Ignite Creation Date:
2024-05-06 @ 2:44 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04409080
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2020-05-26
Brief Title:
REGN7257 in Adult Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive Therapy
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Phase 12 Study of REGN7257 Anti-Interleukin 2 Receptor Subunit Gamma IL2RG Monoclonal Antibody in Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive Therapy
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-002031-29 | EUDRACT_NUMBER | None | None |
| 2023-508601-24-00 | OTHER | EU CT Number | None |