Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype
Inclusion
- Age between 40 and 80 years old.
- BMI of 18 kg/m2 to 40 kg/m2.
- Historical Blood Eosinophil Count of ≥150 cells/mcL.
- COPD Diagnosis for at least 1 year.
- Post-BD FEV1/FVC ratio of < 70%.
- Post-BD FEV1 > 20% and ≤ 70%.
- Either on Triple Therapy or at least LAMA/LABA.
- At least 2 moderate COPD exacerbations (requiring ICS) or 1 severe COPD exacerbation (requiring hospitalization) in the past 12 months.
- Current or Former Smoker of 10 or more pack-years.
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 above 4 L/min.
- No use of CPAP or BiPAP machines.
- Major surgery within 8 weeks of screening.
- Acute Myocardial Infarction within 6 months of screening.
- Heart Failure of Class III or IV per NYHA standards.
- Any arrhythmias or fibrillation of the heart.
- No live or attenuated vaccinations within 12 weeks of screening.
- No use of Azithromycin or other long-term macrolide therapies unless on for more than 6 months. The same goes for Roflumilast.
- No other unstable and clinically significant diseases of other organ systems.
- No presence of parasitic infection, malignancies, immunodeficiencies.
- Known hypersensitivity to any biologic therapy.
- Cannot be currently on any other mAb therapies within 5 half-lives.
- Known or suspected continued abuse of alcohol or drugs.