Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescents and Adults With Birch Po… (NCT07309432) | Clinical Trial Compass
RecruitingPhase 3
Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescents and Adults With Birch Pollen Allergy
United States350 participantsStarted 2026-01-10
Plain-language summary
This study is researching 2 experimental drugs, REGN5713 and REGN5715. The study drugs will be either of these drugs given alone (either REGN5713 or REGN5715) or given together (REGN5713 and REGN5715) to reduce eye allergy signs and symptoms due to birch tree pollen allergy.
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 evaluate whether the combination (REGN5713-5715) has different effectiveness than REGN5713 or REGN5715 alone.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drugs
* How much of the study drugs is in the blood at different times
* Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Positive SPT to birch allergen extract
. Positive allergen specific Immunoglobulin E (sIgE) tests for birch and Bet v 1
. Positive CAC criteria
Exclusion criteria
. Significant and/or severe environmental allergies causing symptoms (outside of the challenge setting) that are expected to interfere with study assessments
. Presence of any ophthalmic disease/abnormality/condition that may interfere with study assessments, affect the study outcomes or negatively impact participant safety
. A clinical history of asthma with treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment more than twice within prior 12 months or once within 3 months prior to screening visit 1 or has been hospitalized or has attended the Emergency Room/Urgent Care facility for asthma in the 12 months prior to screening
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ocular itch score in participants receiving REGN5713-5715 compared to placebo
Timeframe: At Day 8 post-Conjunctival Allergen Challenge (CAC)