NCT07309432
Recruiting
Phase 3
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
Regeneron Pharmaceuticals1 site in 1 country350 target enrollmentStarted: January 10, 2026Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Ocular itch score in participants receiving REGN5713-5715 compared to placebo
Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Note: Other protocol defined Inclusion/Exclusion criteria apply.
Arms & Interventions
REGN5713-5715
Experimental
Intervention: REGN5713 (Drug)
REGN5713-5715
Experimental
Intervention: REGN5715 (Drug)
REGN5713
Experimental
Intervention: REGN5713 (Drug)
REGN5715
Experimental
Intervention: REGN5715 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Ocular itch score in participants receiving REGN5713-5715 compared to placebo
Time Frame: At Day 8 post-Conjunctival Allergen Challenge (CAC)
Assessed using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale, a 0-4 scale where 0 = none and 4= incapacitating itch, 0.5 unit increments
Secondary Outcomes
- Ocular itch score in participants receiving REGN5713-5715 compared to placebo(At Day 57 post-CAC)
- Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo(Baseline to Day 57 post-CAC)
- Occurrence of Anti-Drug Antibodies (ADA) responses to REGN5713(Up to Day 113)
- Occurrence of ADA responses to REGN5715(Up to Day 113)
- Magnitude of ADA to REGN5715(Up to Day 113)
- Conjunctival redness score in participants receiving REGN5713-5715 compared to placebo(At Day 8 and Day 57 post-CAC)
- Achievement of at least a 1-point reduction in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo(Baseline to Day 57 post-CAC)
- Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5715 compared to placebo(Baseline to Day 8 post-CAC)
- Conjunctival redness score in participants receiving REGN5713 compared to placebo(At Day 8 post-CAC)
- Achievement of at least a 1-point reduction in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713 compared to placebo(Baseline to Day 8 post-CAC)
- Total Nasal Symptom Score (TNSS) in participants receiving REGN5713-5715 compared to placebo(At Day 8 post-CAC)
- Ocular itch score in participants receiving REGN5715 compared to placebo(At Day 8 and Day 57 post-CAC)
- Conjunctival redness score in participants receiving REGN5715 compared to placebo(At Day 8 post-CAC)
- Achievement of at least a 1-point reduction in conjunctival redness score in for at least 2 out of 3 post-CAC time points participants receiving REGN5715 compared to placebo(Baseline to Day 8 post-CAC)
- Ocular itch score in participants receiving REGN5713 compared to placebo(At Day 8 and Day 57 post-CAC)
- Ocular itch score in participants receiving REGN5713-5715 compared to REGN5715(Baseline to Day 8 post-CAC)
- Percent change in birch tSPT in participants receiving REGN5713 compared to placebo(Baseline, at Day 8 and at Day 57 post-CAC)
- Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713 compared to placebo(Baseline to Day 8 post-CAC)
- Ocular itch score in participants receiving REGN5713-5715 compared to REGN5713(Baseline to Day 8 post-CAC)
- Percent change in birch titrated Skin Prick Test (tSPT) in participants receiving REGN5713-5715 compared to placebo(Baseline and at Day 8 post-CAC)
- Achievements of different response thresholds for the ocular itch score among participants receiving REGN5713-5715, REGN5713, REGN5715 or placebo(Baseline to Day 8 post-CAC)
- Ciliary redness score in participants receiving REGN5713-5715 compared to placebo(At Day 8 and Day 57 post-CAC)
- Episcleral redness score in participants receiving REGN5713-5715 compared to placebo(At Day 8 and Day 57 post-CAC)
- Total redness score in participants receiving REGN5713-5715 compared to placebo(At Day 8 and Day 57 post-CAC)
- Percent change in birch tSPT in participants receiving REGN5713-5715 compared to placebo(Baseline and at Day 57 post-CAC)
- Percent change in birch tSPT in participants receiving REGN5715 compared to placebo(Baseline, at Day 8 and at Day 57 post-CAC)
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)(Up to Day 113)
- Occurrence of Treatment Emergent-Serious Adverse Events (TE-SAEs)(Up to Day 113)
- Concentrations of total REGN5713 is serum over time(Up to Day 113)
- Concentrations of total REGN5715 is serum over time(Up to Day 113)
- Severity of TEAEs(Up to Day 113)
- Magnitude of ADA to REGN5713(Up to Day 113)
- Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo(Baseline to Day 8 post-CAC)
- Achievement of at least a 1-point reduction in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo(Baseline to Day 8 post-CAC)
Investigators
Study Sites (1)
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