RecruitingPhase 2NCT06421636

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


Sponsor

Regeneron Pharmaceuticals

Enrollment

95 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called REGN7999 for people with non-transfusion dependent beta-thalassemia (ntdt). The study is currently recruiting participants at 26 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGREGN7999

Administered subcutaneous (SC)

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT06421636