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

NCT07309432 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: R5713-5715-ALG-2556
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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)

Conditions

Allergic Conjunctivitis

Keywords

Birch Pollen Allergy; Ocular allergy symptoms; Ocular allergy signs

Outcome Measures

Primary Outcomes (1)

• Ocular itch score in participants receiving REGN5713-5715 compared to placebo

  Assessed using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale, a 0-4 scale where 0 = none and 4= incapacitating itch, 0.5 unit increments

  At Day 8 post-Conjunctival Allergen Challenge (CAC)

Secondary Outcomes (34)

• Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo

  Baseline to Day 8 post-CAC

• Ocular itch score in participants receiving REGN5713-5715 compared to placebo

  At Day 57 post-CAC

• Conjunctival redness score in participants receiving REGN5713-5715 compared to placebo

  At Day 8 and Day 57 post-CAC

• Achievement of at least a 1-point reduction in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo

  Baseline to Day 8 post-CAC

• Total Nasal Symptom Score (TNSS) in participants receiving REGN5713-5715 compared to placebo

  At Day 8 post-CAC

Study Arms (4)

REGN5713-5715

EXPERIMENTAL

Drug: REGN5713; Drug: REGN5715

REGN5713

EXPERIMENTAL

Drug: REGN5713

REGN5715

EXPERIMENTAL

Drug: REGN5715

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

REGN5713 DRUG

Administered per protocol

Also known as: Bremzalerbart

REGN5713; REGN5713-5715

REGN5715 DRUG

Administered per protocol

Also known as: Atisnolerbart

REGN5713-5715; REGN5715

Placebo DRUG

Administered per protocol

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Significant and/or severe environmental allergies causing symptoms (outside of the challenge setting) that are expected to interfere with study assessments
• Presence of any ophthalmic disease/abnormality/condition that may interfere with study assessments, affect the study outcomes or negatively impact participant safety
• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

RECRUITING

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 30, 2025
• Study Start: January 10, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (1)