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)
Positive SPT to birch allergen extract
Positive allergen specific Immunoglobulin E (sIgE) tests for birch and Bet v 1
Positive CAC 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
Parallel
REGN5713
DrugAdministered per protocol
REGN5715
DrugAdministered per protocol
Placebo
DrugAdministered per protocol
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
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
Ocular itch score in participants receiving REGN5713-5715 compared to placebo
Conjunctival redness score in participants receiving REGN5713-5715 compared to placebo
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
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
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