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Depemokimab as an Extended treatmeNt DURation biologic in Adults with COPD and type 2 inflammation

Pulmonology
Lillian Chow
A Randomized, double-blind, placebo-controlled, parallel group, multicenter studies of the efficacy and safety of depemokimab in adult participants with COPD with type 2 inflammation characterized by an eosinophilic phenotype
Lung - Pulmonary

Study Description

Eligibility

  1. Participants must be greater than or equal to (greater than or equal to) 40 to less than or equal to (less than or equal to) 80 years of age, at the time of signing the informed consent.
  2. Elevated blood eosinophil count (BEC).
  3. Moderate to severe COPD with frequent exacerbations, defined as:
  4. A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year
  5. A post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio of less than (less than) 0.70 and a post- bronchodilator FEV1 greater than 30 percent (%) and less than or equal to 80% predicted normal values
  6. A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening
  7. COPD assessment test (CAT) score greater than or equal to 10 at Visit 1.
  8. Smoking status: Current or former cigarette smokers with a history of cigarette smoking of greater than or equal to10 pack-years.
  9. 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.
  10. Body mass index (BMI) greater than or equal to 16 kilogram per square meter (kg/m^2).
  11. Male or eligible female participants.

The following subjects are excluded:

  1. Participants with a current or prior physician diagnosis of asthma.
  2. Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease.
  3. Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1.
  4. Lung resection: Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure.
  5. Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1.
  6. Continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day.
  7. Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension
  8. Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure [BiPAP] or Continuous Positive Airway Pressure [CPAP]).
  9. Unstable cardiovascular disease or arrhythmia.
  10. Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1).
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