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A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
Sponsor: Sanofi
Summary
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.
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Mucus Plugging and Other Lung Imaging Parameters in Patients With Chronic Obstructive Pulmonary Disease.
Key Details
Gender
All
Age Range
40 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
218
Start Date
2025-09-22
Completion Date
2029-02-15
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
Dupilumab
Pharmaceutical form:Solution for injection-Route of administration:SC injection
Placebo
Pharmaceutical form:Solution for injection-Route of administration:SC injection
Locations (53)
University of Alabama at Birmingham - School of Medicine- Site Number : 8400003
Birmingham, Alabama, United States
Finlay Medical Research- Site Number : 8400010
Miami, Florida, United States
Johns Hopkins Bayview Medical Center- Site Number : 8400009
Baltimore, Maryland, United States
American Health Research - Charlotte- Site Number : 8400013
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400004
Winston-Salem, North Carolina, United States
Clinical Research Associates of Central PA- Site Number : 8400002
DuBois, Pennsylvania, United States
REX Clinical Trials - Beaumont- Site Number : 8400011
Beaumont, Texas, United States
Investigational Site Number : 0320001
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320002
Buenos Aires, Argentina
Investigational Site Number : 0320003
Buenos Aires, Argentina
Associacao Proar- Site Number : 0760005
Salvador, Estado de Bahia, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760002
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760006
São Paulo, Brazil
Incor - Instituto do Coracao- Site Number : 0760001
São Paulo, Brazil
Investigational Site Number : 1560001
Guangzhou, China
Investigational Site Number : 2080003
Aalborg, Denmark
Investigational Site Number : 2080002
Vejle, Denmark
Investigational Site Number : 2500008
La Tronche, France
Investigational Site Number : 2500001
Lille, France
Investigational Site Number : 2500005
Lyon, France
Investigational Site Number : 2500006
Marseille, France
Investigational Site Number : 2500002
Montpellier, France
Investigational Site Number : 2500003
Pessac, France
Investigational Site Number : 2500004
Reims, France
Investigational Site Number : 3480003
Debrecen, Hungary
Investigational Site Number : 3480001
Hajdúnánás, Hungary
Investigational Site Number : 3480002
Pécs, Hungary
Investigational Site Number : 3800001
Cona, Ferrara, Italy
Investigational Site Number : 3800004
Siena, Italy
Investigational Site Number : 5280001
Groningen, Netherlands
Investigational Site Number : 5280003
Hoofddorp, Netherlands
Investigational Site Number : 5280006
Nijmegen, Netherlands
Investigational Site Number : 6160001
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 6160003
Bialystok, Podlaskie Voivodeship, Poland
Investigational Site Number : 6160002
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
Investigational Site Number : 4100005
Anyang-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240005
Santander, Cantabria, Spain
Investigational Site Number : 7240002
Pozuelo de Alarcón, Madrid, Spain
Investigational Site Number : 7240004
Oviedo, Principality of Asturias, Spain
Investigational Site Number : 7240003
Madrid, Spain
Investigational Site Number : 7520002
Gothenburg, Sweden
Investigational Site Number : 7520003
Lund, Sweden
Investigational Site Number : 1580001
Kaohsiung City, Taiwan
Investigational Site Number : 1580002
Taipei, Taiwan
Investigational Site Number : 8260006
Newcastle upon Tyne, England, United Kingdom
Investigational Site Number : 8260008
Southampton, Hampshire, United Kingdom
Investigational Site Number : 8260003
Leicester, Leicestershire, United Kingdom
Investigational Site Number : 8260001
Bradford, United Kingdom