Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602739
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
A Study to Demonstrate the Effect of REGN5713-5715 on Reducing Ocular Allergy Signs and Symptoms in Adult Participants With Birch Pollen Allergy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Masked Placebo-Controlled Study to Assess the Efficacy and Safety of REGN5713-5715 to Reduce Signs and Symptoms of Allergic Conjunctivitis in Participants With Birch Pollen Allergy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is researching 2 experimental drugs REGN5713 and REGN5715 which are called REGN5713-5715 when mixed together called study drugs to reduce eye allergy signs and symptoms due to birch tree pollen allergy
The aim of the study is to see how safe and effective the study drug is at lowering allergic eye signs and symptoms compared with placebo A placebo looks like a treatment but does not contain any real medicine
The study is looking at several other research questions including
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
The aim of the study is to see how safe and effective the study drug is at lowering allergic eye signs and symptoms compared with placebo A placebo looks like a treatment but does not contain any real medicine
The study is looking at several other research questions including
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None