A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy

NCT07675811 · tracked via the Priya Life Science USA tracker

Sponsor

Regeneron Pharmaceuticals

Phase

Phase 3

Started

2026-07-31

Last updated

2026-08-12

Condition(s) studied

Allergic Conjunctivitis

Investigational drug(s) / intervention(s)

REGN-2CatFreneslerbartMevonlerbartPlacebo

REGN-2Cat: Administered per the protocol

Freneslerbart: Administered per the protocol

Mevonlerbart: Administered per the protocol

Placebo: Administered per the protocol

Study summary

This study is researching two experimental medicines, freneslerbart and mevonlerbart. Freneslerbart and mevonlerbart can be given alone or together. When given together, the medicine is called "REGN-2Cat". These medicines are also known as the "study drugs".

The aim of the study is to see what side effects freneslerbart, mevonlerbart, and REGN-2Cat may have and if they help reduce eye allergy symptoms caused by cat hair/dander compared with a placebo.

The study is looking at several other research questions, including:

* 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)
* How long the study drug effect lasts

Eligibility

Sex

ALL

Min age

8 Years

Max age

—

Healthy volunteers

Key Inclusion Criteria: 1. Part A: adult participants aged 18 years and older. For part B: pediatric participants ≥8 years and \<18 years, and adult participants aged 18 years and older. 2. Positive SPT to cat allergen extract 3. Positive specific Immunoglobulin E (sIgE) tests for cat and Fel d 1 4. Positive CAC criteria Key Exclusion Criteria: 1. Significant and/or severe environmental allergies causing symptoms (eg, ocular itching, ocular redness, etc) outside of the challenge setting that are expected to coincide or may interfere with study assessments 2. Presence of any ophthalmic disease/ abnormality/ condition that may interfere with study assessments, affect the study outcomes or participant safety 3. A clinical history of asthma with treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment as defined in the protocol Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Primary outcome measure(s)

Ocular itch score in participants receiving REGN-2Cat as compared to placebo — At day 8, post-Conjunctival Allergen Challenge (CAC)

Trial sites (1)

Facility	City	Region	Status
Andover Eye Associates	Andover	Massachusetts	Recruiting

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Other trials for the same condition

Evaluation of TL-925 for the Treatment of Seasonal Allergic Conjunctivitis Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07675811 on ClinicalTrials.gov ↗ ← All trials in the USA