A Study to Demonstrate How Well REGN1908-1909 Works in Reducing Ocular Allergy Signs and Symptoms in Adult Participants With Cat Allergy

Regeneron Pharmaceuticals64 enrolled

Overview

This study is researching 2 experimental drugs, REGN1908 and REGN1909, which are called REGN1908-1909 when mixed together (called "study drug") to reduce eye allergy signs and symptoms from cat 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 cat allergy for at least 2 years with bothersome ocular symptoms being near cat(s) 2. Positive SPT with cat allergen extract (mean wheal diameter at least 5 mm greater than the negative control) at screening visit 1 3. Positive Allergen-specific Immunoglobulin E (sIgE) tests for cat allergen and Fel d 1 (both ≥0.7 kUa/L) at screening visit 1 4. Must be able to complete the screening CACs to confirm moderate to severe cat allergen-induced allergic conjunctivitis as described in the protocol 5. Must not have lived with a cat(s) in the home for the past 3 years and must be willing to have no exposure to cat(s) at home throughout the study duration as described in the protocol Key Exclusion Criteria: 1. Participation in a prior clinical study and received either REGN1908-1909, REGN1908, or REGN1909 antibodies as described in the protocol 2. Inability to complete or termination of the screening or confirmatory CAC (where applicable) due to a safety concern (eg, anaphylaxis), per PI judgement 3. Significant and/or severe allergies, ocular, nasal, or systemic disease causing symptoms (eg, ocular itching, ocular redness, etc) that are expected to coincide or potentially interfere with the study CAC assessments, 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. Presence of ocular conditions associated with acute or chronic vision loss, or any other ophthalmic disease or abnormality that may affect the study outcomes or participant safety, per Principal Investigator (PI) judgement as described in the protocol 6. Uncontrolled asthma or on Global Initiative for Asthma (GINA) steps 4 to 5 as described in the protocol 7. Abnormal lung function as judged by the investigator with Forced expiratory volume in 1 second (FEV1) \<70% of predicted at screening 8. History of cat immunotherapy (eg, subcutaneous immunotherapy or any other route) in the 3 years prior to screening visit 1 9. Ongoing Allergen immunotherapy (AIT) with any allergen other than cat at screening visit 1 as described in the protocol Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Locations (4)

Andover Eye Associates

Andover, Massachusetts, United States

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Red Maple Trials Inc.

Ottawa, Ontario, Canada

Clinique de Specialisee en Allergie de la Capitale

Québec, Canada

Outcomes

Primary Outcomes

Ocular itch score

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

Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival \[conjunctival redness scale\], ciliary \[ciliary redness scale\] and 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 cat titrated Skin prick test (tSPT)

Area under the curve (AUC) of the mean wheal diameters

Time frame: Baseline and day 8

Tearing score

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)

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

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

Time frame: At day 8 post-CAC

Episcleral redness score

Time frame: At day 8 post-CAC

Change in cat tSPT

AUC of the mean wheal diameters

Time frame: Baseline and day 8

Change in cat tSPT

AUC of the mean wheal diameters

Time frame: Baseline and day 113

Percent change in cat tSPT

AUC of the mean wheal diameters

Time frame: Baseline and day 113

Incidence of Treatment-emergent adverse events (TEAEs)

Time frame: Up to Day 113

Severity of TEAEs

Time frame: Up to Day 113

Incidence of serious TEAEs

Time frame: Up to Day 113

Incidence of Adverse event of special interest (AESIs)

Time frame: Up to Day 113

Total REGN1908 concentrations in serum over time

Time frame: Up to Day 113

Total REGN1909 concentrations in serum over time

Time frame: Up to Day 113

Incidence of Anti-drug antibodies (ADAs) to REGN1908

Time frame: Up to Day 113

Titers of ADAs to REGN1908

Time frame: Up to Day 113

Incidence of ADAs to REGN1909

Time frame: Up to Day 113

Titers of ADAs to REGN1909

Time frame: Up to Day 113