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Clinical Trials in the UK / NCT07053423
Recruiting Phase 4

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

NCT07053423 · tracked via the Priya Life Science UK tracker
Sponsor
Sanofi
Phase
Phase 4
Started
2025-09-22
Last updated
2026-06-12

Condition(s) studied

Chronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

DupilumabPlacebo

Dupilumab: Pharmaceutical form:Solution for injection-Route of administration:SC injection

Placebo: Pharmaceutical form:Solution for injection-Route of administration:SC injection

Study 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

Sex
ALL
Min age
40 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (68)

FacilityCityRegionStatus
University of Alabama at Birmingham - School of Medicine- Site Number : 8400003 Birmingham Alabama Recruiting
Finlay Medical Research- Site Number : 8400010 Miami Florida Recruiting
Private Practice - Dr. David Kavtaradze- Site Number : 8400017 Cordele Georgia Recruiting
University of Kansas Medical Center- Site Number : 8400005 Kansas City Kansas Recruiting
Johns Hopkins Bayview Medical Center- Site Number : 8400009 Baltimore Maryland Recruiting
Brigham & Women's Hospital- Site Number : 8400014 Boston Massachusetts Recruiting
American Health Research - Charlotte- Site Number : 8400013 Charlotte North Carolina Recruiting
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400004 Winston-Salem North Carolina Recruiting
Clinical Research Associates of Central Pennsylvania- Site Number : 8400002 DuBois Pennsylvania Recruiting
REX Clinical Trials - Beaumont- Site Number : 8400011 Beaumont Texas Recruiting
Investigational Site Number : 0320001 San Miguel de Tucumán Tucumán Province Recruiting
Investigational Site Number : 0320002 Buenos Aires Argentina Recruiting
Investigational Site Number : 0320003 Buenos Aires Argentina Recruiting
Hospital Dom Pedro De Alcantara- Site Number : 0760009 Feira de Santana Estado de Bahia Recruiting
Associacao Proar- Site Number : 0760005 Salvador Estado de Bahia Recruiting
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760002 Porto Alegre Rio Grande do Sul Recruiting
Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760006 São Paulo Brazil Recruiting
Incor - Instituto do Coracao- Site Number : 0760001 São Paulo Brazil Recruiting
Investigational Site Number : 1240002 London Ontario Recruiting
Investigational Site Number : 1560005 Chengdu China Recruiting
Investigational Site Number : 1560001 Guangzhou China Recruiting
Investigational Site Number : 1560004 Hangzhou China Recruiting
Investigational Site Number : 1560009 Xiamen China Recruiting
Investigational Site Number : 2080003 Aalborg Denmark Recruiting
Investigational Site Number : 2080002 Vejle Denmark Recruiting
Investigational Site Number : 2500008 La Tronche France Recruiting
Investigational Site Number : 2500001 Lille France Recruiting
Investigational Site Number : 2500005 Lyon France Recruiting
Investigational Site Number : 2500006 Marseille France Recruiting
Investigational Site Number : 2500002 Montpellier France Recruiting
Investigational Site Number : 2500003 Pessac France Recruiting
Investigational Site Number : 2500004 Reims France Recruiting
Investigational Site Number : 3480003 Debrecen Hungary Recruiting
Investigational Site Number : 3480001 Hajdúnánás Hungary Recruiting
Investigational Site Number : 3480002 Pécs Hungary Recruiting
Investigational Site Number : 3800001 Cona Ferrara Recruiting
Investigational Site Number : 3800004 Siena Italy Recruiting
Investigational Site Number : 5280001 Groningen Netherlands Recruiting
Investigational Site Number : 5280003 Hoofddorp Netherlands Recruiting
Investigational Site Number : 5280006 Nijmegen Netherlands Recruiting

+ 28 more sites — see the full list on the official registry below.

On this site

📄 Dupixent (dupilumab) drug profile →

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07053423 on ClinicalTrials.gov ↗ ← All trials in the UK