Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescents and Adults With Birch Pollen Allergy

Part of paid clinical trials in Andover, Massachusetts.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT07309432
Phase
PHASE3
Status
Recruiting
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Conditions

  • Allergic Conjunctivitis

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REGN5713 — DRUG
    Administered per protocol
  • REGN5715 — DRUG
    Administered per protocol
  • Placebo — DRUG
    Administered per protocol

Study Details

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)

Key Dates

Start date
Jan 10, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Jun 15, 2027

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: REGN5713-5715
  • Experimental: REGN5713
  • Experimental: REGN5715
  • Placebo Comparator: Placebo

Primary Outcome Measure

Ocular itch score in participants receiving REGN5713-5715 compared to placebo [ Time Frame: At Day 8 post-Conjunctival Allergen Challenge (CAC) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Andover Eye AssociatesAndoverMassachusetts01810-

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Andover Eye Associates· Andover, MA

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