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RecruitingPhase 4

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

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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
A Study to Investigate Airway Inflammation With Dupilumab… (NCT07053423) | Bored Studies