RECRUITINGPhase 3INTERVENTIONAL
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
A Randomized, Double-Blind, Placebo- Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Depemokimab In Adult Participants With COPD With Type 2 Inflammation
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form.
- 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.
Who Should NOT Join This Trial:
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.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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 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).
Treatments Being Tested
DRUG
Depemokimab
Depemokimab as a sterile liquid formulation will be administered.
DRUG
Placebo
Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered.
Locations (15)
GSK Investigational Site
Loxahatchee Groves, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Rock Hill, South Carolina, United States
GSK Investigational Site
Corsicana, Texas, United States
GSK Investigational Site
Changsha, Hunan, China
GSK Investigational Site
Chengdu, Sichuan, China
GSK Investigational Site
Chengdu, China
GSK Investigational Site
Guangzhou, China
GSK Investigational Site
Hangzhou, China
GSK Investigational Site
Jiangmen, China
GSK Investigational Site
Jiangxi, China
GSK Investigational Site
Mianyang, China
GSK Investigational Site
Qingyuan, China
GSK Investigational Site
Zigong, China
GSK Investigational Site
Tokyo, Japan