Cat-allergy eye allergy treatment with REGN-2Cat and study drugs in adults and kids
Official title: A Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Participants With Allergic Conjunctivitis Due to Cat Allergy
Run by Regeneron Pharmaceuticals · NCT07675811 · Data updated 2026-11-12
This trial tests fel d 1 monoclonal antibodies (freneslerbart and mevonlerbart) alone or together to see if they reduce cat‑induced allergic conjunctivitis symptoms compared with placebo in adults and children.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 8 Years and up |
| Sex | All |
| Enrollment | 570 (estimated) |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Locations | 2 sites (Long Beach, California and 1 other locations) |
| Status | Recruiting |
| Started | July 31, 2026 |
| Main results expected | May 31, 2029 |
| Study ends | September 20, 2029 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07675811 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18+ and children 8–17 (with adult participation), who have cat-induced allergic conjunctivitis and positive cat allergen tests.
✕Probably not a fit
Participants with non-cat ocular allergies or those who do not respond to the study drugs may not experience symptom relief.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 interventional study evaluates the safety and efficacy of three investigational antibodies—freneslerbart, mevonlerbart, and REGN-2Cat (the combination)—in adults and children with allergic conjunctivitis caused by cat exposure. Participants may receive one of the study drugs alone, in combination, or placebo, with attention to pharmacokinetics and antibody formation against the drugs. The trial assesses symptom changes in the eye, safety signals, and how long drug effects last during and after treatment. Eligibility requires cat allergen sensitivity, positive cat-specific IgE, and other criteria to minimize confounding factors. Locations include sites in California and Massachusetts under Regeneron sponsorship.
Why it matters
Potential benefit: If successful, participants could experience reduced eye allergy symptoms from cat exposure and access to new preventive eye allergy treatments.
How similar studies have gone: Prior studies of monoclonal antibodies for ocular allergies have shown potential benefit in related allergic conditions, but this exact REGN-2Cat approach is novel for cat-induced conjunctivitis.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Ark Clinical Research, LLC
Long Beach, California, United States Recruiting -
Andover Eye Associates
Andover, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.