NCT07309432 Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescents and Adults With Birch Pollen Allergy
| NCT ID | NCT07309432 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Regeneron Pharmaceuticals |
| Condition | Allergic Conjunctivitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2026-01-10 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 350 participants in total. It began in 2026-01-10 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
Eligibility Criteria
Key Inclusion Criteria: 1. Positive SPT to birch allergen extract 2. Positive allergen specific Immunoglobulin E (sIgE) tests for birch and Bet v 1 3. Positive CAC criteria Key Exclusion Criteria: 1. Significant and/or severe environmental allergies causing symptoms (outside of the challenge setting) that are expected to interfere with study assessments 2. Presence of any ophthalmic disease/abnormality/condition that may interfere with study assessments, affect the study outcomes or negatively impact participant safety 3. 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 Note: Other protocol defined Inclusion/Exclusion criteria apply.
Contact & Investigator
Clinical Trial Management
STUDY DIRECTOR
Regeneron Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07309432 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Allergic Conjunctivitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07309432 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 350 participants.
Is NCT07309432 currently recruiting?
Yes, NCT07309432 is actively recruiting participants. Contact the research team at clinicaltrials@regeneron.com for enrollment information.
Where is the NCT07309432 trial being conducted?
This trial is being conducted at Andover, United States, Lincoln, United States.
Who is sponsoring the NCT07309432 clinical trial?
NCT07309432 is sponsored by Regeneron Pharmaceuticals. The principal investigator is Clinical Trial Management at Regeneron Pharmaceuticals. The trial plans to enroll 350 participants.