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 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 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
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 16 hours per day to maintain resting oxygen saturation greater than 88%
* 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 (281)
Facility
City
Region
Status
GSK Investigational Site
Bakersfield
California
Recruiting
GSK Investigational Site
Modesto
California
Recruiting
GSK Investigational Site
Newport Beach
California
Recruiting
GSK Investigational Site
Wilmington
Delaware
Recruiting
GSK Investigational Site
Bradenton
Florida
Recruiting
GSK Investigational Site
Brandon
Florida
Recruiting
GSK Investigational Site
Hialeah
Florida
Recruiting
GSK Investigational Site
Hialeah
Florida
Recruiting
GSK Investigational Site
Loxahatchee Groves
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami Lakes
Florida
Recruiting
GSK Investigational Site
Orange City
Florida
Recruiting
GSK Investigational Site
Palm Springs
Florida
Recruiting
GSK Investigational Site
Palmetto Bay
Florida
Recruiting
GSK Investigational Site
Pensacola
Florida
Recruiting
GSK Investigational Site
Tamarac
Florida
Recruiting
GSK Investigational Site
Tampa
Florida
Recruiting
GSK Investigational Site
The Villages
Florida
Recruiting
GSK Investigational Site
Riverdale
Georgia
Recruiting
GSK Investigational Site
Stonecrest
Georgia
Recruiting
GSK Investigational Site
Chicago
Illinois
Recruiting
GSK Investigational Site
Baltimore
Maryland
Recruiting
GSK Investigational Site
Clarkston
Michigan
Recruiting
GSK Investigational Site
Flint
Michigan
Recruiting
GSK Investigational Site
St Louis
Missouri
Recruiting
GSK Investigational Site
Henderson
Nevada
Recruiting
GSK Investigational Site
Las Vegas
Nevada
Recruiting
GSK Investigational Site
Reno
Nevada
Recruiting
GSK Investigational Site
North Massapequa
New York
Recruiting
GSK Investigational Site
Winston-Salem
North Carolina
Recruiting
GSK Investigational Site
Winston-Salem
North Carolina
Recruiting
GSK Investigational Site
Greenville
South Carolina
Recruiting
GSK Investigational Site
Rock Hill
South Carolina
Recruiting
GSK Investigational Site
Franklin
Tennessee
Recruiting
GSK Investigational Site
Corsicana
Texas
Recruiting
GSK Investigational Site
Dallas
Texas
Recruiting
GSK Investigational Site
Houston
Texas
Recruiting
GSK Investigational Site
Houston
Texas
Recruiting
GSK Investigational Site
Houston
Texas
Recruiting
+ 241 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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