A Randomized, Double-masked, Placebo-controlled Study to Assess the Efficacy and Safety of REGN1908-1909 to Reduce Signs and Symptoms of Allergic Conjunctivitis in Participants With Cat Allergy

Status: Completed
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Documented or participant-reported history of moderate to severe cat allergy for at least 2 years with bothersome ocular symptoms being near cat(s)

• Positive SPT with cat allergen extract (mean wheal diameter at least 5 mm greater than the negative control) at screening visit 1

• Positive Allergen-specific Immunoglobulin E (sIgE) tests for cat allergen and Fel d 1 (both ≥0.7 kUa/L) at screening visit 1

• Must be able to complete the screening CACs to confirm moderate to severe cat allergen-induced allergic conjunctivitis as described in the protocol

• 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

Locations
United States
Massachusetts
Andover Eye Associates
Andover
Other Locations
Canada
Kingston Health Sciences Centre
Kingston
Red Maple Trials Inc.
Ottawa
Clinique de Specialisee en Allergie de la Capitale
Québec
Time Frame
Start Date: 2024-11-06
Completion Date: 2025-08-02
Participants
Target number of participants: 64
Treatments
Experimental: REGN1908-1909
Placebo_comparator: Placebo
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov

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