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Набор скоро начнётся NCT07675811

A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat 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: REGN-2Cat, Freneslerbart, Mevonlerbart, Placebo.
Кому может быть актуально
Состояния в реестре: Allergic Conjunctivitis. Базовые параметры: от 8 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Participants With Allergic Conjunctivitis Due to Cat Allergy

Обзор

This study is researching two experimental medicines, freneslerbart and mevonlerbart. Freneslerbart and mevonlerbart can be given alone or together. When given together, the medicine is called "REGN-2Cat". These medicines are also known as the "study drugs". The aim of the study is to see what side effects freneslerbart, mevonlerbart, and REGN-2Cat may have and if they help reduce eye allergy symptoms caused by cat hair/dander compared with a placebo. The study is looking at several other research questions, including: * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) * How long the study drug effect lasts

Вмешательства

  • Препарат REGN-2Cat
    Administered per the protocol
  • Препарат Freneslerbart
    Administered per the protocol
  • Препарат Mevonlerbart
    Administered per the protocol
  • Препарат Placebo
    Administered per the protocol

Первичные конечные точки

  • Ocular itch score in participants receiving REGN-2Cat as compared to placebo [Срок оценки: At day 8, post-Conjunctival Allergen Challenge (CAC)]
Вторичные конечные точки (12)
  • 1. Ocular itch score in participants receiving REGN-2Cat as compared to placebo [Срок оценки: Up to day 85, post-CAC]
  • 2. Conjunctival redness score in participants receiving REGN-2Cat as compared to placebo [Срок оценки: Up to day 85, post-CAC]
  • 3. Achievement of at least a 1-point reduction from baseline in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN-2Cat as compared to placebo [Срок оценки: Up to day 85, post-CAC]
  • 4. Achievement of at least a 1-point reduction from baseline in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN-2Cat as compared to placebo [Срок оценки: Up to day 85, post-CAC]
  • 5. Percent change from baseline in cat titrated Skin Prick Test (tSPT) in participants receiving REGN-2Cat as compared to placebo [Срок оценки: Up to day 85]
  • 6. Ocular itch score in participants receiving freneslerbart as compared to placebo [Срок оценки: Up to day 85, post-CAC]
  • 7. Conjunctival redness score in participants receiving freneslerbart as compared to placebo [Срок оценки: Up to day 85, post-CAC]
  • 8. Achievement of at least a 1-point reduction from baseline in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving freneslerbart as compared to placebo [Срок оценки: Up to day 85, post-CAC]
  • 9. Achievement of at least a 1-point reduction from baseline in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving freneslerbart as compared to placebo [Срок оценки: Up to day 85, post-CAC]
  • 10. Percent change from baseline in cat tSPT in participants receiving freneslerbart as compared to placebo [Срок оценки: Up to day 85]
  • 11. Ocular itch score in participants receiving mevonlerbart as compared to placebo [Срок оценки: At day 8, post-CAC]
  • 12. Conjunctival redness score in participants receiving mevonlerbart as compared to placebo [Срок оценки: At day 8, post-CAC]

Критерии участия

Критерии включения

  • Part A: adult participants aged 18 years and older. For part B: pediatric participants ≥8 years and <18 years, and adult participants aged 18 years and older.
  • Positive SPT to cat allergen extract
  • Positive specific Immunoglobulin E (sIgE) tests for cat and Fel d 1
  • Positive CAC criteria

Критерии исключения

  • Significant and/or severe environmental allergies causing symptoms (eg, ocular itching, ocular redness, etc) outside of the challenge setting that are expected to coincide or may interfere with study assessments
  • Presence of any ophthalmic disease/ abnormality/ condition that may interfere with study assessments, affect the study outcomes or participant safety
  • A clinical history of asthma with treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment as defined in the protocol

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07675811 · R1908-1909-ALG-2582

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗