Language: BG BG
← Back to results
Recruiting Phase 3 NCT06961214

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

Phase 3 – large-scale trial before approval
Conditions: Pulmonary Disease, Chronic Obstructive

Sponsor: GlaxoSmithKline

trial.available_in: БГ
Overview
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.
Who can participate
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)
Locations 14
Argentina (1)
GSK Investigational Site
Buenos Aires
US GSK Clinical Trials Call Center
Australia (1)
GSK Investigational Site
Coffs Harbour , New South Wales
US GSK Clinical Trials Call Center
Bulgaria (1)
GSK Investigational Site
Dupnitsa
US GSK Clinical Trials Call Center
Czech Republic (1)
GSK Investigational Site
Jindřichův Hradec
US GSK Clinical Trials Call Center
Germany (1)
GSK Investigational Site
Munich , Bavaria
US GSK Clinical Trials Call Center
Greece (1)
GSK Investigational Site
Exochi , Thessaloniki
US GSK Clinical Trials Call Center
Israel (1)
GSK Investigational Site
Ashkelon
US GSK Clinical Trials Call Center
Italy (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
Romania (1)
GSK Investigational Site
Oradea , Bihor County
US GSK Clinical Trials Call Center
South Korea (1)
GSK Investigational Site
Seoul
US GSK Clinical Trials Call Center
United Kingdom (1)
GSK Investigational Site
Corby
US GSK Clinical Trials Call Center
United States (1)
GSK Investigational Site
Sheffield , Alabama
US GSK Clinical Trials Call Center
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
40 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
23.06.2025
Completion date
21.08.2029
Registry ID
NCT06961214
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.