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A Phase 2a, open-label, two-part study to evaluate the mechanism of action of itepekimab (anti-IL-33 mAb) on airway inflammation in patients with chronic obstructive pulmonary disease (COPD)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512007-39-00
Acronym
PDY16967
Enrollment
65
Registered
2024-05-15
Start date
2022-06-20
Completion date
2025-07-22
Last updated
2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

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

Sanofi-Aventis Recherche & Developpement
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026