REGN5713 + REGN5715 for Allergic Eye
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.12345Why 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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive REGN5713, REGN5715, or a combination of both to reduce eye allergy symptoms due to birch pollen allergy
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
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 ...
2.
newsroom.regeneron.com
newsroom.regeneron.com/news-releases/news-release-details/regeneron-advances-allergy-pipeline-two-positive-phase-3-trialsRegeneron 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 ...
4.
ctv.veeva.com
ctv.veeva.com/study/study-of-bet-v1-antibodies-effect-on-eye-allergy-symptoms-in-adolescents-and-adults-with-birch-polleStudy 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 ...
7.
empr.com
empr.com/news/allergen-specific-antibodies-alleviate-ocular-itch-in-cat-birch-pollen-allergy-trials/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 ...
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