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 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.
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.
You may qualify to participate in this study if you:
- Are greater than or equal to (>=) 40 to less than or equal to (<=) 80 years of age, at the time of signing the informed consent.
- Have elevated blood eosinophil count (BEC).
- Have 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
- Have a COPD assessment test (CAT) score >=10 at Visit 1.
- Are a current or former cigarette smoker with a history of cigarette smoking of >=10 pack-years.
- Are on an 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.
- Have a body mass index (BMI) >=16 kilogram per square meter (kg/m^2).
You may not qualify to participate if you:
- Have a current or prior physician diagnosis of asthma.
- 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 any pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1.
- Have had a lung resection: Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure.
- Have had a pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1.
- Require continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day.
- Have experienced cor pulmonale – resulting in right heart failure, severe pulmonary hypertension
- Suffer from chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure [BiPAP] or Continuous Positive Airway Pressure [CPAP]).
- Experience unstable cardiovascular disease or arrhythmia.
- Have any parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1).
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.
