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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 is a Phase 1 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 17 participants.
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 \[ADA\])
Interventions
- DRUG REGN7257
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2021-01-13 |
| Est. Completion | 2024-10-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04409080
The ClinicalTrials.gov registry entry for NCT04409080 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which REGN7257 is the first listed.
NCT04409080 reports 0 study locations.
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.
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