Depemokimab: Depemokimab as a sterile liquid formulation will be administered.
Placebo: Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered
Study summary
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.
Eligibility
Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
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)
Primary outcome measure(s)
Annualized Rate of Moderate/Severe Exacerbations — From Baseline up to Week 104 Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (i.e., greater than or equal to \[\>=\] 24 hours) or result in death. The frequency of moderate/ severe exacerbations expressed as an annualized exacerbation rate will be evaluated.
Trial sites (159)
Facility
City
Region
Status
GSK Investigational Site
Sheffield
Alabama
Recruiting
GSK Investigational Site
Aurora
Colorado
Recruiting
GSK Investigational Site
Brooksville
Florida
Recruiting
GSK Investigational Site
Doral
Florida
Recruiting
GSK Investigational Site
Fort Lauderdale
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami Lakes
Florida
Recruiting
GSK Investigational Site
Naples
Florida
Recruiting
GSK Investigational Site
New Port Richey
Florida
Recruiting
GSK Investigational Site
Ocala
Florida
Recruiting
GSK Investigational Site
Orlando
Florida
Recruiting
GSK Investigational Site
Ormond Beach
Florida
Recruiting
GSK Investigational Site
Palmetto Bay
Florida
Recruiting
GSK Investigational Site
St. Petersburg
Florida
Recruiting
GSK Investigational Site
Adairsville
Georgia
Recruiting
GSK Investigational Site
Cordele
Georgia
Recruiting
GSK Investigational Site
East Point
Georgia
Recruiting
GSK Investigational Site
Morrow
Georgia
Recruiting
GSK Investigational Site
Boise
Idaho
Recruiting
GSK Investigational Site
Chicago
Illinois
Recruiting
GSK Investigational Site
Baton Rouge
Louisiana
Recruiting
GSK Investigational Site
Lafayette
Louisiana
Recruiting
GSK Investigational Site
Shreveport
Louisiana
Recruiting
GSK Investigational Site
Bangor
Maine
Recruiting
GSK Investigational Site
Rockville
Maryland
Recruiting
GSK Investigational Site
Allen Park
Michigan
Recruiting
GSK Investigational Site
Detroit
Michigan
Recruiting
GSK Investigational Site
Garden City
Michigan
Recruiting
GSK Investigational Site
Troy
Michigan
Recruiting
GSK Investigational Site
Las Vegas
Nevada
Recruiting
GSK Investigational Site
Moorestown
New Jersey
Recruiting
GSK Investigational Site
Sewell
New Jersey
Recruiting
GSK Investigational Site
Mount Kisco
New York
Recruiting
GSK Investigational Site
New Windsor
New York
Recruiting
+ 119 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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