350 Participants Needed

REGN5713 + REGN5715 for Allergic Eye

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 two experimental drugs, REGN5713 and REGN5715, to determine their effectiveness in reducing eye allergy symptoms caused by birch tree pollen. Researchers aim to evaluate the efficacy of these drugs when used alone or together, comparing them to a placebo (a treatment with no active drug). They also examine possible side effects and the body's response to the drugs. Individuals with a known birch tree pollen allergy who experience eye symptoms might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that the combination of REGN5713 and REGN5715 is generally safe for people. In earlier studies, participants tolerated these drugs well, with most experiencing no serious side effects.

Other studies tested REGN5715 alone and found it safe and effective in relieving allergy symptoms. Similarly, REGN5713 reduced symptoms without major safety issues.

Both drugs, whether used alone or together, aim to reduce eye allergy symptoms like itching and redness caused by birch tree pollen. These trials provide a positive outlook on the safety of these treatments for potential participants.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about REGN5713 and REGN5715 as treatments for allergic eye conditions because they offer a novel approach compared to standard options like antihistamines and corticosteroids. Unlike these traditional treatments, which generally focus on alleviating symptoms, REGN5713 and REGN5715 are designed to target specific pathways involved in the allergic response. This new mechanism of action could potentially provide more effective and longer-lasting relief. Additionally, the possibility of using these treatments individually or in combination offers flexibility in addressing varying severities of allergic eye conditions.

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

Research has shown that the combination of REGN5713 and REGN5715 effectively reduces eye allergy symptoms caused by birch pollen. These drugs block BetV1, a protein in birch pollen that triggers allergies. In previous studies, patients experienced a 52% reduction in itchiness and a 39% decrease in eye redness. In this trial, participants may receive REGN5713 alone, REGN5715 alone, or the combination of both. These findings suggest that REGN5713 and REGN5715 are promising options for managing allergic eye symptoms, whether used alone or together.14678

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 adolescents and adults with birch pollen allergy who have specific positive tests for this allergy. They must show allergic eye symptoms when exposed to birch pollen. People cannot join if they don't meet the required test criteria.

Inclusion Criteria

I am allergic to birch.
I am allergic to birch pollen, confirmed by tests.
I have a positive calcium score.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive REGN5713, REGN5715, or a combination of both to reduce eye allergy symptoms due to birch pollen allergy

8 weeks
Visits at Day 8 and Day 57 post-CAC

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • REGN5713
  • REGN5715

Trial Overview

The study is testing two experimental drugs, REGN5713 and REGN5715, alone or in combination, against a placebo. It aims to determine their safety and effectiveness in reducing eye allergy symptoms caused by birch tree pollen.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: REGN5715Experimental Treatment1 Intervention
Group II: REGN5713-5715Experimental Treatment2 Interventions
Group III: REGN5713Experimental Treatment1 Intervention
Group IV: 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

A Study to Demonstrate the Effect of REGN5713-5715 on ...

The aim of the study is to see how safe and effective the study drug is at lowering allergic eye signs and symptoms compared with placebo. A placebo looks ...

Regeneron Advances Allergy Pipeline with Two Positive ...

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and ...

Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms ...

The aim of the study is to see how safe and effective the study drugs are at lowering eye allergy signs and symptoms compared with placebo. The study will also ...

Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms in ...

This study is researching 2 experimental drugs, REGN5713 and REGN5715. The study drugs will be either of these drugs given alone (either ...

Novel antibody cocktail targeting Bet v 1 rapidly and ...

Single-dose REGN5713/14/15 was well tolerated and provided a rapid (1 week) and durable (2 months) reduction in allergic symptoms after birch allergen nasal ...

Regeneron Advances Allergy Pipeline with ...

reduction of allergic rhinitis and conjunctivitis symptoms up to 3 months following a single subcutaneous administration of the allergen ...

Allergen-Specific Antibodies Alleviate Ocular Itch in Cat, ...

Results showed REGN5713-5715 statistically significantly reduced ocular itch by 51%, conjunctival redness by 46%, and skin prick reactivity ...

Clinical Trials Register

To assess the reduction of allergic symptoms and use of allergy-relieving medications after a single dose of REGN5713-5714-5715 versus ...