Actively Recruiting
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
Eligibility Criteria
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
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
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
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9
Investigational Site Number : 0320002
Buenos Aires, Argentina, 1006
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10
Investigational Site Number : 0320003
Buenos Aires, Argentina, 1128
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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
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13
Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760006
São Paulo, Brazil, 01323-001
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14
Incor - Instituto do Coracao- Site Number : 0760001
São Paulo, Brazil, 05403-900
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15
Investigational Site Number : 1240002
London, Ontario, Canada, N6A 5B7
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16
Investigational Site Number : 1560005
Chengdu, China, 610041
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17
Investigational Site Number : 1560001
Guangzhou, China, 510163
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18
Investigational Site Number : 1560004
Hangzhou, China, 310009
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19
Investigational Site Number : 2080003
Aalborg, Denmark, 9000
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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
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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
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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
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33
Investigational Site Number : 5280001
Groningen, Netherlands, 9713 GR
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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
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41
Investigational Site Number : 4100005
Anyang-si, Gyeonggi-do, South Korea, 14068
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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
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44
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea, 06591
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45
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, South Korea, 07061
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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
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56
Investigational Site Number : 8260008
Southampton, Hampshire, United Kingdom, SO16 6YD
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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
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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