Chronic Obstructive Pulmonary DiseasePhase 4AEOLUSNCT07053423
A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
A Phase 4 study testing Dupilumab in people with Chronic Obstructive Pulmonary Disease, run by Sanofi at 85 sites in 22 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 85 sitesin 22 countries
- Study dates
- 22 Sep 2025to 2 Feb 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
85 sites in 22 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
85 sites in 22 countries
United States11 sites, 11 recruiting
- Recruiting
Johns Hopkins Bayview Medical Center- Site Number : 8400009
Baltimore, Maryland, 21224
- Recruiting
REX Clinical Trials - Beaumont- Site Number : 8400011
Beaumont, Texas, 77701
- Recruiting
University of Alabama at Birmingham - School of Medicine- Site Number : 8400003
Birmingham, Alabama, 35233
- Recruiting
Brigham & Women's Hospital- Site Number : 8400014
Boston, Massachusetts, 02115
- Recruiting
American Health Research - Charlotte- Site Number : 8400013
Charlotte, North Carolina, 28277
- Recruiting
Private Practice - Dr. David Kavtaradze- Site Number : 8400017
Cordele, Georgia, 31015
- Recruiting
Clinical Research Associates of Central Pennsylvania- Site Number : 8400002
DuBois, Pennsylvania, 15801
- Recruiting
University of Kansas Medical Center- Site Number : 8400005
Kansas City, Kansas, 66160
- Recruiting
University of Miami Dermatology Clinical Trials Unit- Site Number : 8400015
Miami, Florida, 33125
- Recruiting
Finlay Medical Research- Site Number : 8400010
Miami, Florida, 33126
- Recruiting
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400004
Winston-Salem, North Carolina, 27103
China7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 1560005
Chengdu, 610041
- Recruiting
Investigational Site Number : 1560013
Guangzhou, 510000
- Recruiting
Investigational Site Number : 1560001
Guangzhou, 510163
- Recruiting
Investigational Site Number : 1560004
Hangzhou, 310009
- Recruiting
Investigational Site Number : 1560010
Harbin, 150001
- Recruiting
Investigational Site Number : 1560012
Ningbo, 315010
- Recruiting
Investigational Site Number : 1560009
Xiamen, 361004
France7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 2500008
La Tronche, 38700
- Recruiting
Investigational Site Number : 2500001
Lille, 59037
- Recruiting
Investigational Site Number : 2500005
Lyon, 69004
- Recruiting
Investigational Site Number : 2500006
Marseille, 13915
- Recruiting
Investigational Site Number : 2500002
Montpellier, 34090
- Recruiting
Investigational Site Number : 2500003
Pessac, 33604
- Recruiting
Investigational Site Number : 2500004
Reims, 51092
Brazil6 sites, 6 recruiting
- Recruiting
Hospital Dom Pedro De Alcantara- Site Number : 0760009
Feira de Santana, Estado de Bahia, 44001-032
- Recruiting
Clínica CLARE- Site Number : 0760004
Goiânia, Goiás, 74110 030
- Recruiting
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760002
Porto Alegre, Rio Grande do Sul, 90610-000
- Recruiting
Associacao Proar- Site Number : 0760005
Salvador, Estado de Bahia, 40060-330
- Recruiting
Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760006
São Paulo, 01323-001
- Recruiting
Incor - Instituto do Coracao- Site Number : 0760001
São Paulo, 05403-000
United Kingdom6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 8260001
Bradford, BD9 6DA
- Recruiting
Investigational Site Number : 8260002
Dundee, Dundee City, DD1 9SY
- Recruiting
Investigational Site Number : 8260003
Leicester, Leicestershire, LE1 5WW
- Recruiting
Investigational Site Number : 8260006
Newcastle upon Tyne, England, NE2 4HH
- Recruiting
Investigational Site Number : 8260009
Sheffield, S10 2jf
- Recruiting
Investigational Site Number : 8260008
Southampton, Hampshire, SO16 6YD
South Korea5 sites, 4 recruiting
- Recruiting
Investigational Site Number : 4100005
Anyang-si, Gyeonggi-do, 14068
- Recruiting
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, 05030
- Recruiting
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, 05355
- Completed
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, 06591
- Recruiting
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, 07061
Spain5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 7240001
Barcelona, Catalunya [Cataluña], 08017
- Recruiting
Investigational Site Number : 7240003
Madrid, 28040
- Recruiting
Investigational Site Number : 7240004
Oviedo, Principality of Asturias, 33011
- Recruiting
Investigational Site Number : 7240002
Pozuelo de Alarcón, Madrid, 28223
- Recruiting
Investigational Site Number : 7240005
Santander, Cantabria, 39008
Italy4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 3800001
Cona, Ferrara, 44124
- Recruiting
Investigational Site Number : 3800002
Giugliano in Campania, Napoli, 80014
- Recruiting
Investigational Site Number : 3800003
Orbassano, Torino, 10043
- Recruiting
Investigational Site Number : 3800004
Siena, 53100
Netherlands4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 5280001
Groningen, 9713 GR
- Recruiting
Investigational Site Number : 5280003
Hoofddorp, 2134 TM
- Recruiting
Investigational Site Number : 5280006
Nijmegen, 6525 GA
- Recruiting
Investigational Site Number : 5280002
Rotterdam, 3045 PM
Argentina3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 0320002
Buenos Aires, 1006
- Recruiting
Investigational Site Number : 0320003
Buenos Aires, 1128
- Recruiting
Investigational Site Number : 0320001
San Miguel de Tucumán, Tucumán Province, 4000
Hungary3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 3480003
Debrecen, 4032
- Recruiting
Investigational Site Number : 3480001
Hajdúnánás, 4080
- Recruiting
Investigational Site Number : 3480002
Pécs, 7635
Japan3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 3920003
Kyoto, 606-8507
- Recruiting
Investigational Site Number : 3920001
Osaka, 545-8586
- Recruiting
Investigational Site Number : 3920002
Ube, Yamaguchi, 755-8505
Poland3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 6160003
Bialystok, Podlaskie Voivodeship, 15-044
- Recruiting
Investigational Site Number : 6160002
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400
- Recruiting
Investigational Site Number : 6160001
Poznan, Greater Poland Voivodeship, 60-693
Singapore3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 7020003
Singapore, 169608
- Recruiting
Investigational Site Number : 7020002
Singapore, 308433
- Recruiting
Investigational Site Number : 7020001
Singapore, 529889
Switzerland3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 7560004
Basel, 4031
- Recruiting
Investigational Site Number : 7560002
Geneva, 1205
- Recruiting
Investigational Site Number : 7560003
Sion, 1951
Canada2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 1240005
Calgary, Alberta, T2N 4Z6
- Recruiting
Investigational Site Number : 1240002
London, Ontario, N6A 5B7
Denmark2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 2080003
Aalborg, 9000
- Recruiting
Investigational Site Number : 2080002
Vejle, 7100
Germany2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 2760003
Berlin, 12159
- Recruiting
Investigational Site Number : 2760001
Mainz, 55128
Sweden2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 7520002
Gothenburg, 413 45
- Recruiting
Investigational Site Number : 7520003
Lund, 221 85
Taiwan2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 1580001
Kaohsiung City, 80756
- Recruiting
Investigational Site Number : 1580002
Taipei, 100
Austria1 site, 1 recruiting
- Recruiting
Investigational Site Number : 0400005
Linz, 4020
Saudi Arabia1 site, 1 recruiting
- Recruiting
Investigational Site Number : 6820003
Riyadh, 11461
About this study
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.
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
- Chronic Obstructive Pulmonary Disease
- Being tested
- Dupilumab, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called SAR231893, Dupixent
Pharmaceutical form:Solution for injection-Route of administration:SC injection
PlaceboDrug
Pharmaceutical form:Solution for injection-Route of administration:SC injection
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | Subcutaneous injection as per protocol Receives: Drug: Dupilumab |
| Placebo | Placebo comparator | Subcutaneous injection as per protocol Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring)
The score is calculated by counting the number of bronchopulmonary segments which on CT scans contain at least one mucus plugs. The score ranges from 0 up to a maximum score of 18 corresponding to the 18 bronchopulmonary segments present in most people. In this system, a mucus plug is defined as a complete occlusion of the airway imaged at Total Lung Capacity (TLC). Higher scores indicate worse outcome.
Measured: Baseline to Week 24
Secondary outcomes (5)
Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT)
Measured: Baseline to Week 24
Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT
Measured: Baseline to Week 24
Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT)
Measured: Baseline to Week 24
Change from baseline to Week 24 in Reactance area (AX) measured by FOT
Measured: Baseline to Week 24
Incidence of Treatment-Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) including potentially clinically significant abnormalities
Measured: Baseline to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start22 Sep 2025
- Primary completion23 Dec 2028 (estimated)
- Study completion2 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053423
- Sponsor's protocol ID
- LPS18583
- Other IDs
- 2025-521268-37, U1111-1314-5262, 2025
- Acronym
- AEOLUS
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org