Itepekimab for COPD exacerbations
- Age between 40 and 85 years old.
- BMI of 18 kg/m2 or above.
- COPD Diagnosis for at least 1 year.
- Post-BD FEV1/FVC ratio of < 70%.
- Post-BD FEV1 > 20% and ≤ 80%.
- Either on Triple Therapy or at least LAMA/LABA.
- History of a chronic productive cough of at least 3 months in past year.
- 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.
- 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.)
- Former cigarette smokers cannot have been using vaping or any other active smoking products within the last 6 months prior to screening.
- 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 on greater than 2.0 L/min oxygen therapy (no restriction on oxygen use during night time).
- No other unstable and clinically significant diseases of other organ systems.
- No presence of parasitic infection, malignancies (within past 5 years), immunodeficiencies.
- Cannot be on any nonselective beta-1 adrenergic receptor blocker.
- Patient can not have been on PDE3/PDE4 inhibitors, macrolides, methylxanthines, cromones, in 6 months prior to screening.
- Cannot have previously been involved in itepekimab study.
- Known hypersensitivity to this drug.
- Cannot be currently on any other mAb therapies within 5 half-lives.
- Known or suspected continued abuse of alcohol or drugs.