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NCT Number: NCT07309432

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

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)

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Andover Eye Associates, Andover, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • 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

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Treatment and study plan

REGN5713

Drug

Administered per protocol

Other names: Bremzalerbart

REGN5715

Drug

Administered per protocol

Other names: Atisnolerbart

Placebo

Drug

Administered per protocol

Primary outcomes

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

    Time frame: At Day 8 post-Conjunctival Allergen Challenge (CAC)

    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

Secondary outcomes

  1. 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

    Time frame: Baseline to Day 8 post-CAC

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

    Time frame: At Day 57 post-CAC

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

    Time frame: At Day 8 and Day 57 post-CAC

    Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival [conjunctival redness scale] ciliary [ciliary redness scale], episcleral [episcleral redness scale] vessel beds), a 0 to 4 scale, where 0 = none and 4 = extremely severe, 0.5 unit increments

  4. 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

    Time frame: Baseline to Day 8 post-CAC

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

    Time frame: At Day 8 post-CAC

    The TNSS ranges from 0 to 12 and is based on assessment of 4 nasal symptoms graded on a verbal rating scale ranging from 0 (none) to 3 (severe) for nasal congestion, nasal itching, rhinorrhea, and sneezing.

  6. Ocular itch score in participants receiving REGN5715 compared to placebo

    Time frame: At Day 8 and Day 57 post-CAC

  7. 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 REGN5715 compared to placebo

    Time frame: Baseline to Day 8 post-CAC

  8. Conjunctival redness score in participants receiving REGN5715 compared to placebo

    Time frame: At Day 8 post-CAC

  9. Achievement of at least a 1-point reduction in conjunctival redness score in for at least 2 out of 3 post-CAC time points participants receiving REGN5715 compared to placebo

    Time frame: Baseline to Day 8 post-CAC

  10. Ocular itch score in participants receiving REGN5713 compared to placebo

    Time frame: At Day 8 and Day 57 post-CAC

  11. 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 compared to placebo

    Time frame: Baseline to Day 8 post-CAC

  12. Conjunctival redness score in participants receiving REGN5713 compared to placebo

    Time frame: At Day 8 post-CAC

  13. 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 compared to placebo

    Time frame: Baseline to Day 8 post-CAC

  14. Percent change in birch titrated Skin Prick Test (tSPT) in participants receiving REGN5713-5715 compared to placebo

    Time frame: Baseline and at Day 8 post-CAC

    Area Under the Curve (AUC) of the mean wheal diameters

  15. Ocular itch score in participants receiving REGN5713-5715 compared to REGN5713

    Time frame: Baseline to Day 8 post-CAC

  16. Ocular itch score in participants receiving REGN5713-5715 compared to REGN5715

    Time frame: Baseline to Day 8 post-CAC

  17. Achievements of different response thresholds for the ocular itch score among participants receiving REGN5713-5715, REGN5713, REGN5715 or placebo

    Time frame: Baseline to Day 8 post-CAC

  18. 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

    Time frame: Baseline to Day 57 post-CAC

  19. 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

    Time frame: Baseline to Day 57 post-CAC

  20. Ciliary redness score in participants receiving REGN5713-5715 compared to placebo

    Time frame: At Day 8 and Day 57 post-CAC

    Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival [conjunctival redness scale] ciliary [ciliary redness scale], episcleral [episcleral redness scale] vessel beds), a 0 to 4 scale, where 0 = none and 4 = extremely severe, 0.5 unit increments

  21. Episcleral redness score in participants receiving REGN5713-5715 compared to placebo

    Time frame: At Day 8 and Day 57 post-CAC

    Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival [conjunctival redness scale] ciliary [ciliary redness scale], episcleral [episcleral redness scale] vessel beds), a 0 to 4 scale, where 0 = none and 4 = extremely severe, 0.5 unit increments

  22. Total redness score in participants receiving REGN5713-5715 compared to placebo

    Time frame: At Day 8 and Day 57 post-CAC

    The total redness score is calculated for CAC: range 0 to 12, where higher scores indicate worse responses (calculated as a sum of the bilateral averages for conjunctival redness score, graded 0 = none to 4 = extremely severe + ciliary redness score, graded 0 = none and 4 = extremely severe + episcleral redness score, graded 0 = none and 4 = extremely severe)

  23. Percent change in birch tSPT in participants receiving REGN5713-5715 compared to placebo

    Time frame: Baseline and at Day 57 post-CAC

  24. Percent change in birch tSPT in participants receiving REGN5715 compared to placebo

    Time frame: Baseline, at Day 8 and at Day 57 post-CAC

  25. Percent change in birch tSPT in participants receiving REGN5713 compared to placebo

    Time frame: Baseline, at Day 8 and at Day 57 post-CAC

  26. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to Day 113

  27. Severity of TEAEs

    Time frame: Up to Day 113

  28. Occurrence of Treatment Emergent-Serious Adverse Events (TE-SAEs)

    Time frame: Up to Day 113

  29. Concentrations of total REGN5713 is serum over time

    Time frame: Up to Day 113

  30. Concentrations of total REGN5715 is serum over time

    Time frame: Up to Day 113

  31. Occurrence of Anti-Drug Antibodies (ADA) responses to REGN5713

    Time frame: Up to Day 113

  32. Magnitude of ADA to REGN5713

    Time frame: Up to Day 113

  33. Occurrence of ADA responses to REGN5715

    Time frame: Up to Day 113

  34. Magnitude of ADA to REGN5715

    Time frame: Up to Day 113

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 30, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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