eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation

What this study is about

Depemokimab is being developed as a treatment for individuals with moderate to severe Chronic Obstructive Pulmonary Disorder (COPD). The aim of this study is to assess the efficacy and safety of early initiation of depemokimab as an add-on medicine in participants with moderate to severe COPD with type 2 inflammation.

Who can join (things the study team will check)

✅ You may be able to join if…

• Male or eligible female participants
• Eosinophilic phenotype measured using Blood Eosinophil Count (BEC)
• Moderate to severe COPD, defined as
  • A clinically documented history of COPD for at least 1 year
  • A post-salbutamol Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio of less than (<)0.70 and a post-salbutamol FEV1 greater than (>)30 percent (%) and <80% predicted normal values
• Elevated risk for exacerbations, defined as
  • A well-documented history of only 1 moderate COPD exacerbation in the prior 12 months and
  • The presence of risk factors for future exacerbations/deterioration such as:
  • Modified Medical Research Council (mMRC) dyspnea score >= 2
  • COPD Assessment Test (CAT) >= 15
  • Post-bronchodilator FEV1 < 50% predicted
  • Chronic bronchitis
• Smoking status: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Screening.
• Dual (Inhaled corticosteroid (ICS)+ Long-acting beta2-adrenergic receptor agonist [LABA] or LABA+ Long-acting muscarinic receptor antagonist [LAMA]) or triple (ICS+LABA+LAMA) inhaler therapy as assessed by the investigator for at least 3 months
• Body mass index (BMI) >=16 kilograms per square meter (kg/m\^2)

🚫 You may not be able to join if…

• The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of lung disease, and clinical manifestations of lung disease where primary diagnosis is not COPD are excluded
  • Participants with a current or prior physician diagnosis of asthma
  • Participants with childhood asthma are permitted, provided that childhood asthma has resolved before 18 years of age and has not recurred
• Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease.
• COPD severity: Participants with more than one moderate exacerbation or severe exacerbation in the past 12 months prior to Visit 1
• COPD stability: Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to 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 Visit 1
• Chronic hypercapnia requiring non-invasive positive pressure ventilation (NIPPV) use including Bi-Level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) are excluded
• Continuous oxygen: Participants requiring oxygen supplementation for COPD

Where this trial is running

• GSK Investigational Site, Newport Beach, California, United States
• GSK Investigational Site, Lakewood, Colorado, United States
• GSK Investigational Site, Brandon, Florida, United States
• GSK Investigational Site, Crystal River, Florida, United States
• GSK Investigational Site, Doral, Florida, United States
• GSK Investigational Site, Greenacres City, Florida, United States
• GSK Investigational Site, Hialeah, Florida, United States
• GSK Investigational Site, Hollywood, Florida, United States
• GSK Investigational Site, Miami, Florida, United States
• GSK Investigational Site, Miami, Florida, United States
• GSK Investigational Site, Miami, Florida, United States
• GSK Investigational Site, Miami Lakes, Florida, United States

+ 109 more sites.

Who to contact

US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07177339.