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NCT06421636 · ClinicalTrials.gov registry record · Phase 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 study of Non-Transfusion Dependent Beta-Thalassemia (NTDT), sponsored by Regeneron Pharmaceuticals.

Recruiting
Registry status
Phase 2
Development phase
95
Enrollment target
20
Study locations

NCT06421636: Recruiting Phase 2 study of Non-Transfusion Dependent Beta-Thalassemia (NTDT), sponsored by Regeneron Pharmaceuticals.

NCT06421636 is a Phase 2 study of Non-Transfusion Dependent Beta-Thalassemia (NTDT) that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 95 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06421636, a Phase 2 study of Non-Transfusion Dependent Beta-Thalassemia (NTDT), is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.

RECRUITING
Registry status
Phase 2
Development phase
95 participants
Enrollment target
20
Study locations

Study 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)

Interventions

  • DRUG Placebo
  • DRUG REGN7999

Study Locations (20)

Other

  • K Eristavi National Center of Experimental and Clinical Surgery - Tbilisi
  • Medinvest Institute of Hematology and Transfusiology Limited - Tbilisi
  • University Hospital of Ioannina - Ioannina
  • Day Hospital Thalassemia and Haemoglobinopathies (DHTE); A.O.U S.Anna - Ferrara
  • Hospital Tunku Ampuan Besar Tuanku Aishah Rohani (HPKK UKM) - Kuala Lumpur
  • Chulalongkorn University - Bangkok

Attica

  • Children's Hospital Agia Sophia - Athens
  • Laiko General Hospital of Athens - Athens

Gujarat

  • Hemato-Oncology Clinic Ahmedabad PVT. LTD. - Ahmedabad
  • Nirmal Hospital Pvt. Ltd - Surat - Surat

National Capital Territory of Delhi

  • All India Institute of Medical Sciences, New Delhi - New Delhi
  • Indraprastha Apollo Hospitals - New Delhi

New York

  • Weill Cornell Medicine - New York

Kerala

  • Amrita Institute of Medical Sciences and Research Centre (AIMS) - Kochi

Maharashtra

  • K J Somaiya Super Specialty Hospital & Research Centre - Mumbai

Rajasthan

  • JK Lon Hospital - Jaipur

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2024-09-30
Est. Completion 2028-01-24
Phase Phase 2
Regeneron Pharmaceuticals

280 total trials

What NCT06421636 shows while recruiting

NCT06421636 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).

The record links to 1 condition, with Non-Transfusion Dependent Beta-Thalassemia (NTDT) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06421636 names 20 study sites across 12 states, led by Other, Attica, Gujarat.

Frequently Asked Questions

What is clinical trial NCT06421636 about?

NCT06421636 is a clinical study titled "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". 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, ...

What is the current status of trial NCT06421636?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2024-09-30. Estimated completion is 2028-01-24.

What conditions does trial NCT06421636 study?

This clinical trial studies the following conditions: Non-Transfusion Dependent Beta-Thalassemia (NTDT).

What interventions are being tested in trial NCT06421636?

The interventions under investigation include: Placebo (DRUG), REGN7999 (DRUG).

Who is sponsoring clinical trial NCT06421636?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06421636 being conducted?

This trial has 20 study locations across New York, Attica, Gujarat, Kerala, Maharashtra. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06421636's enrollment target sits among peer trials

95 759th of 2000 higher than 1,238 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06421636, the US trial registry maintained by the National Library of Medicine. NCT06421636 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.