A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
NCT ID: NCT07053423
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
218 participants
INTERVENTIONAL
2025-09-22
2029-02-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dupilumab
Subcutaneous injection as per protocol
Dupilumab
Pharmaceutical form:Solution for injection-Route of administration:SC injection
Placebo
Subcutaneous injection as per protocol
Placebo
Pharmaceutical form:Solution for injection-Route of administration:SC injection
Interventions
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Dupilumab
Pharmaceutical form:Solution for injection-Route of administration:SC injection
Placebo
Pharmaceutical form:Solution for injection-Route of administration:SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
40 Years
85 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Locations
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Finlay Medical Research- Site Number : 8400010
Miami, Florida, United States
American Health Research - Charlotte- Site Number : 8400013
Charlotte, North Carolina, United States
Clinical Research Associates of Central PA- Site Number : 8400002
DuBois, Pennsylvania, United States
REX Clinical Trials - Beaumont- Site Number : 8400011
Beaumont, Texas, United States
Investigational Site Number : 0320001
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320003
Buenos Aires, , Argentina
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760002
Porto Alegre, Rio Grande do Sul, Brazil
Investigational Site Number : 2080003
Aalborg, , Denmark
Investigational Site Number : 2080002
Vejle, , Denmark
Investigational Site Number : 2500001
Lille, , France
Investigational Site Number : 2500005
Lyon, , France
Investigational Site Number : 2500006
Marseille, , France
Investigational Site Number : 2500002
Montpellier, , France
Investigational Site Number : 2500003
Pessac, , France
Investigational Site Number : 2500004
Reims, , France
Investigational Site Number : 3480003
Debrecen, , Hungary
Investigational Site Number : 3480001
Hajdúnánás, , Hungary
Investigational Site Number : 3480002
Pécs, , Hungary
Investigational Site Number : 3800004
Siena, , Italy
Investigational Site Number : 5280001
Groningen, , Netherlands
Investigational Site Number : 6160001
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 6160003
Bialystok, Podlaskie Voivodeship, Poland
Investigational Site Number : 6160002
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240002
Pozuelo de Alarcón, Madrid, Spain
Investigational Site Number : 1580001
Kaohsiung City, , Taiwan
Investigational Site Number : 8260003
Leicester, Leicestershire, United Kingdom
Investigational Site Number : 8260001
Bradford, , United Kingdom
Investigational Site Number : 8260006
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
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LPS18583 Plain Language Results Summary
Other Identifiers
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2025-521268-37
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1314-5262
Identifier Type: REGISTRY
Identifier Source: secondary_id
LPS18583
Identifier Type: -
Identifier Source: org_study_id
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