Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-29 @ 11:51 PM
Study NCT ID:
NCT07309432
Status:
RECRUITING
Last Update Posted:
2026-02-10
First Post:
2025-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescents and Adults With Birch Pollen Allergy
Sponsor:
Regeneron Pharmaceuticals
Organization:
Study Overview
Official Title:
A Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Bet v 1 Monoclonal Antibodies in Participants With Allergic Conjunctivitis Due to Birch Pollen Allergy
Status:
RECRUITING
Status Verified Date:
2026-02
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 2 experimental drugs, REGN5713 and REGN5715. The study drugs will be either of these drugs given alone (either REGN5713 or REGN5715) or given together (REGN5713 and REGN5715) 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 drugs are at lowering eye allergy signs and symptoms compared with placebo.
The study will also evaluate whether the combination (REGN5713-5715) has different effectiveness than REGN5713 or REGN5715 alone.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drugs
* How much of the study drugs is in the blood at different times
* Whether the body makes antibodies against the study drugs (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 drugs are at lowering eye allergy signs and symptoms compared with placebo.
The study will also evaluate whether the combination (REGN5713-5715) has different effectiveness than REGN5713 or REGN5715 alone.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drugs
* How much of the study drugs is in the blood at different times
* Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: