Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)
Recruiting · NCT06961214 · Interventional (participants receive a specific treatment) · Lead sponsor: GlaxoSmithKline
View the official record on ClinicalTrials.gov →Interventions studied
DepemokimabPlacebo
What this trial is about
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 take part
Age range
40 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
60 locations listed across 19 US states.
- GSK Investigational Site - Sheffield, Alabama, United States
- GSK Investigational Site - Aurora, Colorado, United States
- GSK Investigational Site - Brooksville, Florida, United States
- GSK Investigational Site - Doral, Florida, United States
- GSK Investigational Site - Fort Lauderdale, 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, 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
- GSK Investigational Site - Naples, Florida, United States
- GSK Investigational Site - New Port Richey, Florida, United States
- GSK Investigational Site - Ocala, Florida, United States
- GSK Investigational Site - Orlando, Florida, United States
- GSK Investigational Site - Ormond Beach, Florida, United States
- GSK Investigational Site - Palmetto Bay, Florida, United States
- GSK Investigational Site - St. Petersburg, Florida, United States
- GSK Investigational Site - Adairsville, Georgia, United States
- GSK Investigational Site - Cordele, Georgia, United States
- GSK Investigational Site - East Point, Georgia, United States
- GSK Investigational Site - Morrow, Georgia, United States
- GSK Investigational Site - Boise, Idaho, United States
- GSK Investigational Site - Chicago, Illinois, United States
- GSK Investigational Site - Baton Rouge, Louisiana, United States
- GSK Investigational Site - Lafayette, Louisiana, United States
- GSK Investigational Site - Shreveport, Louisiana, United States
- GSK Investigational Site - Bangor, Maine, United States
- GSK Investigational Site - Rockville, Maryland, United States
- GSK Investigational Site - Allen Park, Michigan, United States
- GSK Investigational Site - Detroit, Michigan, United States
- GSK Investigational Site - Garden City, Michigan, United States
- GSK Investigational Site - Troy, Michigan, United States
- GSK Investigational Site - Las Vegas, Nevada, United States
- GSK Investigational Site - Moorestown, New Jersey, United States
- GSK Investigational Site - Sewell, New Jersey, United States
- GSK Investigational Site - Mount Kisco, New York, United States
- GSK Investigational Site - New Windsor, New York, United States
- GSK Investigational Site - Shelby, North Carolina, United States
- GSK Investigational Site - DuBois, Pennsylvania, United States
- GSK Investigational Site - Philadelphia, Pennsylvania, United States
- GSK Investigational Site - Spartanburg, South Carolina, United States
- GSK Investigational Site - Union, South Carolina, United States
- GSK Investigational Site - Knoxville, Tennessee, United States
- GSK Investigational Site - Austin, Texas, United States
- GSK Investigational Site - Dallas, Texas, United States
- GSK Investigational Site - El Paso, Texas, United States
- GSK Investigational Site - Houston, Texas, United States
- GSK Investigational Site - Lampasas, Texas, United States
- GSK Investigational Site - Richmond, Texas, United States
- GSK Investigational Site - San Antonio, Texas, United States
- GSK Investigational Site - Webster, Texas, United States
- GSK Investigational Site - Morgantown, West Virginia, United States
- GSK Investigational Site - Alexandroupoli, Greece
- GSK Investigational Site - Ashkelon, Israel
- GSK Investigational Site - Athens, Greece
- GSK Investigational Site - Auckland, New Zealand
- GSK Investigational Site - Auckland, New Zealand
Showing 60 of 159 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →