Идёт набор NCT06878261

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

Фаза III С лечением Chronic Obstructive Pulmonary Disease (COPD)

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: Tezepelumab, Placebo.
Кому может быть актуально: Состояния в реестре: Chronic Obstructive Pulmonary Disease (COPD). Базовые параметры: 40 лет — 80 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, Аргентина, Австралия, Бельгия, Болгария +17
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Обзор

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Подробное описание

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.

Вмешательства

Биопрепарат Tezepelumab
Tezepelumab subcutaneous injection
Другое Placebo
Placebo subcutaneous injection

Первичные конечные точки

Annualised rate of moderate or severe COPD exacerbations [Срок оценки: Baseline up to 76 weeks]

Вторичные конечные точки (12)

Change from baseline in post-BD FEV1 [Срок оценки: From baseline to Week 52]
Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) [Срок оценки: From baseline to Week 52]
Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score [Срок оценки: From baseline over 52 weeks]
Annualised rate of moderate or severe COPD exacerbations among participants with EOS ≥ 300 cells/µL collected during screening visit. [Срок оценки: Baseline up to 76 weeks]
Annualised rate of severe COPD exacerbations [Срок оценки: Baseline up to 76 weeks]
Annualised rate of COPD exacerbations requiring ER visit and/or hospitalisation [Срок оценки: Baseline up to 76 Weeks]
Clinical meaningful improvement in St. George's Respiratory Questionnaire (SGRQ) total score [Срок оценки: From baseline over 52 weeks]
Change from baseline in the COPD assessment Test (CAT) total score [Срок оценки: From baseline over 52 weeks]
Clinical meaningful improvement in COPD Assessment Test (CAT) total score [Срок оценки: From baseline over 52 weeks]
Time to first moderate or severe COPD exacerbation [Срок оценки: Baseline up to 76 weeks]
Time to first severe COPD exacerbation [Срок оценки: Baseline up to 76 weeks]
Pharmacokinetics (PK): Serum trough concentrations [Срок оценки: Baseline, Week 24, Week 36, Week 52]

Критерии участия

Критерии включения

≥40 to ≤80 years old
COPD diagnosis ≥1 year,
Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC <0.70 at screening
Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1
≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy
EOS ≥ 150 cells/μL during screening
CAT ≥15 at screening
Former or current smokers ≥10 pack-years

Критерии исключения

Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD
Asthma, incl. pediatric, or ACOS
Any unstable disorder that can impact participants safety or study outcomes
Tuberculosis requiring treatment within 12 months prior V2
Malignancies current or past

Concomitant therapies:

Macrolides (less than 6 months)
Systemic immuno-suppressive, -modulating medications
LTOT >4.0 L/min or O2 saturation <89% despite LTOT

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