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 (COPD), 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 compared 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.
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 \< 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 and 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. George's 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 E-RS: 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
Argentina, Australia, Austria, Bulgaria, Czechia, Germany, Greece, Israel, Italy, Latvia, New Zealand, Romania, South Korea, United Kingdom, United States
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Outcome results
None listed