A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
Recruiting · NCT07053423 · Interventional (participants receive a specific treatment) · Lead sponsor: Sanofi
View the official record on ClinicalTrials.gov →Interventions studied
DupilumabPlacebo
What this trial is about
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.
Who can take part
Age range
40 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 9 US states.
- 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
- Private Practice - Dr. David Kavtaradze- Site Number : 8400017 - Cordele, Georgia, United States
- University of Kansas Medical Center- Site Number : 8400005 - Kansas City, Kansas, United States
- Johns Hopkins Bayview Medical Center- Site Number : 8400009 - Baltimore, Maryland, United States
- Brigham & Women's Hospital- Site Number : 8400014 - Boston, Massachusetts, 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 Pennsylvania- Site Number : 8400002 - DuBois, Pennsylvania, United States
- REX Clinical Trials - Beaumont- Site Number : 8400011 - Beaumont, Texas, United States
- Investigational Site Number : 2080003 - Aalborg, Denmark
- Investigational Site Number : 7560004 - Basel, Switzerland
- Investigational Site Number : 8260001 - Bradford, United Kingdom
- Investigational Site Number : 0320002 - Buenos Aires, Argentina
- Investigational Site Number : 0320003 - Buenos Aires, Argentina
- Investigational Site Number : 1560005 - Chengdu, China
- Investigational Site Number : 3480003 - Debrecen, Hungary
- Investigational Site Number : 7560002 - Geneva, Switzerland
- Investigational Site Number : 7520002 - Gothenburg, Sweden
- Investigational Site Number : 5280001 - Groningen, Netherlands
- Investigational Site Number : 1560001 - Guangzhou, China
- Investigational Site Number : 3480001 - Hajdúnánás, Hungary
- Investigational Site Number : 1560004 - Hangzhou, China
- Investigational Site Number : 5280003 - Hoofddorp, Netherlands
- Investigational Site Number : 1580001 - Kaohsiung City, Taiwan
- Investigational Site Number : 2500008 - La Tronche, France
- Investigational Site Number : 2500001 - Lille, France
- Investigational Site Number : 7520003 - Lund, Sweden
- Investigational Site Number : 2500005 - Lyon, France
- Investigational Site Number : 7240003 - Madrid, Spain
- Investigational Site Number : 2500006 - Marseille, France
- Investigational Site Number : 2500002 - Montpellier, France
- Investigational Site Number : 5280006 - Nijmegen, Netherlands
- Investigational Site Number : 2500003 - Pessac, France
- Investigational Site Number : 3480002 - Pécs, Hungary
- Investigational Site Number : 2500004 - Reims, France
- Investigational Site Number : 6820003 - Riyadh, Saudi Arabia
- Investigational Site Number : 5280002 - Rotterdam, Netherlands
- Investigational Site Number : 3800004 - Siena, Italy
- Investigational Site Number : 7020002 - Singapore, Singapore
- Investigational Site Number : 7020001 - Singapore, Singapore
- Investigational Site Number : 7560003 - Sion, Switzerland
- 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 : 1580002 - Taipei, Taiwan
- Investigational Site Number : 2080002 - Vejle, Denmark
- Investigational Site Number : 1560009 - Xiamen, China
- Investigational Site Number : 7240001 - Barcelona, Barcelona [Barcelona], Spain
- Investigational Site Number : 7240005 - Santander, Cantabria, Spain
- Investigational Site Number : 8260006 - Newcastle upon Tyne, England, United Kingdom
- Hospital Dom Pedro De Alcantara- Site Number : 0760009 - Feira de Santana, Estado de Bahia, Brazil
- Associacao Proar- Site Number : 0760005 - Salvador, Estado de Bahia, Brazil
- Investigational Site Number : 3800001 - Cona, Ferrara, Italy
- Investigational Site Number : 6160001 - Poznan, Greater Poland Voivodeship, Poland
- Investigational Site Number : 4100005 - Anyang-si, Gyeonggi-do, South Korea
- Investigational Site Number : 8260008 - Southampton, Hampshire, United Kingdom
- Investigational Site Number : 8260003 - Leicester, Leicestershire, United Kingdom
- Investigational Site Number : 7240002 - Pozuelo de Alarcón, Madrid, Spain
- Investigational Site Number : 1240002 - London, Ontario, Canada
- Investigational Site Number : 6160003 - Bialystok, Podlaskie Voivodeship, Poland
Showing 60 of 68 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →