Идёт набор NCT07177339

eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation

Фаза III С лечением Pulmonary Disease, Chronic Obstructive

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: Depemokimab, Placebo.
Кому может быть актуально: Состояния в реестре: Pulmonary Disease, Chronic Obstructive. Базовые параметры: 40 лет — 75 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, Австралия, Болгария, Канада, Китай +8
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 Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study of the Efficacy and Safety of Early Depemokimab Initiation as add-on Treatment in COPD Patients With Type 2 Inflammation

Обзор

Depemokimab is being developed as a treatment for individuals with moderate to severe Chronic Obstructive Pulmonary Disorder (COPD). The aim of this study is to assess the efficacy and safety of early initiation of depemokimab as an add-on medicine in participants with moderate to severe COPD with type 2 inflammation.

Вмешательства

Препарат Depemokimab
Depemokimab will be administered.
Препарат Placebo
Matching placebo will be administered.

Первичные конечные точки

Annualized Rate of Moderate/Severe Exacerbations [Срок оценки: From Baseline Up to Week 156]

Вторичные конечные точки (3)

Time to First Moderate/Severe Exacerbation [Срок оценки: From Baseline Up to Week 156]
Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 [Срок оценки: From Baseline up to Week 52]
Change from Baseline in Evaluating Respiratory Symptoms (E-RS): COPD Total Score at Week 52 [Срок оценки: From Baseline up to Week 52]

Критерии участия

Критерии включения

Male or eligible female participants
Eosinophilic phenotype measured using Blood Eosinophil Count (BEC)
Moderate to severe COPD, defined as

A clinically documented history of COPD for at least 1 year
A post-salbutamol Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio of less than (<)0.70 and a post-salbutamol FEV1 greater than (>)30 percent (%) and <80% predicted normal values
Elevated risk for exacerbations, defined as

A well-documented history of only 1 moderate COPD exacerbation in the prior 12 months and
The presence of risk factors for future exacerbations/deterioration such as:
Modified Medical Research Council (mMRC) dyspnea score >= 2
COPD Assessment Test (CAT) >= 15
Post-bronchodilator FEV1 < 50% predicted
Chronic bronchitis
Smoking status: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Screening.
Dual (Inhaled corticosteroid (ICS)+ Long-acting beta2-adrenergic receptor agonist \[LABA\] or LABA+ Long-acting muscarinic receptor antagonist \[LAMA\]) or triple (ICS+LABA+LAMA) inhaler therapy as assessed by the investigator for at least 3 months
Body mass index (BMI) >=16 kilograms per square meter (kg/m\^2)

Критерии исключения

The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of lung disease, and clinical manifestations of lung disease where primary diagnosis is not COPD are excluded

Participants with a current or prior physician diagnosis of asthma
Participants with childhood asthma are permitted, provided that childhood asthma has resolved before 18 years of age and has not recurred
Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease.
COPD severity: Participants with more than one moderate exacerbation or severe exacerbation in the past 12 months prior to Visit 1
COPD stability: Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Visit 1
Lung resection: Participants with a history of, or plan for lung volume reduction surgery/endobronchial valve procedure
Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1
Chronic hypercapnia requiring non-invasive positive pressure ventilation (NIPPV) use including Bi-Level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) are excluded
Continuous oxygen: Participants requiring oxygen supplementation for COPD

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

Китай · 45 центров

GSK Investigational Site — Shapingba
GSK Investigational Site — Nanning
GSK Investigational Site — Чэнду
GSK Investigational Site — Чэнду
GSK Investigational Site — Suining
GSK Investigational Site — Пекин
GSK Investigational Site — Пекин
GSK Investigational Site — Changchun
… и ещё 37 центров

США · 42 центра

GSK Investigational Site — Newport Beach
GSK Investigational Site — Lakewood
GSK Investigational Site — Brandon
GSK Investigational Site — Crystal River
GSK Investigational Site — Doral
GSK Investigational Site — Greenacres City
GSK Investigational Site — Hialeah
GSK Investigational Site — Hollywood
… и ещё 34 центра

Болгария · 6 центров

GSK Investigational Site — Haskovo
GSK Investigational Site — Montana
GSK Investigational Site — Rousse
GSK Investigational Site — Sofia
GSK Investigational Site — Sofia
GSK Investigational Site — Sofia

Германия · 6 центров