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

Purpose

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

Condition

  • Allergic Conjunctivitis

Eligibility

Eligible Ages
Over 8 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
REGN-2Cat 		Part A and B
  • Drug: REGN-2Cat
    Administered per the protocol
    Other names:
    • REGN1908-REGN1909
Experimental
Freneslerbart 		Part A and B
  • Drug: Freneslerbart
    Administered per the protocol
    Other names:
    • REGN1908
Experimental
Mevonlerbart 		Part A
  • Drug: Mevonlerbart
    Administered per the protocol
    Other names:
    • REGN1909
Placebo Comparator
Matching placebo 		Part A and B
  • Drug: Placebo
    Administered per the protocol

Recruiting Locations

Andover Eye Associates
Andover, Massachusetts 01810

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com