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

Regeneron Pharmaceuticals54 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Allergic Conjunctivitis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. 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 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 (≥0.7 kUa/L) at screening visit 1 4. Must be able to complete birch screening CACs and meet the criteria, as described in the protocol 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 a safety concern (eg, anaphylaxis) per Principal Investigator (PI) judgement 3. 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 4. 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 5. 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.

Locations (3)

Andover Eye Associates

Andover, Massachusetts, United States

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Clinique de Specialisee en Allergie de la Capitale

Québec, Canada

Outcomes

Primary Outcomes

Ocular itch score in response to birch allergen challenge

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

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

Secondary Outcomes

Conjunctival redness score in response to birch allergen challenge

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

Time frame: At Day 8 post-CAC

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

Time frame: Baseline and at Day 8

Tearing score in response to birch allergen challenge

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

Time frame: At Day 8 post-CAC

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

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.

Time frame: At Day 8 post-CAC

Total redness score in response to birch allergen challenge

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 post-CAC

Ciliary redness score in response to birch allergen challenge

Time frame: At Day 8 post-CAC

Episcleral redness score

Time frame: At Day 8 post-CAC

Change in birch tSPT

AUC of the mean wheal diameters

Time frame: Baseline and Day 8

Change in birch tSPT

AUC of the mean wheal diameters

Time frame: Baseline and Day 113

Percent change in birch tSPT

AUC of the mean wheal diameters

Time frame: Baseline and Day 113

Change in oak tSPT

AUC of the mean wheal diameter

Time frame: Baseline and Day 8

Percent change in oak tSPT

AUC of the mean wheal diameters

Time frame: Baseline and Day 8

Incidence of Treatment-emergent adverse event (TEAEs)

Time frame: Up to Day 113

Incidence of serious TEAEs

Time frame: Up to Day 113

Incidence of Adverse Events of Special Interest (AESIs)

Time frame: Up to Day 113

Total REGN5713 concentrations in serum over time

Time frame: Up to Day 113

Total REGN5715 concentrations in serum over time

Time frame: Up to Day 113

Incidence of Anti-drug antibody (ADAs) to REGN5713

Time frame: Up to Day 113

Titers of ADAs to REGN5713

Time frame: Up to Day 113

Incidence of ADAs to REGN5715

Time frame: Up to Day 113

Titers of ADAs to REGN5715

Time frame: Up to Day 113