145
Participants
Start Date
February 5, 2018
Primary Completion Date
November 28, 2022
Study Completion Date
November 28, 2022
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.
Placebo
Placebo, Subcutaneous, every 21 days
Best Supportive Care (BSC)
Best Supportive Care (BSC)
Local Institution - 204, Orbassano
Local Institution - 401, Bangkok
Local Institution - 101, Athens
Local Institution - 202, Genoa
Local Institution - 201, Milan
Local Institution - 503, Chicago
Local Institution - 203, Naples
Local Institution - 206, Napoli
Children's Hospital of Los Angeles, Los Angeles
Local Institution - 501, Los Angeles
Children's Hospital and Research Center at Oakland, Oakland
Local Institution - 102, Athens
Local Institution - 205, Cagliari
Universita degli Studi di Cagliari - ASL8, Cagliari
Local Institution - 301, Hazmiyeh
Local Institution - 601, London Bloomsbury
Lead Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
INDUSTRY
Celgene
INDUSTRY