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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
350
Administered per protocol
Administered per protocol
Administered per protocol
Andover Eye Associates
Andover, Massachusetts, United States
RECRUITINGOcular 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
Time frame: At Day 8 post-Conjunctival Allergen Challenge (CAC)
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
Ocular itch score in participants receiving REGN5713-5715 compared to placebo
Time frame: At Day 57 post-CAC
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
Time frame: At Day 8 and Day 57 post-CAC
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
Total Nasal Symptom Score (TNSS) in participants receiving REGN5713-5715 compared to placebo
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.
Time frame: At Day 8 post-CAC
Ocular itch score in participants receiving REGN5715 compared to placebo
Time frame: At Day 8 and Day 57 post-CAC
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
Conjunctival redness score in participants receiving REGN5715 compared to placebo
Time frame: At Day 8 post-CAC
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
Ocular itch score in participants receiving REGN5713 compared to placebo
Time frame: At Day 8 and Day 57 post-CAC
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
Conjunctival redness score in participants receiving REGN5713 compared to placebo
Time frame: At Day 8 post-CAC
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
Percent change in birch titrated Skin Prick Test (tSPT) in participants receiving REGN5713-5715 compared to placebo
Area Under the Curve (AUC) of the mean wheal diameters
Time frame: Baseline and at Day 8 post-CAC
Ocular itch score in participants receiving REGN5713-5715 compared to REGN5713
Time frame: Baseline to Day 8 post-CAC
Ocular itch score in participants receiving REGN5713-5715 compared to REGN5715
Time frame: Baseline to Day 8 post-CAC
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
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
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
Ciliary 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
Time frame: At Day 8 and Day 57 post-CAC
Episcleral 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
Time frame: At Day 8 and Day 57 post-CAC
Total redness score in participants receiving REGN5713-5715 compared to placebo
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)
Time frame: At Day 8 and Day 57 post-CAC
Percent change in birch tSPT in participants receiving REGN5713-5715 compared to placebo
Time frame: Baseline and at Day 57 post-CAC
Percent change in birch tSPT in participants receiving REGN5715 compared to placebo
Time frame: Baseline, at Day 8 and at Day 57 post-CAC
Percent change in birch tSPT in participants receiving REGN5713 compared to placebo
Time frame: Baseline, at Day 8 and at Day 57 post-CAC
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 113
Severity of TEAEs
Time frame: Up to Day 113
Occurrence of Treatment Emergent-Serious Adverse Events (TE-SAEs)
Time frame: Up to Day 113
Concentrations of total REGN5713 is serum over time
Time frame: Up to Day 113
Concentrations of total REGN5715 is serum over time
Time frame: Up to Day 113
Occurrence of Anti-Drug Antibodies (ADA) responses to REGN5713
Time frame: Up to Day 113
Magnitude of ADA to REGN5713
Time frame: Up to Day 113
Occurrence of ADA responses to REGN5715
Time frame: Up to Day 113
Magnitude of ADA to REGN5715
Time frame: Up to Day 113
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