Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Depemokimab, GSK3511294, Eosinophilic phenotype, Chronic obstructive pulmonary disease, (COPD), Moderate COPD, Severe COPD, Uncontrolled Moderate to Severe Chronic Obstructive Pulmonary Disease, Exacerbations, Placebo, Type 2 inflammation
Brief 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.
Interventions
DRUGDepemokimab
Depemokimab as a sterile liquid formulation will be administered.
DRUGPlacebo
Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is a double-blind study neither the participants the caregivers the researchers nor the people assessing the outcomes know which treatment is being given to whom.
Intervention model description
This is a placebo-controlled, multicenter trial
Eligibility
Sex/Gender
ALL
Age
40 Years to 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 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Moderate/Severe Exacerbation | 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. |
| Change From Baseline in St. Georges Respiratory Questionnaire (SGRQ) Total Score at Week 52 | From Baseline up to Week 52 | The SGRQ total score will be measured using the SGRQ for COPD \[SGRQ-C\]. The SGRQ-C is a 40-item participant questionnaire designed to measure health impairment by addressing the frequency of respiratory symptoms (questions 1-7) and the participant's current state (questions 8-14). The questions are designed to be self-completed by the participant. The total score will be calculated on 0-100 rating scale and scores expressed as a percentage of overall impairment. Higher scores indicate greater impairment of health. |
| Change From Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) Total Score at Week 52 | From Baseline up to Week 52 | E-RS:COPD consists of 11 items from the 14-item Exacerbations of Chronic Pulmonary Disease Tool - Patient Reported Outcomes (EXACT) instrument. E-RS: COPD is intended to capture information related to the respiratory symptoms of COPD, i.e., breathlessness, cough, sputum production, chest congestion, and chest tightness. The ERS: COPD has a scoring range of 0 to 40, higher scores indicate more severe symptoms. |
| Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit or Hospitalization | From Baseline up to Week 104 | Annualized rate of exacerbations requiring ED Visit or Hospitalization (For pooled analysis across studies 222714 and 222725) will be assessed. |
| Annualized Rate of Severe Exacerbations | From Baseline up to Week 104 | 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. Annualized rate of severe exacerbations (For pooled analysis across studies 222714 and 222725) will be assessed. |
Countries
China, Japan, United States
Contacts
Primary ContactUS GSK Clinical Trials Call Center
Backup ContactEU GSK Clinical Trials Call Center
Outcome results
None listed