A Study to Demonstrate the Effect of REGN5713-5715 on Reducing Ocular Allergy Signs and Symptoms in Adult Participants With Birch Pollen Allergy

NCT06602739 | Completed Phase 3 FDA Drug

• 1 other identifier: R5713-5715-ALG-2415
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 3

Brief Summary

This study is researching 2 experimental drugs, REGN5713 and REGN5715, which are called REGN5713-5715 when mixed together (called "study drug") 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).

Conditions

Allergic Conjunctivitis

Keywords

Birch Pollen Allergy; Ocular allergy symptoms; Ocular allergy signs

Outcome Measures

Primary Outcomes (1)

• Ocular itch score in response to birch allergen challenge

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

  At Day 8 post-Conjunctival Allergen Challenge (CAC)

Secondary Outcomes (21)

• Conjunctival redness score in response to birch allergen challenge

  At Day 8 post-CAC

• Percent change in birch titrated Skin Prick Test (tSPT) in response to birch allergen challenge

  Baseline and at Day 8

• Tearing score in response to birch allergen challenge

  At Day 8 post-CAC

• Total ocular symptom score (TOSS) in response to birch allergen challenge

  At Day 8 post-CAC

• Total redness score in response to birch allergen challenge

  At Day 8 post-CAC

Study Arms (2)

REGN5713-5715

EXPERIMENTAL

Participants will be randomized 1:1

Drug: REGN5713; Drug: REGN5715

Placebo

PLACEBO COMPARATOR

Participants will be randomized 1:1

Drug: Placebo

Interventions

REGN5713 DRUG

Administered per protocol

Also known as: Bremzalerbart

REGN5713-5715

REGN5715 DRUG

Administered per protocol

Also known as: Atisnolerbart

REGN5713-5715

Placebo DRUG

Administered per protocol

Placebo

Eligibility Criteria

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

You may qualify if:

• Documented or participant-reported history of moderate to severe birch pollen allergy for at least 2 years with bothersome ocular symptoms during the birch season
• Positive SPT to birch allergen extract, as described in the protocol
• Positive allergen specific immunoglobulin E (sIgE) tests for birch and Bet v 1 (≥0.7 kUa/L) at screening visit 1
• Must be able to complete birch screening CACs and meet the criteria, as described in the protocol

You may not qualify if:

• Participation in a prior clinical study and received either REGN5713-5714-5715, REGN5713-5715, or REGN5715 antibodies, as described in the protocol
• Inability to complete or termination of the screening or confirmatory CACs due to a safety concern (eg, anaphylaxis) per Principal Investigator (PI) judgement
• Significant and/or severe allergies causing symptoms that are expected to coincide or potentially interfere with the study CAC assessments, as assessed by the investigator, as described in the protocol
• Persistent chronic or recurring acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening visit 1, as described in the protocol
• The presence of an active ocular infection (bacterial, viral, or fungal) or diagnosis by a physician within 30 days prior to screening visit 1, as described in the protocol

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (3)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Clinique de Specialisee en Allergie de la Capitale

Québec, G1V 4W2, Canada

Location

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

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: September 17, 2024
• First Posted: September 19, 2024
• Study Start: November 19, 2024
• Primary Completion: April 23, 2025
• Study Completion: August 2, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

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 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); CA (2)