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

A vizsgálat adatai

Ki végzi

GlaxoSmithKline

Azonosító

NCT06959095EU 2024-520418-22-00

A regiszteradat frissítve

2026. október 5.

Eredeti leírás

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 as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.A teljes eredeti leírásKevesebb

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

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 as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.

Bevonási feltételek: 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 less than (<) 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 or eligible female participants.

Kizáró feltételek: Participants with a current or prior physician diagnosis of asthma; Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1; Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1; Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease; Lung resection: Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure; Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension; Unstable cardiovascular disease or arrhythmia; Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1); The following subjects are excluded:; Continuous oxygen: Participants requiring oxygen supplementation for more than 16 hours per day to maintain resting oxygen saturation greater than 88%; Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure [BiPAP] or Continuous Positive Airway Pressure [CPAP]).

ClinicalTrials.gov NCT06959095 · EU CTIS 2024-520418-22-00