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RECRUITING
NCT07309432
PHASE3

Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescents and Adults With Birch Pollen Allergy

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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)

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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2026-01-10

Completion Date

2027-06-15

Last Updated

2026-02-10

Healthy Volunteers

No

Interventions

DRUG

REGN5713

Administered per protocol

DRUG

REGN5715

Administered per protocol

DRUG

Placebo

Administered per protocol

Locations (1)

Andover Eye Associates

Andover, Massachusetts, United States