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Идёт набор NCT07309432

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

Фаза III С лечением Allergic Conjunctivitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: REGN5713, REGN5715, Placebo.
Кому может быть актуально
Состояния в реестре: Allergic Conjunctivitis. Базовые параметры: от 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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)

Вмешательства

  • Препарат REGN5713
    Administered per protocol
  • Препарат REGN5715
    Administered per protocol
  • Препарат Placebo
    Administered per protocol

Первичные конечные точки

  • Ocular itch score in participants receiving REGN5713-5715 compared to placebo [Срок оценки: At Day 8 post-Conjunctival Allergen Challenge (CAC)]
Вторичные конечные точки (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 [Срок оценки: Baseline to Day 8 post-CAC]
  • Ocular itch score in participants receiving REGN5713-5715 compared to placebo [Срок оценки: At Day 57 post-CAC]
  • Conjunctival redness score in participants receiving REGN5713-5715 compared to placebo [Срок оценки: 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 [Срок оценки: Baseline to Day 8 post-CAC]
  • Total Nasal Symptom Score (TNSS) in participants receiving REGN5713-5715 compared to placebo [Срок оценки: At Day 8 post-CAC]
  • Ocular itch score in participants receiving REGN5715 compared to placebo [Срок оценки: 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 [Срок оценки: Baseline to Day 8 post-CAC]
  • Conjunctival redness score in participants receiving REGN5715 compared to placebo [Срок оценки: 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 [Срок оценки: Baseline to Day 8 post-CAC]
  • Ocular itch score in participants receiving REGN5713 compared to placebo [Срок оценки: 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 [Срок оценки: Baseline to Day 8 post-CAC]
  • Conjunctival redness score in participants receiving REGN5713 compared to placebo [Срок оценки: At Day 8 post-CAC]

Критерии участия

Критерии включения

  • Positive SPT to birch allergen extract
  • Positive allergen specific Immunoglobulin E (sIgE) tests for birch and Bet v 1
  • Positive CAC criteria

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Andover Eye Associates — Andover
  • Somnos Clinical Research — Lincoln

Идентификаторы

NCT: NCT07309432 · R5713-5715-ALG-2556

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗