LPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups. The purpose of this study is to assess the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive).
Study details include:
The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The number of visits will be 9.
Current or former smokers with a smoking history of ≥10 pack-years
Moderate-to-severe COPD (post-BD FEV1/FVC ratio <0.70 and post-BD FEV1 % predicted >30% and ≤70%)
Medical Research Council Dyspnea Scale grade ≥2 or COPD assessment test (CAT) score ≥10
Global Initiative for Chronic Obstructive Lung Disease (GOLD) category E , Frequent or severe exacerbations
A current diagnosis of asthma according to the Global Initiative for Asthma diagnostic (GINA) guidelines, or documented history of asthma
Significant pulmonary disease other than COPD (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts
Treatment with oxygen >4.0 L/min for ≥8 hours/day Respiratory tract infection within 4 weeks before screening, or during the screening period
Diagnosis of α-1 anti-trypsin deficiency
Parallel
Dupilumab
DrugPharmaceutical form:Solution for injection-Route of administration:SC injection
Placebo
DrugPharmaceutical form:Solution for injection-Route of administration:SC injection
Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring)
The score is calculated by counting the number of bronchopulmonary segments which on CT scans contain at least one mucus plugs. The score ranges from 0 up to a maximum score of 18 corresponding to the 18 bronchopulmonary segments present in most people. In this system, a mucus plug is defined as a complete occlusion of the airway imaged at Total Lung Capacity (TLC). Higher scores indicate worse outcome.
Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT)
Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT
Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT)
Change from baseline to Week 24 in Reactance area (AX) measured by FOT
Click on the lead sponsor to view all of their trials.
Sanofi
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
