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.
Eligibility
Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Annualized Rate of Moderate/Severe Exacerbations — From Baseline Up to Week 156 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 (that is greater than or equal to \[\>=\] 24 hours) or result in death. The frequency of moderate/ severe exacerbations expressed as an annualized rate of moderate or severe exacerbations will be reported.
Trial sites (121)
Facility
City
Region
Status
GSK Investigational Site
Newport Beach
California
Recruiting
GSK Investigational Site
Lakewood
Colorado
Recruiting
GSK Investigational Site
Brandon
Florida
Recruiting
GSK Investigational Site
Crystal River
Florida
Recruiting
GSK Investigational Site
Doral
Florida
Recruiting
GSK Investigational Site
Greenacres City
Florida
Recruiting
GSK Investigational Site
Hialeah
Florida
Recruiting
GSK Investigational Site
Hollywood
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
Orlando
Florida
Recruiting
GSK Investigational Site
Cordele
Georgia
Recruiting
GSK Investigational Site
Dunwoody
Georgia
Recruiting
GSK Investigational Site
Boise
Idaho
Recruiting
GSK Investigational Site
Bowling Green
Kentucky
Recruiting
GSK Investigational Site
Lake Charles
Louisiana
Recruiting
GSK Investigational Site
Shreveport
Louisiana
Recruiting
GSK Investigational Site
Bangor
Maine
Recruiting
GSK Investigational Site
Allen Park
Michigan
Recruiting
GSK Investigational Site
Clarkston
Michigan
Recruiting
GSK Investigational Site
Dearborn
Michigan
Recruiting
GSK Investigational Site
Henderson
Nevada
Recruiting
GSK Investigational Site
Las Vegas
Nevada
Recruiting
GSK Investigational Site
Reno
Nevada
Recruiting
GSK Investigational Site
Winston-Salem
North Carolina
Recruiting
GSK Investigational Site
Edmond
Oklahoma
Recruiting
GSK Investigational Site
DuBois
Pennsylvania
Recruiting
GSK Investigational Site
West Chester
Pennsylvania
Recruiting
GSK Investigational Site
Greenville
South Carolina
Recruiting
GSK Investigational Site
Rock Hill
South Carolina
Recruiting
GSK Investigational Site
Knoxville
Tennessee
Recruiting
GSK Investigational Site
Dallas
Texas
Recruiting
GSK Investigational Site
DeSoto
Texas
Recruiting
GSK Investigational Site
Greenville
Texas
Recruiting
GSK Investigational Site
Houston
Texas
Recruiting
GSK Investigational Site
Houston
Texas
Recruiting
GSK Investigational Site
Houston
Texas
Recruiting
GSK Investigational Site
Katy
Texas
Recruiting
+ 81 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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.