Actively Recruiting

Phase 4
Age: 40Years - 85Years
All Genders
NCT07053423

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

Led by Sanofi · Updated on 2026-04-23

218

Participants Needed

58

Research Sites

184 weeks

Total Duration

On this page

Sponsors

S

Sanofi

Lead Sponsor

R

Regeneron Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Physician diagnosis of chronic obstructive pulmonary disease (COPD)
  • Current or former smokers with at least 10 pack-years smoking history
  • Moderate-to-severe COPD with post-bronchodilator FEV1/FVC ratio less than 0.70 and post-bronchodilator FEV1 between 30% and 70% predicted
  • Medical Research Council Dyspnea Scale grade 2 or higher or COPD assessment test (CAT) score of 10 or higher
  • Classified as GOLD category E with frequent or severe exacerbations
  • On stable background triple therapy (ICS + LABA + LAMA) for at least 3 months before randomization or dual therapy (LABA + LAMA) if ICS contraindicated
  • Evidence of Type 2 inflammation with blood eosinophils ≥300 cells/µL at screening or ≥150 cells/µL at screening plus history of ≥300 cells/µL in past year
  • Mucus score of 3 or higher
Not Eligible

You will not qualify if you...

  • Current diagnosis or documented history of asthma
  • Significant lung diseases other than COPD such as lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, or Churg-Strauss Syndrome
  • Diseases associated with elevated blood eosinophils not related to COPD
  • Use of oxygen therapy over 4.0 L/min for 8 or more hours per day
  • Respiratory tract infection within 4 weeks before or during screening
  • Diagnosis of alpha-1 anti-trypsin deficiency
  • Use of biologic therapies including experimental treatments or dupilumab
  • Use of mucolytic treatments unless stable for more than 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 58 locations

1

University of Alabama at Birmingham - School of Medicine- Site Number : 8400003

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Finlay Medical Research- Site Number : 8400010

Miami, Florida, United States, 33126

Actively Recruiting

3

Johns Hopkins Bayview Medical Center- Site Number : 8400009

Baltimore, Maryland, United States, 21224

Actively Recruiting

4

American Health Research - Charlotte- Site Number : 8400013

Charlotte, North Carolina, United States, 28277

Actively Recruiting

5

Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400004

Winston-Salem, North Carolina, United States, 27103

Actively Recruiting

6

Clinical Research Associates of Central PA- Site Number : 8400002

DuBois, Pennsylvania, United States, 15801

Actively Recruiting

7

REX Clinical Trials - Beaumont- Site Number : 8400011

Beaumont, Texas, United States, 77701

Actively Recruiting

8

Investigational Site Number : 0320001

San Miguel de Tucumán, Tucumán Province, Argentina, 4000

Actively Recruiting

9

Investigational Site Number : 0320002

Buenos Aires, Argentina, 1006

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10

Investigational Site Number : 0320003

Buenos Aires, Argentina, 1128

Actively Recruiting

11

Associacao Proar- Site Number : 0760005

Salvador, Estado de Bahia, Brazil, 40060-330

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12

Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760002

Porto Alegre, Rio Grande do Sul, Brazil, 90610-000

Actively Recruiting

13

Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760006

São Paulo, Brazil, 01323-001

Actively Recruiting

14

Incor - Instituto do Coracao- Site Number : 0760001

São Paulo, Brazil, 05403-900

Actively Recruiting

15

Investigational Site Number : 1240002

London, Ontario, Canada, N6A 5B7

Actively Recruiting

16

Investigational Site Number : 1560005

Chengdu, China, 610041

Actively Recruiting

17

Investigational Site Number : 1560001

Guangzhou, China, 510163

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18

Investigational Site Number : 1560004

Hangzhou, China, 310009

Actively Recruiting

19

Investigational Site Number : 2080003

Aalborg, Denmark, 9000

Actively Recruiting

20

Investigational Site Number : 2080002

Vejle, Denmark, 7100

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21

Investigational Site Number : 2500008

La Tronche, France, 38700

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22

Investigational Site Number : 2500001

Lille, France, 59037

Actively Recruiting

23

Investigational Site Number : 2500005

Lyon, France, 69004

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24

Investigational Site Number : 2500006

Marseille, France, 13915

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25

Investigational Site Number : 2500002

Montpellier, France, 34090

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26

Investigational Site Number : 2500003

Pessac, France, 33604

Actively Recruiting

27

Investigational Site Number : 2500004

Reims, France, 51092

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28

Investigational Site Number : 3480003

Debrecen, Hungary, 4032

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29

Investigational Site Number : 3480001

Hajdúnánás, Hungary, 4080

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30

Investigational Site Number : 3480002

Pécs, Hungary, 7635

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31

Investigational Site Number : 3800001

Cona, Ferrara, Italy, 44124

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32

Investigational Site Number : 3800004

Siena, Italy, 53100

Actively Recruiting

33

Investigational Site Number : 5280001

Groningen, Netherlands, 9713 GR

Actively Recruiting

34

Investigational Site Number : 5280003

Hoofddorp, Netherlands, 2134 TM

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35

Investigational Site Number : 5280006

Nijmegen, Netherlands, 6525 GA

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36

Investigational Site Number : 6160001

Poznan, Greater Poland Voivodeship, Poland, 60-693

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37

Investigational Site Number : 6160003

Bialystok, Podlaskie Voivodeship, Poland, 15-044

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38

Investigational Site Number : 6160002

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400

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39

Investigational Site Number : 7020002

Singapore, Singapore, 308433

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40

Investigational Site Number : 7020001

Singapore, Singapore, 529889

Actively Recruiting

41

Investigational Site Number : 4100005

Anyang-si, Gyeonggi-do, South Korea, 14068

Actively Recruiting

42

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, South Korea, 05030

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43

Investigational Site Number : 4100004

Seoul, Seoul-teukbyeolsi, South Korea, 05355

Actively Recruiting

44

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, South Korea, 06591

Actively Recruiting

45

Investigational Site Number : 4100003

Seoul, Seoul-teukbyeolsi, South Korea, 07061

Actively Recruiting

46

Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona], Spain, 08017

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47

Investigational Site Number : 7240005

Santander, Cantabria, Spain, 39008

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48

Investigational Site Number : 7240002

Pozuelo de Alarcón, Madrid, Spain, 28223

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49

Investigational Site Number : 7240004

Oviedo, Principality of Asturias, Spain, 33011

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50

Investigational Site Number : 7240003

Madrid, Spain, 28040

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51

Investigational Site Number : 7520002

Gothenburg, Sweden, 413 45

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52

Investigational Site Number : 7520003

Lund, Sweden, 221 85

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53

Investigational Site Number : 1580001

Kaohsiung City, Taiwan, 807

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54

Investigational Site Number : 1580002

Taipei, Taiwan, 10016

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55

Investigational Site Number : 8260006

Newcastle upon Tyne, England, United Kingdom, NE2 4HH

Actively Recruiting

56

Investigational Site Number : 8260008

Southampton, Hampshire, United Kingdom, SO16 6YD

Actively Recruiting

57

Investigational Site Number : 8260003

Leicester, Leicestershire, United Kingdom, LE1 5WW

Actively Recruiting

58

Investigational Site Number : 8260001

Bradford, United Kingdom, BD9 6RJ

Actively Recruiting

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Research Team

T

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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