangkok

11527

Local Institution - 101, Athens

16128

Local Institution - 202, Genoa

20122

Local Institution - 201, Milan

60611

Local Institution - 503, Chicago

80131

Local Institution - 203, Naples

Local Institution - 206, Napoli

90027

Children's Hospital of Los Angeles, Los Angeles

Local Institution - 501, Los Angeles

94609

Children's Hospital and Research Center at Oakland, Oakland

115 27

Local Institution - 102, Athens

09121

Local Institution - 205, Cagliari

Universita degli Studi di Cagliari - ASL8, Cagliari

00961

Local Institution - 301, Hazmiyeh

WC1E 6AU

Local Institution - 601, London Bloomsbury

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

INDUSTRY

lead

Celgene

INDUSTRY