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A Study to Test the Safety, Tolerability, and Efficacy of an Antibody, REGN7999, Injected Under the Skin for the Treatment of Iron Overload in Adult Participants With Non-Transfusion Dependent β-thalassemia, Using MRI Scans to Measure Iron Levels in the Body
Sponsor: Regeneron Pharmaceuticals
Summary
This study is researching an experimental drug called REGN7999 (called "study drug"). The study is focused on patients with non-transfusion dependent beta-thalassemia. The aim of the study is to see how safe and effective the study drug is. The study is looking at several other research questions, including: * Whether the study drug lowers extra iron levels in the body * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Official title: A PHASE 2, TWO-PART, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SUBCUTANEOUSLY ADMINISTERED REGN7999 (AN INHIBITOR OF TMPRSS6) IN PARTICIPANTS WITH IRON OVERLOAD DUE TO NON-TRANSFUSION DEPENDENT β-THALASSEMIA
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
95
Start Date
2024-09-30
Completion Date
2028-01-24
Last Updated
2026-03-18
Healthy Volunteers
No
Interventions
REGN7999
Administered subcutaneous (SC)
Placebo
Administered SC
Locations (26)
Weill Cornell Medicine
New York, New York, United States
K Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, Georgia
Medinvest Institute of Hematology and Transfusiology Limited
Tbilisi, Georgia
Children's Hospital Agia Sophia
Athens, Attica, Greece
Laiko General Hospital of Athens
Athens, Attica, Greece
University Hospital of Ioannina
Ioannina, Greece
Hemato-Oncology Clinic Ahmedabad PVT. LTD.
Ahmedabad, Gujarat, India
Nirmal Hospital Pvt. Ltd - Surat
Surat, Gujarat, India
Amrita Institute of Medical Sciences and Research Centre (AIMS)
Kochi, Kerala, India
K J Somaiya Super Specialty Hospital & Research Centre
Mumbai, Maharashtra, India
All India Institute of Medical Sciences, New Delhi
New Delhi, National Capital Territory of Delhi, India
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, India
JK Lon Hospital
Jaipur, Rajasthan, India
Day Hospital Thalassemia and Haemoglobinopathies (DHTE); A.O.U S.Anna
Ferrara, Italy
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, Malaysia
Sarawak General Hospital
Kuching, Sarawak, Malaysia
Hospital Ampang
Ampang, Selangor, Malaysia
Hospital Tunku Ampuan Besar Tuanku Aishah Rohani (HPKK UKM)
Kuala Lumpur, Malaysia
Songklanagarind Hospital, Prince of Songkla University
Hat Yai, Changwat Songkhla, Thailand
Chulalongkorn University
Bangkok, Thailand
Phramongkutklao Hospital
Bangkok, Thailand
Chiang Mai University
Chiang Mai, Thailand
Srinagarind Hospital
Khon Kaen, Thailand
Hacettepe University
Ankara, Turkey (Türkiye)
University College London Hospitals NHS Trust
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom