Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
Change from baseline in itepekimab pharmacodynamic normalized enrichment score (NES) derived from former smokers in endobronchial biopsies in current smokers with COPD, Change from baseline in itepekimab pharmacodynamics NES derived from former smokers in bronchial brushings in current smokers with COPD, Change from baseline in itepekimab pharmacodynamics NES derived from former smokers in nasal brushings in current smokers with COPD
Detailed description
Change from baseline in IL-33 treated eosinophil-associated NES in endobronchial biopsies, Change from baseline in IL-33 treated mast cell-associated NES in endobronchial biopsies, Change from baseline in blood eosinophil count, Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interests (AESIs), serious adverse events (SAEs), and adverse events (AEs) leading to permanent treatment discontinuation, Incidence of potentially clinically significant abnormalities in clinical laboratory tests, vital signs and electrocardiogram (ECG) abnormalities in the treatment-emergent period, Incidence of treatment-emergent anti-itepekimab antibody responses throughout the study, Functional itepekimab concentrations in serum
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in itepekimab pharmacodynamic normalized enrichment score (NES) derived from former smokers in endobronchial biopsies in current smokers with COPD, Change from baseline in itepekimab pharmacodynamics NES derived from former smokers in bronchial brushings in current smokers with COPD, Change from baseline in itepekimab pharmacodynamics NES derived from former smokers in nasal brushings in current smokers with COPD | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in IL-33 treated eosinophil-associated NES in endobronchial biopsies, Change from baseline in IL-33 treated mast cell-associated NES in endobronchial biopsies, Change from baseline in blood eosinophil count, Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interests (AESIs), serious adverse events (SAEs), and adverse events (AEs) leading to permanent treatment discontinuation, Incidence of potentially clinically significant abnormalities in clinical laboratory tests, vital signs and electrocardiogram (ECG) abnormalities in the treatment-emergent period, Incidence of treatment-emergent anti-itepekimab antibody responses throughout the study, Functional itepekimab concentrations in serum | — |
Countries
Belgium, Denmark, Germany, Netherlands