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Recruiting NCT07309432

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

Phase III Interventional Allergic Conjunctivitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: REGN5713, REGN5715, Placebo.
Who it may be relevant to
Registry conditions: Allergic Conjunctivitis. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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)

Interventions

  • Drug REGN5713
    Administered per protocol
  • Drug REGN5715
    Administered per protocol
  • Drug Placebo
    Administered per protocol

Primary outcome measures

  • Ocular itch score in participants receiving REGN5713-5715 compared to placebo [Time frame: At Day 8 post-Conjunctival Allergen Challenge (CAC)]
Secondary outcome measures (12)
  • 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 [Time frame: Baseline to Day 8 post-CAC]
  • Ocular itch score in participants receiving REGN5713-5715 compared to placebo [Time frame: At Day 57 post-CAC]
  • Conjunctival redness score in participants receiving REGN5713-5715 compared to placebo [Time frame: 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 [Time frame: Baseline to Day 8 post-CAC]
  • Total Nasal Symptom Score (TNSS) in participants receiving REGN5713-5715 compared to placebo [Time frame: At Day 8 post-CAC]
  • Ocular itch score in participants receiving REGN5715 compared to placebo [Time frame: At Day 8 and 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 [Time frame: Baseline to Day 8 post-CAC]
  • Conjunctival redness score in participants receiving REGN5715 compared to placebo [Time frame: 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 [Time frame: Baseline to Day 8 post-CAC]
  • Ocular itch score in participants receiving REGN5713 compared to placebo [Time frame: At Day 8 and 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 [Time frame: Baseline to Day 8 post-CAC]
  • Conjunctival redness score in participants receiving REGN5713 compared to placebo [Time frame: At Day 8 post-CAC]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Andover Eye Associates — Andover
  • Somnos Clinical Research — Lincoln

Identifiers

NCT: NCT07309432 · R5713-5715-ALG-2556

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗