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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
218
Pharmaceutical form:Solution for injection-Route of administration:SC injection
Pharmaceutical form:Solution for injection-Route of administration:SC injection
Finlay Medical Research- Site Number : 8400010
Miami, Florida, United States
RECRUITINGAmerican Health Research - Charlotte- Site Number : 8400013
Charlotte, North Carolina, United States
RECRUITINGClinical Research Associates of Central PA- Site Number : 8400002
DuBois, Pennsylvania, United States
RECRUITINGREX Clinical Trials - Beaumont- Site Number : 8400011
Beaumont, Texas, United States
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.
Time frame: Baseline to Week 24
Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT)
Time frame: Baseline to Week 24
Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT
Time frame: Baseline to Week 24
Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT)
Time frame: Baseline to Week 24
Change from baseline to Week 24 in Reactance area (AX) measured by FOT
Time frame: Baseline to Week 24
Incidence of Treatment-Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) including potentially clinically significant abnormalities
Time frame: Baseline to Week 36
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CONTACT
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Investigational Site Number : 0320001
San Miguel de Tucumán, Tucumán Province, Argentina
RECRUITINGInvestigational Site Number : 0320003
Buenos Aires, Argentina
RECRUITINGHospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760002
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGInvestigational Site Number : 2080003
Aalborg, Denmark
RECRUITINGInvestigational Site Number : 2080002
Vejle, Denmark
RECRUITINGInvestigational Site Number : 2500008
La Tronche, France
RECRUITING...and 36 more locations