A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.

NCT07053423 | Recruiting Phase 4 FDA Drug

• 3 other identifiers: LPS185832025-521268-37U1111-1314-5262
• Study Type: interventional
• Target: 218
• Locations: 17 countries
• Sites: 58

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 24

Secondary Outcomes (5)

• Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT)

  Baseline to Week 24

• Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT

  Baseline to Week 24

• Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT)

  Baseline to Week 24

• Change from baseline to Week 24 in Reactance area (AX) measured by FOT

  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

  Baseline to Week 36

Study Arms (2)

Dupilumab

EXPERIMENTAL

Subcutaneous injection as per protocol

Drug: Dupilumab

Placebo

PLACEBO COMPARATOR

Subcutaneous injection as per protocol

Drug: Placebo

Interventions

Dupilumab DRUG

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

Also known as: SAR231893, Dupixent

Dupilumab

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (58)

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

Birmingham, Alabama, 35233, United States

RECRUITING

Finlay Medical Research- Site Number : 8400010

Miami, Florida, 33126, United States

RECRUITING

Johns Hopkins Bayview Medical Center- Site Number : 8400009

Baltimore, Maryland, 21224, United States

RECRUITING

American Health Research - Charlotte- Site Number : 8400013

Charlotte, North Carolina, 28277, United States

RECRUITING

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

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Clinical Research Associates of Central PA- Site Number : 8400002

DuBois, Pennsylvania, 15801, United States

RECRUITING

REX Clinical Trials - Beaumont- Site Number : 8400011

Beaumont, Texas, 77701, United States

RECRUITING

Investigational Site Number : 0320001

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

RECRUITING

Investigational Site Number : 0320002

Buenos Aires, 1006, Argentina

RECRUITING

Investigational Site Number : 0320003

Buenos Aires, 1128, Argentina

RECRUITING

Associacao Proar- Site Number : 0760005

Salvador, Estado de Bahia, 40060-330, Brazil

RECRUITING

Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760002

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

RECRUITING

Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760006

São Paulo, 01323-001, Brazil

RECRUITING

Incor - Instituto do Coracao- Site Number : 0760001

São Paulo, 05403-900, Brazil

RECRUITING

Investigational Site Number : 1240002

London, Ontario, N6A 5B7, Canada

RECRUITING

Investigational Site Number : 1560005

Chengdu, 610041, China

RECRUITING

Investigational Site Number : 1560001

Guangzhou, 510163, China

RECRUITING

Investigational Site Number : 1560004

Hangzhou, 310009, China

RECRUITING

Investigational Site Number : 2080003

Aalborg, 9000, Denmark

RECRUITING

Investigational Site Number : 2080002

Vejle, 7100, Denmark

RECRUITING

Investigational Site Number : 2500008

La Tronche, 38700, France

RECRUITING

Investigational Site Number : 2500001

Lille, 59037, France

RECRUITING

Investigational Site Number : 2500005

Lyon, 69004, France

RECRUITING

Investigational Site Number : 2500006

Marseille, 13915, France

RECRUITING

Investigational Site Number : 2500002

Montpellier, 34090, France

RECRUITING

Investigational Site Number : 2500003

Pessac, 33604, France

RECRUITING

Investigational Site Number : 2500004

Reims, 51092, France

RECRUITING

Investigational Site Number : 3480003

Debrecen, 4032, Hungary

RECRUITING

Investigational Site Number : 3480001

Hajdúnánás, 4080, Hungary

RECRUITING

Investigational Site Number : 3480002

Pécs, 7635, Hungary

RECRUITING

Investigational Site Number : 3800001

Cona, Ferrara, 44124, Italy

RECRUITING

Investigational Site Number : 3800004

Siena, 53100, Italy

RECRUITING

Investigational Site Number : 5280001

Groningen, 9713 GR, Netherlands

RECRUITING

Investigational Site Number : 5280003

Hoofddorp, 2134 TM, Netherlands

RECRUITING

Investigational Site Number : 5280006

Nijmegen, 6525 GA, Netherlands

RECRUITING

Investigational Site Number : 6160001

Poznan, Greater Poland Voivodeship, 60-693, Poland

RECRUITING

Investigational Site Number : 6160003

Bialystok, Podlaskie Voivodeship, 15-044, Poland

RECRUITING

Investigational Site Number : 6160002

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland

RECRUITING

Investigational Site Number : 7020002

Singapore, 308433, Singapore

RECRUITING

Investigational Site Number : 7020001

Singapore, 529889, Singapore

RECRUITING

Investigational Site Number : 4100005

Anyang-si, Gyeonggi-do, 14068, South Korea

RECRUITING

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 05030, South Korea

RECRUITING

Investigational Site Number : 4100004

Seoul, Seoul-teukbyeolsi, 05355, South Korea

RECRUITING

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, 06591, South Korea

RECRUITING

Investigational Site Number : 4100003

Seoul, Seoul-teukbyeolsi, 07061, South Korea

RECRUITING

Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona], 08017, Spain

RECRUITING

Investigational Site Number : 7240005

Santander, Cantabria, 39008, Spain

RECRUITING

Investigational Site Number : 7240002

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

Investigational Site Number : 7240004

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Investigational Site Number : 7240003

Madrid, 28040, Spain

RECRUITING

Investigational Site Number : 7520002

Gothenburg, 413 45, Sweden

RECRUITING

Investigational Site Number : 7520003

Lund, 221 85, Sweden

RECRUITING

Investigational Site Number : 1580001

Kaohsiung City, 807, Taiwan

RECRUITING

Investigational Site Number : 1580002

Taipei, 10016, Taiwan

RECRUITING

Investigational Site Number : 8260006

Newcastle upon Tyne, England, NE2 4HH, United Kingdom

RECRUITING

Investigational Site Number : 8260008

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

Investigational Site Number : 8260003

Leicester, Leicestershire, LE1 5WW, United Kingdom

RECRUITING

Investigational Site Number : 8260001

Bradford, BD9 6RJ, United Kingdom

RECRUITING

Related Links

• LPS18583 Plain Language Results Summary

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): December 23, 2028
• Study Completion (Estimated): April 4, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (3); SE (2); BR (4); NL (3); HU (3); IT (2); FR (7); PL (3); KR (5); DK (2); AR (3); GB (4); ES (5); TW (2); US (7); CA (1); SG (2)