Recruiting
Phase 3

Freneslerbart & Mevonlerbart

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07675811

Conditions

Allergic Conjunctivitis

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

Interventions

REGN-2Cat

Freneslerbart

Mevonlerbart

Placebo

Study Details

Brief 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

Conditions

Allergic Conjunctivitis

Study ID

NCT07675811

Start date

Jul 31, 2026

Status verified date

Aug, 2026

Completion date

Sep 20, 2029

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

570 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: REGN-2Cat

Part A and B

experimental: Freneslerbart

Part A and B

experimental: Mevonlerbart

Part A

placebo comparator: Matching placebo

Part A and B

Interventions

REGN-2Cat

Administered per the protocol

Freneslerbart

Administered per the protocol

Mevonlerbart

Administered per the protocol

Placebo

Administered per the protocol

Primary outcome measure

  • Ocular itch score in participants receiving REGN-2Cat as compared to placebo [ Time Frame: At day 8, post-Conjunctival Allergen Challenge (CAC) ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Andover Eye Associates

Recruiting

Andover, Massachusetts, United States, 01810

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Cat allergy
  • Eye allergy
  • Cat-induced eye allergy
  • Ocular allergy signs/symptoms
  • Allergic conjunctivitis signs/symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-08-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.