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Набира участници Фаза 3 NCT06961214

Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Pulmonary Disease, Chronic Obstructive

Спонсор: GlaxoSmithKline

Налично на: БГ
Обобщение
Depemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy and safety of depemokimab compared as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.
Кой може да участва
Inclusion Criteria: * Participants must be greater than or equal to (\>=) 40 to less than or equal to (\<=) 80 years of age, at the time of signing the Informed consent * Elevated Blood Eosinophil Count (BEC) * Moderate to severe COPD with frequent exacerbations, defined as: * A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year * A post-bronchodilator forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio of \< 0.70 and a post-bronchodilator FEV1 \>30 percent (%) and \<= 80% predicted normal values * A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening * COPD assessment test (CAT) score \>=10 at Visit 1 * Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years. * Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1 * Body mass index (BMI) \>=16 kilogram per square meter (kg/m\^2) * Male and eligible female participants Exclusion Criteria: The following subjects are excluded: * Participants with a current or prior physician diagnosis of asthma * Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease * Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening 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 Screening Visit 1 * Continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day * Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension * Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure \[BiPAP\] or Continuous Positive Airway Pressure \[CPAP\]) * Unstable cardiovascular disease or arrhythmia * Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1)
Места на провеждане 14
Argentina (1)
GSK Investigational Site
Buenos Aires
US GSK Clinical Trials Call Center
Австралия (1)
GSK Investigational Site
Coffs Harbour , New South Wales
US GSK Clinical Trials Call Center
България (1)
GSK Investigational Site
Dupnitsa
US GSK Clinical Trials Call Center
Чехия (1)
GSK Investigational Site
Jindřichův Hradec
US GSK Clinical Trials Call Center
Германия (1)
GSK Investigational Site
Munich , Bavaria
US GSK Clinical Trials Call Center
Гърция (1)
GSK Investigational Site
Exochi , Thessaloniki
US GSK Clinical Trials Call Center
Израел (1)
GSK Investigational Site
Ashkelon
US GSK Clinical Trials Call Center
Италия (1)
GSK Investigational Site
Catania
US GSK Clinical Trials Call Center
Latvia (1)
GSK Investigational Site
Daugavpils
US GSK Clinical Trials Call Center
New Zealand (1)
GSK Investigational Site
Takapuna , Auckland
US GSK Clinical Trials Call Center
Румъния (1)
GSK Investigational Site
Oradea , Bihor County
US GSK Clinical Trials Call Center
Южна Корея (1)
GSK Investigational Site
Seoul
US GSK Clinical Trials Call Center
Великобритания (1)
GSK Investigational Site
Corby
US GSK Clinical Trials Call Center
САЩ (1)
GSK Investigational Site
Sheffield , Alabama
US GSK Clinical Trials Call Center
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
40 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
23.06.2025
Крайна дата
21.08.2029
Регистрационен номер
NCT06961214
Източник
anzctr
Запитване за медицински туризъм

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