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
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Non-Transfusion Dependent Beta-Thalassemia (NTDT)
In brief
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)
Key facts
- Study ID
- NCT06421636
- Run by
- Regeneron Pharmaceuticals
- People needed
- 19
- Starts
- 2024-09-30
- Expected to finish
- 2026-12-03
- Last updated by the study team
- 2026-07-01
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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