About this study
Are you struggling with managing symptoms of Chronic Obstructive Pulmonary Disease (COPD)?
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.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your health to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others struggling with COPD, and whether it will be made widely available to all Canadians trying to manage this condition. Study volunteers are an important part of moving medical care forward.
Who may qualify
You may qualify if
- Are male or female
- Have a eosinophilic phenotype measured using Blood Eosinophil Count (BEC)
- Have 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
- Have an 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
- Are a current or former cigarette smoker with a history of cigarette smoking of >=10 pack-years at Screening.
- Are on 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
- Have a body mass index (BMI) >=16 kilograms per square meter (kg/m^2)
This study may not be a fit if
- Have COPD as 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
- Have any other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease.
- Have had more than one moderate exacerbation or severe exacerbation in the past 12 months prior to Visit 1
- Have had pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Visit 1
- Have a history of, or plan for lung volume reduction surgery/endobronchial valve procedure
- Are 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
- Require oxygen supplementation for COPD
Every study has additional criteria the research site will review with you.
What participation may involve
- Regular visits with the study team at no cost
- Study assessments and health monitoring throughout
- Check-ins between visits
- Informed consent before anything begins — questions welcome
What participants may receive
- Study-related care from a physician-led team
- Study assessments at no cost
- Reimbursement for reasonable travel, where applicable
Specifics vary by study and site, and are never a guarantee of benefit. Being in a study is not a substitute for regular medical care.
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