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NCT06421636Active, not recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 1 Jul 2026

Brief summary (registry, in English)

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)

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
19 (actual)
First submitted
14 May 2024
Start date
30 Sept 2024
Primary completion date
3 Dec 2026
Lead sponsor
Regeneron Pharmaceuticals
Diseases
Thalassaemia
NCT number
NCT06421636
EU CT number
2023-508604-37-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 19
  • From 30 Sept 2024 to the primary completion date, 3 Dec 2026
  • 29 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • For Part A only: Any Iron Chelation Therapy (ICT) use in approximately 12 weeks prior to screening as described in the protocol
  • For Part B only: If on ICT, any change in ICT dose in approximately 12 weeks prior to screening as described in the protocol
  • Any use of luspatercept or mitapivat in 6 months prior to screening as described in the protocol

Other illness

  • Diagnosis of Chronic kidney disease (CKD) stage 4 or higher
    • Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Lab values

  • Hemoglobin ≤ 8 g/dL at screening

Other

  • Any RBC transfusion within 12 weeks of visit 3
  • Absolute contraindication to MRI
  • Diagnosis of cirrhosis of the liver

Who the study is looking for

  • Clinical diagnosis of NTDT as described in the protocol
  • IOL, defined as LIC ≥ 5 mg Fe/g DW as measured by R2\* MRI at screening
  • Serum ferritin ≥ 300 ng/mL as described in the protocol

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Imperial College Healthcare NHS Trust
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LondonUnited KingdomUnknown status
University College London Hospitals NHS Trust
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LondonUnited KingdomUnknown status
Medinvest Institute of Hematology and Transfusiology Limited
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TbilisiGeorgiaUnknown status
K. Eristavi National Center of Experimental and Clinical Surgery
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TbilisiGeorgiaUnknown status
Laiko General Hospital of Athens
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AthensGreeceCompleted
Nosokomeio Paidon I Agia Sofia
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AthensGreeceCompleted
University General Hospital of Ioannina
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IoanninaGreeceCompleted
Hemato Oncology Clinic Ahmedabad Pvt. Ltd.
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AhmedabadIndiaUnknown status
JK Lon Hospital
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JaipurIndiaUnknown status
Amrita Institute of Medical Sciences and Research Centre (AIMS)
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KochiIndiaUnknown status
K J Somaiya Super Specialty Hospital & Research Centre
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MumbaiIndiaUnknown status
All India Institute of Medical Sciences, New Delhi
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New DelhiIndiaUnknown status
Indraprastha Apollo Hospitals
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New DelhiIndiaUnknown status
Nirmal Hospital Pvt. Ltd - Surat
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SuratIndiaUnknown status
University Hospital Of Ferrara
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FerraraItalyCompleted
Ente Ospedaliero Ospedali Galliera Di Genova
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GenoaItalyCompleted
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
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PalermoItalyCompleted
Ospedale Pediatrico Bambino Gesù
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RomeItalyCompleted
Hospital Ampang
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AmpangMalaysiaUnknown status
Hospital Queen Elizabeth
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Kota KinabaluMalaysiaUnknown status
Hospital Tunku Ampuan Besar Tuanku Aishah Rohani (HPKK UKM)
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Kuala LumpurMalaysiaUnknown status
Sarawak General Hospital
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KuchingMalaysiaUnknown status
Phramongkutklao Hospital
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BangkokThailandUnknown status
Chulalongkorn University
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BangkokThailandUnknown status
Chiang Mai University
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Chiang MaiThailandUnknown status
Songklanagarind Hospital Prince of Songkla University
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Hat YaiThailandUnknown status
Srinagarind Hospital
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Khon KaenThailandUnknown status
Weill Cornell Medicine
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New YorkUnited StatesUnknown status
Hacettepe University
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AnkaraTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.