Last updated 8 months ago
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
981 patients around the world
Available in United States, Argentina
GlaxoSmithKline
1Research sites
981Patients around the world
This study is for people with
Chronic obstructive pulmonary disease
Copd
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- 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.
- 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).
Sites
Clínica 25 de Mayo - Mar del Plata
Recruiting
StudyENDURA -1
SponsorGlaxoSmithKline
Study typeInterventional
Conditions
Copd
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06959095
