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

Last updated: May 20, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

3

Condition

Allergy (Pediatric)

Allergies & Asthma

Eye Disorders/infections

Treatment

REGN5715

Placebo

REGN5713

Clinical Study ID

NCT06602739
R5713-5715-ALG-2415
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Documented or participant-reported history of moderate to severe birch pollenallergy for at least 2 years with bothersome ocular symptoms during the birch season

  2. Positive SPT to birch allergen extract, as described in the protocol

  3. Positive allergen specific immunoglobulin E (sIgE) tests for birch and Bet v 1 (≥0.7kUa/L) at screening visit 1

  4. Must be able to complete birch screening CACs and meet the criteria, as described inthe protocol

Exclusion

Key Exclusion Criteria:

  1. Participation in a prior clinical study and received either REGN5713-5714-5715,REGN5713-5715, or REGN5715 antibodies, as described in the protocol

  2. Inability to complete or termination of the screening or confirmatory CACs due to asafety concern (eg, anaphylaxis) per Principal Investigator (PI) judgement

  3. Significant and/or severe allergies causing symptoms that are expected to coincideor potentially interfere with the study CAC assessments, as assessed by theinvestigator, as described in the protocol

  4. Persistent chronic or recurring acute infection requiring treatment with systemicantibiotics, antivirals, or antifungals, or any untreated respiratory infectionswithin 4 weeks prior to screening visit 1, as described in the protocol

  5. The presence of an active ocular infection (bacterial, viral, or fungal) ordiagnosis by a physician within 30 days prior to screening visit 1, as described inthe protocol

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 54
Treatment Group(s): 3
Primary Treatment: REGN5715
Phase: 3
Study Start date:
November 19, 2024
Estimated Completion Date:
July 28, 2025

Connect with a study center

  • Kingston Health Sciences Centre

    Kingston, Ontario K7L 2V7
    Canada

    Site Not Available

  • Clinique de Specialisee en Allergie de la Capitale

    Quebec, G1V 4W2
    Canada

    Site Not Available

  • Andover Eye Associates

    Andover, Massachusetts 01810
    United States

    Site Not Available

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