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

NCT ID: NCT07309432

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-19

Study Completion Date

2027-06-15

Brief Summary

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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)

Detailed Description

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Conditions

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Allergic Conjunctivitis

Keywords

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Birch Pollen Allergy Ocular allergy symptoms Ocular allergy signs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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REGN5713-5715

Group Type EXPERIMENTAL

REGN5713

Intervention Type DRUG

Administered per protocol

REGN5715

Intervention Type DRUG

Administered per protocol

REGN5713

Group Type EXPERIMENTAL

REGN5713

Intervention Type DRUG

Administered per protocol

REGN5715

Group Type EXPERIMENTAL

REGN5715

Intervention Type DRUG

Administered per protocol

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered per protocol

Interventions

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REGN5713

Administered per protocol

Intervention Type DRUG

REGN5715

Administered per protocol

Intervention Type DRUG

Placebo

Administered per protocol

Intervention Type DRUG

Other Intervention Names

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Bremzalerbart Atisnolerbart

Eligibility Criteria

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Inclusion Criteria

1. Positive SPT to birch allergen extract
2. Positive allergen specific Immunoglobulin E (sIgE) tests for birch and Bet v 1
3. Positive CAC criteria

Exclusion Criteria

1. Significant and/or severe environmental allergies causing symptoms (outside of the challenge setting) that are expected to interfere with study assessments
2. Presence of any ophthalmic disease/abnormality/condition that may interfere with study assessments, affect the study outcomes or negatively impact participant safety
3. A clinical history of asthma with treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment more than twice within prior 12 months or once within 3 months prior to screening visit 1 or has been hospitalized or has attended the Emergency Room/Urgent Care facility for asthma in the 12 months prior to screening
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Central Contacts

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Clinical Trials Administrator

Role: CONTACT

Phone: 844-734-6643

Email: [email protected]

Other Identifiers

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R5713-5715-ALG-2556

Identifier Type: -

Identifier Source: org_study_id