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

Recruiting · NCT07177339 · Interventional (participants receive a specific treatment) · Lead sponsor: GlaxoSmithKline

View the official record on ClinicalTrials.gov →

Interventions studied

What this trial 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 take part

Age range

40 Years to 75 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

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)

Exclusion criteria

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 it is running

60 locations listed across 16 US states.

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
GSK Investigational Site - Orlando, Florida, United States
GSK Investigational Site - Cordele, Georgia, United States
GSK Investigational Site - Dunwoody, Georgia, United States
GSK Investigational Site - Boise, Idaho, United States
GSK Investigational Site - Bowling Green, Kentucky, United States
GSK Investigational Site - Lake Charles, Louisiana, United States
GSK Investigational Site - Shreveport, Louisiana, United States
GSK Investigational Site - Bangor, Maine, United States
GSK Investigational Site - Allen Park, Michigan, United States
GSK Investigational Site - Clarkston, Michigan, United States
GSK Investigational Site - Dearborn, Michigan, United States
GSK Investigational Site - Henderson, Nevada, United States
GSK Investigational Site - Las Vegas, Nevada, United States
GSK Investigational Site - Reno, Nevada, United States
GSK Investigational Site - Winston-Salem, North Carolina, United States
GSK Investigational Site - Edmond, Oklahoma, United States
GSK Investigational Site - DuBois, Pennsylvania, United States
GSK Investigational Site - West Chester, Pennsylvania, United States
GSK Investigational Site - Greenville, South Carolina, United States
GSK Investigational Site - Rock Hill, South Carolina, United States
GSK Investigational Site - Knoxville, Tennessee, United States
GSK Investigational Site - Dallas, Texas, United States
GSK Investigational Site - DeSoto, Texas, United States
GSK Investigational Site - Greenville, Texas, United States
GSK Investigational Site - Houston, Texas, United States
GSK Investigational Site - Houston, Texas, United States
GSK Investigational Site - Houston, Texas, United States
GSK Investigational Site - Katy, Texas, United States
GSK Investigational Site - Mesquite, Texas, United States
GSK Investigational Site - Stafford, Texas, United States
GSK Investigational Site - Barcelona, Spain
GSK Investigational Site - Bedford, United Kingdom
GSK Investigational Site - Beijing, China
GSK Investigational Site - Beijing, China
GSK Investigational Site - Berlin, Germany
GSK Investigational Site - Berlin, Germany
GSK Investigational Site - Bialystok, Poland
GSK Investigational Site - Bradford, United Kingdom
GSK Investigational Site - Changchun, China
GSK Investigational Site - Changchun, China
GSK Investigational Site - Changsha, China
GSK Investigational Site - Chengdu, China
GSK Investigational Site - Chongqing, China
GSK Investigational Site - Corby, United Kingdom
GSK Investigational Site - Dongguan, China
GSK Investigational Site - Frankfurt, Germany
GSK Investigational Site - Frankfurt, Germany
GSK Investigational Site - Fujian, China

Showing 60 of 121 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →