A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40… (NCT07053423) | Clinical Trial Compass
RecruitingPhase 4
A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
United States218 participantsStarted 2025-09-22
Plain-language 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.
Who can participate
Age range40 Years – 85 Years
SexALL
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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 \>…
What they're measuring
1
Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring)
Timeframe: Baseline to Week 24
Trial details
NCT IDNCT07053423
SponsorSanofi
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-12-23
Contact for this trial
Trial Transparency email recommended (Toll free for US & Canada)