Recruiting NCT07053423
A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dupilumab, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease. Basic parameters: 40 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Brazil, Canada, China +14
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Mucus Plugging and Other Lung Imaging Parameters in Patients With Chronic Obstructive Pulmonary Disease.
Overview
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.
Interventions
- Drug Dupilumab
Pharmaceutical form:Solution for injection-Route of administration:SC injection - Drug Placebo
Pharmaceutical form:Solution for injection-Route of administration:SC injection
Primary outcome measures
- Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring) [Time frame: Baseline to Week 24]
Secondary outcome measures (5)
- Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT) [Time frame: Baseline to Week 24]
- Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT [Time frame: Baseline to Week 24]
- Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT) [Time frame: Baseline to Week 24]
- Change from baseline to Week 24 in Reactance area (AX) measured by FOT [Time frame: 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 [Time frame: Baseline to Week 36]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 10 centers
- University of Alabama at Birmingham - School of Medicine- Site Number : 8400003 — Birmingham
- Finlay Medical Research- Site Number : 8400010 — Miami
- Private Practice - Dr. David Kavtaradze- Site Number : 8400017 — Cordele
- University of Kansas Medical Center- Site Number : 8400005 — Kansas City
- Johns Hopkins Bayview Medical Center- Site Number : 8400009 — Baltimore
- Brigham & Women's Hospital- Site Number : 8400014 — Boston
- American Health Research - Charlotte- Site Number : 8400013 — Charlotte
- Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400004 — Winston-Salem
- … and 2 more centers
France · 7 centers
- Investigational Site Number : 2500008 — La Tronche
- Investigational Site Number : 2500001 — Lille
- Investigational Site Number : 2500005 — Lyon
- Investigational Site Number : 2500006 — Marseille
- Investigational Site Number : 2500002 — Montpellier
- Investigational Site Number : 2500003 — Pessac
- Investigational Site Number : 2500004 — Reims
Brazil · 5 centers
- Hospital Dom Pedro De Alcantara- Site Number : 0760009 — Feira de Santana
- Associacao Proar- Site Number : 0760005 — Salvador
- Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760002 — Porto Alegre
- Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760006 — São Paulo
- Incor - Instituto do Coracao- Site Number : 0760001 — São Paulo
South Korea · 5 centers
- Investigational Site Number : 4100005 — Anyang-si
- Investigational Site Number : 4100001 — Seoul
- Investigational Site Number : 4100004 — Seoul
- Investigational Site Number : 4100002 — Seoul
- Investigational Site Number : 4100003 — Seoul
Spain · 5 centers
- Investigational Site Number : 7240001 — Barcelona
- Investigational Site Number : 7240005 — Santander
- Investigational Site Number : 7240002 — Pozuelo de Alarcón
- Investigational Site Number : 7240004 — Oviedo
- Investigational Site Number : 7240003 — Madrid
China · 4 centers
- Investigational Site Number : 1560005 — Chengdu
- Investigational Site Number : 1560001 — Guangzhou
- Investigational Site Number : 1560004 — Hangzhou
- Investigational Site Number : 1560009 — Xiamen
Netherlands · 4 centers
- Investigational Site Number : 5280001 — Groningen
- Investigational Site Number : 5280003 — Hoofddorp
- Investigational Site Number : 5280006 — Nijmegen
- Investigational Site Number : 5280002 — Rotterdam
United Kingdom · 4 centers
- Investigational Site Number : 8260006 — Newcastle upon Tyne
- Investigational Site Number : 8260008 — Southampton
- Investigational Site Number : 8260003 — Leicester
- Investigational Site Number : 8260001 — Bradford
Argentina · 3 centers
- Investigational Site Number : 0320001 — San Miguel de Tucumán
- Investigational Site Number : 0320002 — Buenos Aires
- Investigational Site Number : 0320003 — Buenos Aires
Hungary · 3 centers
- Investigational Site Number : 3480003 — Debrecen
- Investigational Site Number : 3480001 — Hajdúnánás
- Investigational Site Number : 3480002 — Pécs
Poland · 3 centers
- Investigational Site Number : 6160001 — Poznan
- Investigational Site Number : 6160003 — Bialystok
- Investigational Site Number : 6160002 — Ostrowiec Świętokrzyski
Switzerland · 3 centers
- Investigational Site Number : 7560004 — Basel
- Investigational Site Number : 7560002 — Geneva
- Investigational Site Number : 7560003 — Sion
Denmark · 2 centers
- Investigational Site Number : 2080003 — Aalborg
- Investigational Site Number : 2080002 — Vejle
Italy · 2 centers
- Investigational Site Number : 3800001 — Cona
- Investigational Site Number : 3800004 — Siena
Singapore · 2 centers
- Investigational Site Number : 7020002 — Singapore
- Investigational Site Number : 7020001 — Singapore
Sweden · 2 centers
- Investigational Site Number : 7520002 — Gothenburg
- Investigational Site Number : 7520003 — Lund
Taiwan · 2 centers
- Investigational Site Number : 1580001 — Kaohsiung City
- Investigational Site Number : 1580002 — Taipei
Canada · 1 center
- Investigational Site Number : 1240002 — London
Saudi Arabia · 1 center
- Investigational Site Number : 6820003 — Riyadh
Identifiers
NCT: NCT07053423 · LPS18583 · 2025-521268-37 · U1111-1314-5262