A Randomized, Double-Masked, Placebo-Controlled Study to Assess the Efficacy and Safety of REGN5713-5715 to Reduce Signs and Symptoms of Allergic Conjunctivitis in Participants With Birch Pollen Allergy

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

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).

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

• 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

• Positive SPT to birch allergen extract, as described in the protocol

• Positive allergen specific immunoglobulin E (sIgE) tests for birch and Bet v 1 (≥0.7 kUa/L) at screening visit 1

• Must be able to complete birch screening CACs and meet the criteria, as described in the protocol

Locations
United States
Massachusetts
Andover Eye Associates
Andover
Other Locations
Canada
Kingston Health Sciences Centre
Kingston
Clinique de Specialisee en Allergie de la Capitale
Québec
Time Frame
Start Date: 2024-11-19
Completion Date: 2025-08-02
Participants
Target number of participants: 54
Treatments
Experimental: REGN5713-5715
Participants will be randomized 1:1
Placebo_comparator: Placebo
Participants will be randomized 1:1
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov

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