Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369467
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-04-11
Brief Title:
Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E IgE-Mediated Food Allergy
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Phase 1 Dose-Escalation Study in Adults With Severe IgE-Mediated Food Allergy to Assess the Safety Tolerability and Pharmacodynamic Effects of Short-Term Linvoseltamab Treatment a BCMAxCD3 Bispecific Antibody to Induce T-Cell Killing of IgE Producing Plasma Cells on Top of Chronic Dupilumab Treatment to Prevent the Formation of New IgE Producing Plasma Cells
Status:
RECRUITING
Status Verified Date:
2024-06
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 linvoseltamab when combined with another drug called dupilumab The study is focused on patients who have IgE-mediated food allergy If the patient has an allergy the immune system overreacts to an allergen eg certain foods such as peanuts milk shellfish by producing antibodies called IgE IgE antibodies are released by cells such as plasma cells These antibodies and allergens bind to other cells that release chemicals causing an allergic reaction The aim of the study is to see how safe and tolerable linvoseltamab is when combined with dupilumab
The study is looking at several other research questions including
What side effects may happen from taking the study drugs
Whether linvoseltamab when combined with dupilumab has an effect on other types of antibodies in the blood at different times
How much study drugs is in the blood at different times
The study is looking at several other research questions including
What side effects may happen from taking the study drugs
Whether linvoseltamab when combined with dupilumab has an effect on other types of antibodies in the blood at different times
How much study drugs is in the blood at different times
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 |
|---|---|---|---|
| 2024-511032-27-00 | REGISTRY | EU CT Number | None |