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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
Led by Regeneron Pharmaceuticals · Updated on 2026-03-18
95
Participants Needed
26
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of non-transfusion dependent beta-thalassemia as defined in the protocol
- Liver iron overload defined by liver iron concentration equal to or greater than 5 mg Fe/g dry weight measured by R2* MRI at screening
- Serum ferritin level equal to or greater than 300 ng/mL as described in the protocol
- Age between 18 and 65 years
You will not qualify if you...
- Hemoglobin level less than or equal to 8 g/dL at screening
- Any red blood cell transfusion within 12 weeks before visit 3
- For Part A: Use of iron chelation therapy within approximately 12 weeks before screening
- For Part B: Any change in iron chelation therapy dose within approximately 12 weeks before screening
- Use of luspatercept or mitapivat within 6 months before screening
- Absolute contraindication to MRI
- Diagnosis of cirrhosis of the liver
- Diagnosis of chronic kidney disease stage 4 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
2
K Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, Georgia, 0159
Actively Recruiting
3
Medinvest Institute of Hematology and Transfusiology Limited
Tbilisi, Georgia, 0160
Actively Recruiting
4
Children's Hospital Agia Sophia
Athens, Attica, Greece, 11521
Actively Recruiting
5
Laiko General Hospital of Athens
Athens, Attica, Greece, 11527
Actively Recruiting
6
University Hospital of Ioannina
Ioannina, Greece, 45110
Actively Recruiting
7
Hemato-Oncology Clinic Ahmedabad PVT. LTD.
Ahmedabad, Gujarat, India, 380009
Actively Recruiting
8
Nirmal Hospital Pvt. Ltd - Surat
Surat, Gujarat, India, 395002
Actively Recruiting
9
Amrita Institute of Medical Sciences and Research Centre (AIMS)
Kochi, Kerala, India, 682041
Actively Recruiting
10
K J Somaiya Super Specialty Hospital & Research Centre
Mumbai, Maharashtra, India, 400022
Actively Recruiting
11
All India Institute of Medical Sciences, New Delhi
New Delhi, National Capital Territory of Delhi, India, 110029
Actively Recruiting
12
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, India, 110048
Actively Recruiting
13
JK Lon Hospital
Jaipur, Rajasthan, India, 302004
Actively Recruiting
14
Day Hospital Thalassemia and Haemoglobinopathies (DHTE); A.O.U S.Anna
Ferrara, Italy, 44124
Actively Recruiting
15
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, Malaysia, 88586
Actively Recruiting
16
Sarawak General Hospital
Kuching, Sarawak, Malaysia, 93586
Actively Recruiting
17
Hospital Ampang
Ampang, Selangor, Malaysia, 68000
Actively Recruiting
18
Hospital Tunku Ampuan Besar Tuanku Aishah Rohani (HPKK UKM)
Kuala Lumpur, Malaysia, 56000
Actively Recruiting
19
Songklanagarind Hospital, Prince of Songkla University
Hat Yai, Changwat Songkhla, Thailand, 90110
Actively Recruiting
20
Chulalongkorn University
Bangkok, Thailand, 10330
Actively Recruiting
21
Phramongkutklao Hospital
Bangkok, Thailand, 10400
Actively Recruiting
22
Chiang Mai University
Chiang Mai, Thailand, 50200
Actively Recruiting
23
Srinagarind Hospital
Khon Kaen, Thailand, 40000
Actively Recruiting
24
Hacettepe University
Ankara, Turkey (Türkiye), 06100
Actively Recruiting
25
University College London Hospitals NHS Trust
London, United Kingdom, NW1 2PG
Actively Recruiting
26
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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