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NCT04409080 · ClinicalTrials.gov registry record · Phase 1

REGN7257 in Adult Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive Therapy

A Phase 1 study, sponsored by Regeneron Pharmaceuticals.

Terminated
Registry status
Phase 1
Development phase
17
Enrollment target

NCT04409080: Clinical Trial Phase 1 study, sponsored by Regeneron Pharmaceuticals.

NCT04409080 is a Phase 1 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04409080, a Phase 1 study, was terminated before completion, sponsored by Regeneron Pharmaceuticals.

TERMINATED
Registry status
Phase 1
Development phase
17 participants
Enrollment target

Study Summary

This study is researching an experimental drug called REGN7257 (called "study drug"). The study is focused on patients who have severe aplastic anemia (SAA), a disease of the bone marrow resulting in an impairment of the production of blood cells. The main purpose of this two-part study (Part A and Part B) is to test how safe and tolerable REGN7257 is in patients with SAA in which other Immunosuppressive therapies (ISTs) have not worked well. The study is looking at several other research questions to better understand the following properties of REGN7257: * Side effects that may be experienced by participants taking REGN7257 * How REGN7257 works in the body * How much REGN7257 is present in blood after dosing * If REGN7257 works to raise levels of certain blood counts after treatment * How quickly REGN7257 works to raise levels of certain blood counts * In patients for whom REGN7257 works to raise levels of certain blood counts after treatment, how many continue to show such a response throughout the study * If REGN7257 works to lower the number of platelet and red blood cell transfusions needed * How REGN7257 changes immune cell counts and composition * How the body reacts to REGN7257 and if it produces proteins that bind to REGN7257 (this would be called the formation of anti-drug antibodies \[ADA\])

Primary Outcome

Part A

Interventions

  • DRUG REGN7257

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2021-01-13
Est. Completion 2024-10-17
Phase Phase 1
Regeneron Pharmaceuticals

280 total trials

Why NCT04409080 stopped before completion

NCT04409080 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 1 intervention - of which REGN7257 is the first listed.

NCT04409080 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04409080 about?

NCT04409080 is a clinical study titled "REGN7257 in Adult Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive Therapy". This study is researching an experimental drug called REGN7257 (called "study drug"). The study is focused on patients who have severe aplastic anemia (SAA), a disease of the bone marrow resulting in an impairment of the production of blood cells. The main purpose of this two-part study (Part A and...

What is the current status of trial NCT04409080?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2021-01-13. Estimated completion is 2024-10-17.

What interventions are being tested in trial NCT04409080?

The interventions under investigation include: REGN7257 (DRUG).

Who is sponsoring clinical trial NCT04409080?

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

How this trial's enrollment target compares

Where NCT04409080's enrollment target sits among peer trials

17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT04409080, the US trial registry maintained by the National Library of Medicine. NCT04409080 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.