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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

Full criteria on ClinicalTrials.gov

Sites (85)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Buenos AiresArgentinaRecruiting
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Buenos AiresArgentinaRecruiting
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San Miguel de TucumánArgentinaRecruiting
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LinzAustriaRecruiting
Hospital Dom Pedro De Alcantara- Site Number : 0760009
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Feira de SantanaBrazilRecruiting
Clínica CLARE- Site Number : 0760004
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GoiâniaBrazilRecruiting
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760002
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Porto AlegreBrazilRecruiting
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SalvadorBrazilRecruiting
Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760006
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São PauloBrazilRecruiting
Incor - Instituto do Coracao- Site Number : 0760001
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São PauloBrazilRecruiting
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CalgaryCanadaRecruiting
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LondonCanadaRecruiting
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BaselSwitzerlandRecruiting
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GenevaSwitzerlandRecruiting
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SionSwitzerlandRecruiting
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ChengduChinaRecruiting
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GuangzhouChinaRecruiting
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GuangzhouChinaRecruiting
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HangzhouChinaRecruiting
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HarbinChinaRecruiting
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NingboChinaRecruiting
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XiamenChinaRecruiting
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BerlinGermanyRecruiting
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MainzGermanyRecruiting
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AalborgDenmarkRecruiting
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VejleDenmarkRecruiting
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BarcelonaSpainRecruiting
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MadridSpainRecruiting
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OviedoSpainRecruiting
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Pozuelo de AlarcónSpainRecruiting
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SantanderSpainRecruiting
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La TroncheFranceRecruiting
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LilleFranceRecruiting
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LyonFranceRecruiting
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MarseilleFranceRecruiting
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MontpellierFranceRecruiting
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PessacFranceRecruiting
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ReimsFranceRecruiting
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BradfordUnited KingdomRecruiting
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DundeeUnited KingdomRecruiting
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LeicesterUnited KingdomRecruiting
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Newcastle upon TyneUnited KingdomRecruiting
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SheffieldUnited KingdomRecruiting
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SouthamptonUnited KingdomRecruiting
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DebrecenHungaryRecruiting
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HajdúnánásHungaryRecruiting
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PécsHungaryRecruiting
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ConaItalyRecruiting
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Giugliano in CampaniaItalyRecruiting
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OrbassanoItalyRecruiting
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SienaItalyRecruiting
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KyotoJapanRecruiting
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OsakaJapanRecruiting
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UbeJapanRecruiting
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Anyang-siSouth KoreaRecruiting
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SeoulSouth KoreaRecruiting
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SeoulSouth KoreaRecruiting
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SeoulSouth KoreaRecruiting
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SeoulSouth KoreaCompleted
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GroningenNetherlandsRecruiting
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HoofddorpNetherlandsRecruiting
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NijmegenNetherlandsRecruiting
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RotterdamNetherlandsRecruiting
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BialystokPolandRecruiting
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Ostrowiec ŚwiętokrzyskiPolandRecruiting
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PoznanPolandRecruiting
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RiyadhSaudi ArabiaRecruiting
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GothenburgSwedenRecruiting
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LundSwedenRecruiting
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SingaporeSingaporeRecruiting
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SingaporeSingaporeRecruiting
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SingaporeSingaporeRecruiting
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Kaohsiung CityTaiwanRecruiting
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TaipeiTaiwanRecruiting
Johns Hopkins Bayview Medical Center- Site Number : 8400009
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BaltimoreUnited StatesRecruiting
REX Clinical Trials - Beaumont- Site Number : 8400011
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BeaumontUnited StatesRecruiting
University of Alabama at Birmingham - School of Medicine- Site Number : 8400003
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BirminghamUnited StatesRecruiting
Brigham & Women's Hospital- Site Number : 8400014
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BostonUnited StatesRecruiting
American Health Research - Charlotte- Site Number : 8400013
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CharlotteUnited StatesRecruiting
Private Practice - Dr. David Kavtaradze- Site Number : 8400017
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CordeleUnited StatesRecruiting
Clinical Research Associates of Central Pennsylvania- Site Number : 8400002
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DuBoisUnited StatesRecruiting
University of Kansas Medical Center- Site Number : 8400005
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Kansas CityUnited StatesRecruiting
Finlay Medical Research- Site Number : 8400010
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MiamiUnited StatesRecruiting
University of Miami Dermatology Clinical Trials Unit- Site Number : 8400015
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MiamiUnited StatesRecruiting
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400004
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Winston-SalemUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.