570 Participants NeededMy employer runs this trial

Fel d 1 Monoclonal Antibodies for Allergic Eye

Recruiting at 1 trial location
CT
Overseen ByClinical Trials Administrator
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Regeneron Pharmaceuticals
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new medicines to determine if they can reduce eye allergy symptoms caused by cat hair or dander. The study examines two medicines, freneslerbart and mevonlerbart, administered alone or together as REGN-2Cat (a combination treatment), and compares them to a placebo. Researchers aim to understand how these medicines affect the body, including any side effects and the duration of their effects. The trial seeks participants who test positive for cat allergies and experience eye-related allergy symptoms. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of potentially effective treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that freneslerbart, mevonlerbart, and REGN-2Cat are being explored as potential treatments for eye allergies caused by cat dander. Although detailed safety information for these treatments isn't widely available yet, their testing in advanced clinical trials indicates they have met safety standards for further research.

Treatments at this stage have typically undergone earlier studies to ensure initial safety for humans. This suggests they have likely demonstrated that any side effects are manageable and not severe for most people. Researchers are testing these treatments to see if they can reduce eye allergy symptoms, examining how the body processes them, and assessing any adverse reactions.

For those interested in joining a trial, it's important to know that these treatments are under careful study to ensure safety. While side effects can occur, clinical trials are designed to monitor and manage them closely.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for allergic eye conditions because they target Fel d 1, a major allergen responsible for cat allergies, in a new way. Unlike traditional treatments like antihistamines and corticosteroids that focus on symptomatic relief, these monoclonal antibodies—Freneslerbart, Mevonlerbart, and REGN-2Cat—aim to neutralize the allergen itself. This potentially offers a more direct and effective approach to reducing allergy symptoms. By specifically targeting the root cause of the allergy, these treatments may provide faster and longer-lasting relief, changing the game for those suffering from cat-induced allergic eye discomfort.

What evidence suggests that this trial's treatments could be effective for allergic eye symptoms?

This trial will evaluate the effectiveness of three treatments for allergic eye reactions caused by cat dander: REGN-2Cat, Freneslerbart, and Mevonlerbart. Research has shown that REGN-2Cat, tested in this trial, may help reduce symptoms like itchy and watery eyes. Freneslerbart and Mevonlerbart, tested in separate arms of this trial, aim to block certain allergens, potentially easing allergic reactions in the eyes. While detailed human data on these drugs is still being gathered, their mechanisms suggest they could effectively reduce eye allergy symptoms.678910

Who Is on the Research Team?

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults and children (8 years and older) who have allergic eye symptoms caused by cats. Participants must test positive for cat allergy on skin and blood tests.

Inclusion Criteria

I have tested positive for a cat allergy.
I meet the main requirements for this study.
I am in the required age group for this study part.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive freneslerbart, mevonlerbart, or REGN-2Cat to assess efficacy and safety in reducing eye allergy symptoms

12 weeks
Multiple visits including Day 8 and up to Day 85

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Freneslerbart
  • Mevonlerbart
  • REGN-2Cat

Trial Overview

The study is testing two new medicines, freneslerbart and mevonlerbart, given alone or together (called REGN-2Cat), to see if they help with cat allergy-related pink eye compared to a placebo. The drugs are given randomly in different groups.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: REGN-2CatExperimental Treatment1 Intervention
Group II: MevonlerbartExperimental Treatment1 Intervention
Group III: FreneslerbartExperimental Treatment1 Intervention
Group IV: Matching placeboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Citations

Allergic Conjunctivitis Pipeline

It is rarely vision-threatening but can significantly decrease the quality of life for patients. can effectively remove these allergens

Allergic conjunctivitis: The evolution of therapeutic options

Intranasal steroids only have a mild effect on ocular symptoms of allergic conjunctivitis (more on season- al/intermittent than perennial/persistent forms).

Conjunctivitis, Allergic - Drugs, Targets, Patents

Results Among the enrolled patients, a prevalence of nonsensitized cases (56%) emerged. Both sensitized and nonsensitized groups displayed ...

(PDF) Treatment of allergic conjunctivitis with olopatadine

This is a preliminary report on a study aimed at assessing the olopatadine therapy efficacy in resolving the signs and symptoms of allergic conjunctivitis.

Emerging therapies in allergic conjunctivitis and dry eye ...

The goal of this review is to examine the emerging pipeline for noninfectious inflammatory disorders of the anterior surface of the eye - ...

Allergic Conjunctivitis - StatPearls - NCBI Bookshelf - NIH

Eye rubbing should be discouraged because mechanical stimulation can trigger mast cell degranulation and worsen symptoms. Frequent application ...

NCT07675811 | A Study to Evaluate the Efficacy and ...

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 ...

A Study to Evaluate the Efficacy and Safety of Fel d 1 ...

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 ...

Freneslerbart - Drug Targets, Indications, Patents

Due to its small size and stability, it easily becomes airborne and adheres to surfaces, posing a persistent problem for allergic individuals.

ALLERGIC CONJUNCTIVITIS

Olopatadine eye drops are a safe and effective treatment modality, but it is limited in reducing ocular itching. Steroids. • These are the most potent and ...