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Taking people in SwitzerlandPhase 4

Tests dupilumab for airway inflammation in people with COPD

Compares dupilumab with placebo on airway inflammation in adults with COPD.

Key facts

Who runs it
Sanofi
Where
Basel, Geneva, and Sion, SwitzerlandSee the 3 sitesAlso in 21 other countries, 82 sites
Trial code
Registry title
A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
Status
Recruiting
Phase
Phase 4
People taking part
218 people, planned
Started
22 Sept 2025
Expected to end
2 Feb 2029
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Dupilumab
  • Placebo
Record updated
20 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 40 to 85 with moderate-to-severe COPD who smoke or used to smoke, have frequent or severe flare-ups, and have signs of type 2 inflammation.

Age
40 to 85 years
Sex
All sexes can join.
Disease stage
Moderate-to-severe COPD (post-BD FEV1/FVC ratio <0.70 and post-BD FEV1 % predicted >30% and ≤70%), GOLD category E with frequent or severe exacerbations, and a mucus score of ≥3.
Earlier treatment
Must have been on triple inhaled therapy (ICS + LABA + LAMA) for 3 months before randomization, with a stable dose for ≥1 month before Visit 1. Dual therapy (LABA + LAMA) is allowed if ICS is contraindicated. Must not have had any biologic therapy, including dupilumab.
Biomarker or test result
Blood eosinophils ≥300 cells/μL at screening, or ≥150 cells/μL at Visit 1 with a history of ≥300 cells/μL within the past year during a stable state.

Main reasons for not taking part

  • Current or past asthma
  • Other significant lung disease, such as lung fibrosis, sarcoidosis or bronchiectasis
  • Diagnosis of α-1 anti-trypsin deficiency
  • Any biologic therapy, including dupilumab
  • Respiratory tract infection within 4 weeks before screening or during the screening period

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Diagnosis of α-1 anti-trypsin deficiency

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 85 years old?

Where in Switzerland

Also in 21 other countries, 82 sites

  • BaselHospital not named in the registryTaking people
  • GenevaHospital not named in the registryTaking people
  • SionHospital not named in the registryTaking people

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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.

The 2 groups in the trial

  • DupilumabTreatment being tested

    Subcutaneous injection as per protocol

  • PlaceboPlacebo, for comparison

    Subcutaneous injection as per protocol

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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.
Plain-language title
Tests dupilumab for airway inflammation in people with COPDGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07053423, who can take part
Record updated
20 October 2026