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Looking for participantsPhase4

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

Sponsor: Sanofi

NCT ID: NCT07053423

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Dupilumab (drug), Placebo (drug)
How long the study runs
Study runs about 41 months (dates as stated)
About the drug or intervention
Dupilumab — drug: Pharmaceutical form:Solution for injection-Route of administration:SC injection · Placebo — drug: Pharmaceutical form:Solution for injection-Route of administration:SC injection
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
40 Years to 85 Years
Who
All
Number of participants
218
Started
2025-09-22
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic obstructive pulmonary disease
  • • Phase4 - 218 participants
  • • LPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups

Who can take part?

  • • Ages 40 Years to 85 Years
  • • Diagnosed with chronic obstructive pulmonary disease

Where?

  • • Dundee - Investigational Site Number : 8260002
  • • Newcastle upon Tyne - Investigational Site Number : 8260006
  • • Southampton - Investigational Site Number : 8260008
  • • Leicester - Investigational Site Number : 8260003
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Chronic Obstructive Pulmonary Disease

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years - 85 Years
  • Who can join: All genders

What the study is looking for

  • ✓Participants with a physician diagnosis of Chronic Obstructive lung Disease (COPD) who meet the following...
  • ✓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

Who cannot take part

  • ✗A current diagnosis of asthma according to the Global Initiative for Asthma diagnostic (GINA) guidelines, or...
  • ✗Treatment with oxygen \>4.0 L/min for ≥8 hours/day Respiratory tract infection within 4 weeks before screening, or...
  • ✗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
See the full criteria
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 Is This Study? (6 UK sites)

Investigational Site Number : 8260002

Dundee DD1 9SY, United Kingdom

Recruiting

Investigational Site Number : 8260006

Newcastle upon Tyne NE2 4HH, United Kingdom

Recruiting

Investigational Site Number : 8260008

Southampton SO16 6YD, United Kingdom

Recruiting

Investigational Site Number : 8260003

Leicester LE1 5WW, United Kingdom

Recruiting

Investigational Site Number : 8260001

Bradford BD9 6DA, United Kingdom

Recruiting

Investigational Site Number : 8260009

Sheffield S10 2jf, United Kingdom

Recruiting

How to Get in Touch

Trial Transparency email recommended (Toll free for US & Canada)

Sponsor contact

CONTACT

800-633-1610 contact-us@sanofi.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09