A Phase 4 interventional study of Dupilumab and Placebo in Chronic Obstructive Pulmonary Disease, sponsored by Sanofi. Recruiting at 85 sites in 22 countries. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Sanofi · Phase 4, Interventional, and Treatment
Among 15 studies in Pulmonary Disease, Chronic Obstructive by Sanofi — 7 open to participants now, 7 under way, 3 of them phase 3. Pulmonary Disease, Chronic Obstructive · Sanofi.
Among the 15 studies in Pulmonary Disease, Chronic Obstructive by Sanofi, this one is the 10th largest by planned enrollment of the 12 interventional ones that give a count, is one of 4 that started in 2025, is the only one in phase 4, and was the 10th registered.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →7 of the 15 studies in Pulmonary Disease, Chronic Obstructive by Sanofi are open now, in 12 countries. Recruiting first, the newest first:
Sanofi · Sites in United States
Sanofi · Sites in France
Sanofi · Sites in United States, Argentina, Australia and 23 more countries
Sanofi · Sites in United States, Argentina, Belgium and 22 more countries
Sanofi · Sites in Germany
By country, each count listing its studies:
Of the 555 Pulmonary Disease, Chronic Obstructive studies recruiting now, 305 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 87 take healthy volunteers.
This study: 40 Years to 85 Years · all sexes · no healthy volunteers.
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15 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 4 started in 2025.
This study's planned enrollment of 218 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 937 across the 12 interventional studies, 350 across the 3 observational. Of the 8 that completed or were terminated, 6 (75%) have results posted.
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Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 15 studies in Pulmonary Disease, Chronic Obstructive by Sanofi, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with a physician diagnosis of (COPD) who meet the following criteria at screening:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subcutaneous injection as per protocol
Drug: Dupilumab
Subcutaneous injection as per protocol
Drug: Placebo
Pharmaceutical form:Solution for injection-Route of administration:SC injection
Also known as: SAR231893, Dupixent
Pharmaceutical form:Solution for injection-Route of administration:SC injection
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.
Time frame: Baseline to Week 24
Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT)
Time frame: Baseline to Week 24
Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT
Time frame: Baseline to Week 24
Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT)
Time frame: Baseline to Week 24
Change from baseline to Week 24 in Reactance area (AX) measured by FOT
Time frame: 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
Time frame: Baseline to Week 36
Not enrolling at this site — choose another above.
Plan to share: 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
Started Sep 2025 (actual). Primary completion is estimated for Dec 2028, 39 months after the start.
Of 71 industry-sponsored phase 4 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 22. This study's planned 39 months is above that.
Counting every sponsor, half of 157 studies reached it within 19 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Dupilumab
Pulmonary Disease, Chronic Obstructive →