Recruiting

Dupilumab

Sponsor:

Sanofi

Code:

NCT07053423

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Dupilumab

Placebo

Study Details

Brief 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 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

Study ID

NCT07053423

Start date

Sep 22, 2025

Status verified date

Jun, 2026

Completion date

Feb 2, 2029

Anticipated

Primary completion date

Dec 23, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

218 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dupilumab

Subcutaneous injection as per protocol

placebo comparator: Placebo

Subcutaneous injection as per protocol

Interventions

Dupilumab

Pharmaceutical form:Solution for injection-Route of administration:SC injection

Placebo

Pharmaceutical form:Solution for injection-Route of administration:SC injection

Primary outcome measure

  • Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring) [ Time Frame: Baseline to Week 24 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610contact-us@sanofi.com

Locations

University of Alabama at Birmingham - School of Medicine- Site Number : 8400003

Recruiting

Birmingham, Alabama, United States, 35233

Finlay Medical Research- Site Number : 8400010

Recruiting

Miami, Florida, United States, 33126

Private Practice - Dr. David Kavtaradze- Site Number : 8400017

Recruiting

Cordele, Georgia, United States, 31015

University of Kansas Medical Center- Site Number : 8400005

Recruiting

Kansas City, Kansas, United States, 66160

Johns Hopkins Bayview Medical Center- Site Number : 8400009

Recruiting

Baltimore, Maryland, United States, 21224

Brigham & Women's Hospital- Site Number : 8400014

Recruiting

Boston, Massachusetts, United States, 02115

American Health Research - Charlotte- Site Number : 8400013

Recruiting

Charlotte, North Carolina, United States, 28277

Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400004

Recruiting

Winston-Salem, North Carolina, United States, 27103

Clinical Research Associates of Central Pennsylvania- Site Number : 8400002

Recruiting

DuBois, Pennsylvania, United States, 15801

REX Clinical Trials - Beaumont- Site Number : 8400011

Recruiting

Beaumont, Texas, United States, 77701

Investigational Site Number : 1240002

Recruiting

London, Ontario, Canada, N6A 5B7

More Information

Sponsor

Sanofi

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sanofi on 2026-06-12.