A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
Sanofi · with Regeneron Pharmaceuticals · NCT07053423
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 40–85 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 4
- Target enrollment
- 218
- US sites recruiting
- 11
- Study start
- September 22, 2025
- Record last updated
- October 20, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Dupilumab; Placebo
Conditions: Chronic Obstructive Pulmonary Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
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
Exclusion Criteria
- 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.
Recruiting US locations
University of Alabama at Birmingham - School of Medicine- Site Number : 8400003
Birmingham, AL 35233
University of Miami Dermatology Clinical Trials Unit- Site Number : 8400015
Miami, FL 33125
Finlay Medical Research- Site Number : 8400010
Miami, FL 33126
Private Practice - Dr. David Kavtaradze- Site Number : 8400017
Cordele, GA 31015
University of Kansas Medical Center- Site Number : 8400005
Kansas City, KS 66160
Johns Hopkins Bayview Medical Center- Site Number : 8400009
Baltimore, MD 21224
Brigham & Women's Hospital- Site Number : 8400014
Boston, MA 02115
American Health Research - Charlotte- Site Number : 8400013
Charlotte, NC 28277
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400004
Winston-Salem, NC 27103
Clinical Research Associates of Central Pennsylvania- Site Number : 8400002
DuBois, PA 15801
REX Clinical Trials - Beaumont- Site Number : 8400011
Beaumont, TX 77701
Study contacts (from the official record)
- Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · contact-us@sanofi.com