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Completed

NCT Number: NCT06602739

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kingston Health Sciences Centre, Kingston, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

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 response to birch allergen challenge

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

    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

Secondary outcomes

  1. Conjunctival redness score in response to birch allergen challenge

    Time frame: At Day 8 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 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments

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

    Time frame: Baseline and at Day 8

  3. Tearing score in response to birch allergen challenge

    Time frame: At Day 8 post-CAC

    Assessed using the Ora Calibra® Conjunctival Allergen Challenge Tearing Scale, a 0-4 scale where 0 = none and 4 = very severe, 1 unit increments

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

    Time frame: At Day 8 post-CAC

    TOSS is a summed score of ocular itch score (graded 0 = none to 4 = incapacitating itch), conjunctival redness score (graded 0 = none to 4 = extremely severe), and tearing score (graded 0 = none to 4 = very severe) for a total range from 0 to 12, where higher scores indicate worse responses.

  5. Total redness score in response to birch allergen challenge

    Time frame: At Day 8 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)

  6. Ciliary redness score in response to birch allergen challenge

    Time frame: At Day 8 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 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments

  7. Episcleral redness score

    Time frame: At Day 8 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 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments

  8. Change in birch tSPT

    Time frame: Baseline and Day 8

    AUC of the mean wheal diameters

  9. Change in birch tSPT

    Time frame: Baseline and Day 113

    AUC of the mean wheal diameters

  10. Percent change in birch tSPT

    Time frame: Baseline and Day 113

    AUC of the mean wheal diameters

  11. Change in oak tSPT

    Time frame: Baseline and Day 8

    AUC of the mean wheal diameter

  12. Percent change in oak tSPT

    Time frame: Baseline and Day 8

    AUC of the mean wheal diameters

  13. Incidence of Treatment-emergent adverse event (TEAEs)

    Time frame: Up to Day 113

  14. Incidence of serious TEAEs

    Time frame: Up to Day 113

  15. Incidence of Adverse Events of Special Interest (AESIs)

    Time frame: Up to Day 113

  16. Total REGN5713 concentrations in serum over time

    Time frame: Up to Day 113

  17. Total REGN5715 concentrations in serum over time

    Time frame: Up to Day 113

  18. Incidence of Anti-drug antibody (ADAs) to REGN5713

    Time frame: Up to Day 113

  19. Titers of ADAs to REGN5713

    Time frame: Up to Day 113

  20. Incidence of ADAs to REGN5715

    Time frame: Up to Day 113

  21. Titers of ADAs to REGN5715

    Time frame: Up to Day 113

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-Masked, Placebo-Controlled Study to Assess the Efficacy and Safety of REGN5713-5715 to Reduce Signs and Symptoms of Allergic Conjunctivitis in Participants With Birch Pollen Allergy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Apr 21, 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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