Bet v1 antibody treatment for birch pollen eye allergy in teens and adults
A Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Bet v 1 Monoclonal Antibodies in Participants With Allergic Conjunctivitis Due to Birch Pollen Allergy
This trial will test whether two experimental Bet v1 antibody medicines, given alone or together, can reduce eye allergy signs and symptoms in teens and adults with birch pollen allergy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Andover, Massachusetts) |
| Trial ID | NCT07309432 on ClinicalTrials.gov |
What this trial studies
This Phase 3, randomized interventional trial compares two investigational antibodies (REGN5713 and REGN5715) given alone or together versus placebo to reduce ocular allergy signs and symptoms triggered by birch pollen. Participants are selected based on positive skin prick and specific IgE tests to birch/Bet v 1 and a positive conjunctival allergen challenge. The study will collect safety data, measure drug levels in the blood, and check for anti-drug antibodies, while monitoring changes in ocular signs and symptoms. Outcomes will compare each active arm with placebo and examine whether the combination provides different effects than either antibody alone.
Who should consider this trial
Good fit: Ideal candidates are adolescents and adults with confirmed birch pollen sensitization (positive skin prick, positive sIgE to birch/Bet v 1, and positive conjunctival allergen challenge) who can attend site visits and do not have interfering eye disease or uncontrolled asthma.
Not a fit: People whose eye symptoms are caused by non-birch allergens, who have ophthalmic conditions that affect assessments, or who have uncontrolled asthma or other exclusionary conditions are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the treatment could reduce eye allergy signs and symptoms from birch pollen for adolescents and adults and potentially reduce reliance on symptom medicines.
How similar studies have performed: Related approaches such as allergen immunotherapy and anti-IgE treatments have reduced allergic eye symptoms, but directly targeting Bet v 1 with monoclonal antibodies is a newer strategy with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Andover, Massachusetts
- Andover Eye Associates — Andover, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.