eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation (VIGILANT)
Inclusion and exclusion criteria:
- Inclusion:
- Age between 40 and 75 years old.
- BMI of 16 kg/m2 or above.
- Historical Blood Eosinophil Count of ≥300 cells/mcL in last year. Requires at least 270 cells/mcL at Visit 1.
- COPD Diagnosis for at least 1 year.
- Post-BD FEV1/FVC ratio of < 70%.
- Post-BD FEV1 > 30% and ≤ 80%.
- Any kind of double or triple therapy stable for at least 3 months.
- One moderate COPD exacerbation (requiring ICS) and no more within the past 12 months.
- Should have evidence of other risk factors (e.g., CAT score of 15 or higher, FEV1 < 50%, Chronic Bronchitis, etc.)
- Current or Former Smoker of 10 or more pack-years.
- Signed ICF (Informed Consent Form).
- Exclusion:
- Must not have asthma diagnosis.
- No other clinically significant lung diseases besides COPD (e.g., sarcoidosis of the lung, Pulmonary HTN, lung fibrosis, lung cancer, ILD, etc.)
- No pneumonia, COPD exacerbation, or LRTIs within 4 weeks of screening.
- No lung resection ever.
- Cannot be within acute phase of pulmonary rehab within 4 weeks.
- Cannot be using continuous oxygen therapy for more than 12 hours/day.
- No use of CPAP or BiPAP machines.
- No other unstable and clinically significant diseases of other organ systems.
- No presence of parasitic infection, malignancies, immunodeficiencies.
- Known hypersensitivity to Depemokimab.
- Cannot be currently on any other mAb therapies within 5 half-lives.
- Known or suspected continued abuse of alcohol or drugs.
- No use of oral corticosteroids in the last 4 weeks prior to screening