NCT06959095PHASE3Recruiting
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
GlaxoSmithKline
Start Date
6/20/2025
Completion Date
8/20/2029
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 Criteria
Age Range: 40 years to 80 years
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).
Interventions
DRUG
Depemokimab
DRUG
Placebo
Conditions
Pulmonary Disease, Chronic Obstructive
Locations
GSK Investigational Site
Loxahatchee Groves, Florida 33470
United States
GSK Investigational Site
Miami, Florida 33155
United States
GSK Investigational Site
Rock Hill, South Carolina 29732
United States
GSK Investigational Site
Corsicana, Texas 75110
United States
GSK Investigational Site
Changsha, Hunan 410015
China
GSK Investigational Site
Chengdu, Sichuan
China
GSK Investigational Site
Chengdu, 610041
China
GSK Investigational Site
Guangzhou, 510150
China
GSK Investigational Site
Hangzhou, 310000
China
GSK Investigational Site
Jiangmen, 529000
China
GSK Investigational Site
Jiangxi,
China
GSK Investigational Site
Mianyang,
China
GSK Investigational Site
Qingyuan, 511500
China
GSK Investigational Site
Zigong, 643036
China
GSK Investigational Site
Tokyo, 140-8522
Japan