NCT07053423RecruitingPhase 4
A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
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.
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 218 (estimated)
- First submitted
- 27 Jun 2025
- Start date
- 22 Sept 2025
- Primary completion date
- 23 Dec 2028
- Lead sponsor
- Sanofi
- Diseases
- COPD
- NCT number
- NCT07053423
- EudraCT number
- 2025-521268-37
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 218
- From 22 Sept 2025 to the primary completion date, 23 Dec 2028
- 85 sites in 22 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with oxygen \>4.0 L/min for ≥8 hours/day Respiratory tract infection within 4 weeks before screening, or during the screening period
- 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.
Other illness
- A current diagnosis of asthma according to the Global Initiative for Asthma diagnostic (GINA) guidelines, or documented history of asthma
Lab values
- 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
Other
- Diagnosis of α-1 anti-trypsin deficiency
Who the study is looking for
- 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
Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (85)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.