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NCT07053423PHASE4Recruiting

A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.

Sanofi

Start Date

9/22/2025

Completion Date

2/2/2029

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.

Eligibility Criteria

Age Range: 40 years to 85 years

Inclusion Criteria: Participants with a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD) who meet the following criteria at screening: * 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 * Background triple therapy (ICS + LABA + LAMA) for 3 months before randomization with a stable dose of medication for ≥1 month before Visit 1; dual therapy (LABA + LAMA) allowed if ICS is contraindicated * Evidence of Type 2 inflammation: Participants with blood eosinophils ≥300 cells/μL at screening or with blood eosinophils ≥150 cells/μL at Visit 1 (screening) and with a history of blood eosinophils ≥300 cells/μL within the past year during stable state (non-exacerbation). * Mucus score cutoff of ≥3 Exclusion Criteria: * 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 * Any biologic therapy (including experimental treatments and dupilumab) * Participants on treatment with mucolytics unless on stable therapy for \>6 months The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Interventions

DRUG

Dupilumab

DRUG

Placebo

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Conditions

Chronic Obstructive Pulmonary Disease

Locations

University of Alabama at Birmingham - School of Medicine- Site Number : 8400003

Birmingham, Alabama 35233

United States

Finlay Medical Research- Site Number : 8400010

Miami, Florida 33126

United States

Private Practice - Dr. David Kavtaradze- Site Number : 8400017

Cordele, Georgia 31015

United States

University of Kansas Medical Center- Site Number : 8400005

Kansas City, Kansas 66160

United States

Johns Hopkins Bayview Medical Center- Site Number : 8400009

Baltimore, Maryland 21224

United States

Brigham & Women's Hospital- Site Number : 8400014

Boston, Massachusetts 02115

United States

American Health Research - Charlotte- Site Number : 8400013

Charlotte, North Carolina 28277

United States

Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400004

Winston-Salem, North Carolina 27103

United States

Clinical Research Associates of Central Pennsylvania- Site Number : 8400002

DuBois, Pennsylvania 15801

United States

REX Clinical Trials - Beaumont- Site Number : 8400011

Beaumont, Texas 77701

United States

Investigational Site Number : 0320001

San Miguel de Tucumán, Tucumán Province 4000

Argentina

Investigational Site Number : 0320002

Buenos Aires, 1006

Argentina

Investigational Site Number : 0320003

Buenos Aires, 1128

Argentina

Hospital Dom Pedro De Alcantara- Site Number : 0760009

Feira de Santana, Estado de Bahia 44001-032

Brazil

Associacao Proar- Site Number : 0760005

Salvador, Estado de Bahia 40060-330

Brazil

Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760002

Porto Alegre, Rio Grande do Sul 90610-000

Brazil

Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760006

São Paulo, 01323-001

Brazil

Incor - Instituto do Coracao- Site Number : 0760001

São Paulo, 05403-900

Brazil

Investigational Site Number : 1240002

London, Ontario N6A 5B7

Canada

Investigational Site Number : 1560005

Chengdu, 610041

China

Investigational Site Number : 1560001

Guangzhou, 510163

China

Investigational Site Number : 1560004

Hangzhou, 310009

China

Investigational Site Number : 1560009

Xiamen, 361004

China

Investigational Site Number : 2080003

Aalborg, 9000

Denmark

Investigational Site Number : 2080002

Vejle, 7100

Denmark

Investigational Site Number : 2500008

La Tronche, 38700

France

Investigational Site Number : 2500001

Lille, 59037

France

Investigational Site Number : 2500005

Lyon, 69004

France

Investigational Site Number : 2500006

Marseille, 13915

France

Investigational Site Number : 2500002

Montpellier, 34090

France

Investigational Site Number : 2500003

Pessac, 33604

France

Investigational Site Number : 2500004

Reims, 51092

France

Investigational Site Number : 3480003

Debrecen, 4032

Hungary

Investigational Site Number : 3480001

Hajdúnánás, 4080

Hungary

Investigational Site Number : 3480002

Pécs, 7635

Hungary

Investigational Site Number : 3800001

Cona, Ferrara 44124

Italy

Investigational Site Number : 3800004

Siena, 53100

Italy

Investigational Site Number : 5280001

Groningen, 9713 GR

Netherlands

Investigational Site Number : 5280003

Hoofddorp, 2134 TM

Netherlands

Investigational Site Number : 5280006

Nijmegen, 6525 GA

Netherlands

Investigational Site Number : 5280002

Rotterdam, 3045 PM

Netherlands

Investigational Site Number : 6160001

Poznan, Greater Poland Voivodeship 60-693

Poland

Investigational Site Number : 6160003

Bialystok, Podlaskie Voivodeship 15-044

Poland

Investigational Site Number : 6160002

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship 27-400

Poland

Investigational Site Number : 6820003

Riyadh, 11461

Saudi Arabia

Investigational Site Number : 7020002

Singapore, 308433

Singapore

Investigational Site Number : 7020001

Singapore, 529889

Singapore

Investigational Site Number : 4100005

Anyang-si, Gyeonggi-do 14068

South Korea

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi 05030

South Korea

Investigational Site Number : 4100004

Seoul, Seoul-teukbyeolsi 05355

South Korea

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi 06591

South Korea

Investigational Site Number : 4100003

Seoul, Seoul-teukbyeolsi 07061

South Korea

Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona] 08017

Spain

Investigational Site Number : 7240005

Santander, Cantabria 39008

Spain

Investigational Site Number : 7240002

Pozuelo de Alarcón, Madrid 28223

Spain

Investigational Site Number : 7240004

Oviedo, Principality of Asturias 33011

Spain

Investigational Site Number : 7240003

Madrid, 28040

Spain

Investigational Site Number : 7520002

Gothenburg, 413 45

Sweden

Investigational Site Number : 7520003

Lund, 221 85

Sweden

Investigational Site Number : 7560004

Basel, 4031

Switzerland

Investigational Site Number : 7560002

Geneva, 1205

Switzerland

Investigational Site Number : 7560003

Sion, 1951

Switzerland

Investigational Site Number : 1580001

Kaohsiung City, 807

Taiwan

Investigational Site Number : 1580002

Taipei, 10016

Taiwan

Investigational Site Number : 8260006

Newcastle upon Tyne, England NE2 4HH

United Kingdom

Investigational Site Number : 8260008

Southampton, Hampshire SO16 6YD

United Kingdom

Investigational Site Number : 8260003

Leicester, Leicestershire LE1 5WW

United Kingdom

Investigational Site Number : 8260001

Bradford, BD9 6RJ

United Kingdom