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 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: R1908-1909-ALG-2582
• Study Type: interventional
• Target: 570
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Ocular itch score in participants receiving REGN-2Cat as compared to placebo

  At day 8, post-Conjunctival Allergen Challenge (CAC)

Secondary Outcomes (35)

• 1. Ocular itch score in participants receiving REGN-2Cat as compared to placebo

  Up to day 85, post-CAC

• 2. Conjunctival redness score in participants receiving REGN-2Cat as compared to placebo

  Up to day 85, post-CAC

• 3. Achievement of at least a 1-point reduction from baseline in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN-2Cat as compared to placebo

  Up to day 85, post-CAC

• 4. Achievement of at least a 1-point reduction from baseline in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN-2Cat as compared to placebo

  Up to day 85, post-CAC

• 5. Percent change from baseline in cat titrated Skin Prick Test (tSPT) in participants receiving REGN-2Cat as compared to placebo

  Up to day 85

Study Arms (4)

REGN-2Cat

EXPERIMENTAL

Part A and B

Drug: REGN-2Cat

Freneslerbart

EXPERIMENTAL

Part A and B

Drug: Freneslerbart

Mevonlerbart

EXPERIMENTAL

Part A

Drug: Mevonlerbart

Matching placebo

PLACEBO COMPARATOR

Part A and B

Drug: Placebo

Interventions

REGN-2Cat DRUG

Administered per the protocol

Also known as: REGN1908-REGN1909

REGN-2Cat

Freneslerbart DRUG

Administered per the protocol

Also known as: REGN1908

Freneslerbart

Mevonlerbart DRUG

Administered per the protocol

Also known as: REGN1909

Mevonlerbart

Placebo DRUG

Administered per the protocol

Matching placebo

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Positive SPT to cat allergen extract
• Positive specific Immunoglobulin E (sIgE) tests for cat and Fel d 1
• Positive CAC criteria

You may not qualify if:

• 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
• Presence of any ophthalmic disease/ abnormality/ condition that may interfere with study assessments, affect the study outcomes or participant safety
• A clinical history of asthma with treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment as defined in the protocol

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: July 27, 2026
• Primary Completion (Estimated): October 16, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf