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Bakerly",{"type":2513,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100589961","phase-3-depemokimab-as-an-extended-treatment-duration-biologic-in-adults-with-chronic-obstructive-pulmonary-disease-copd-and-type-2-inflammation-endura-2-100589961",false,"NCT06961214","Depemokimab as an Extended Treatment Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)","A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Depemokimab in Adult Participants With COPD With Type 2 Inflammation","ENDURA-2","Inclusion Criteria:\n\n* Participants must be greater than or equal to (\\>=) 40 to less than or equal to (\\\u003C=) 80 years of age, at the time of signing the Informed consent\n* Elevated Blood Eosinophil Count (BEC)\n* Moderate to severe COPD with frequent exacerbations, defined as:\n\n  * A clinically documented history of COPD as defined by the American Thoracic Society\u002FEuropean Respiratory Society for at least 1 year\n  * A post-bronchodilator forced expiratory volume in one second (FEV1)\u002F forced vital capacity (FVC) ratio of \\\u003C 0.70 and a post-bronchodilator FEV1 \\>30 percent (%) and \\\u003C= 80% predicted normal values\n  * A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening\n* COPD assessment test (CAT) score \\>=10 at Visit 1\n* Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \\>=10 pack-years.\n* 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\n* Body mass index (BMI) \\>=16 kilogram per square meter (kg\u002Fm\\^2)\n* Male and eligible female participants\n\nExclusion Criteria:\n\nThe following subjects are excluded:\n\n* Participants with a current or prior physician diagnosis of asthma\n* Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease\n* Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1\n* Lung resection: Participants with a history of or plan for lung volume reduction surgery \u002F endobronchial valve procedure.\n* Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1\n* Continuous oxygen: Participants requiring oxygen supplementation for more than 16 hours per day to maintain resting oxygen saturation greater than 88%\n* Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension\n* Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure \\[BiPAP\\] or Continuous Positive Airway Pressure \\[CPAP\\])\n* Unstable cardiovascular disease or arrhythmia\n* Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1)","ALL","40 Years","80 Years",{"count":2526,"type":2527},961,"ESTIMATED","INTERVENTIONAL",[2530],"PHASE3","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.",[2533],"Pulmonary Disease, Chronic Obstructive",[46,63,2535,2536,2537,2538,2539,2540,2541,52,2542],"Eosinophilic phenotype","Chronic obstructive pulmonary disease","COPD","Moderate COPD","Severe COPD","Uncontrolled Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)","Exacerbations","Type 2 inflammation","2026-10-01",{"date":2545,"type":2546},"2026-10-05","ACTUAL",{"date":2548,"type":2546},"2025-06-23",{"date":2550,"type":2527},"2029-02-14",{"name":5,"class":6},193]