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NCT07053423 · ClinicalTrials.gov registry record · Phase 4
A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
A Phase 4 study of Chronic Obstructive Pulmonary Disease, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 218
- Enrollment target
- 20
- Study locations
NCT07053423: Recruiting Phase 4 study of Chronic Obstructive Pulmonary Disease, sponsored by Sanofi.
NCT07053423 is a Phase 4 study of Chronic Obstructive Pulmonary Disease that is actively recruiting participants, run by Sanofi. The registered enrollment target is 218 participants, below the 1,751-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07053423, a Phase 4 study of Chronic Obstructive Pulmonary Disease, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 218 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dupilumab
Study Locations (20)
Other
- Investigational Site Number : 0320002 - Buenos Aires
- Investigational Site Number : 0320003 - Buenos Aires
- Incor - Instituto do Coracao- Site Number : 0760001 - São Paulo
- Investigational Site Number : 1560001 - Guangzhou
- Investigational Site Number : 2080003 - Aalborg
- Investigational Site Number : 2080002 - Vejle
- 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
Alabama
- University of Alabama at Birmingham - School of Medicine- Site Number : 8400003 - Birmingham
Florida
- Finlay Medical Research- Site Number : 8400010 - Miami
North Carolina
- American Health Research - Charlotte- Site Number : 8400013 - Charlotte
Pennsylvania
- Clinical Research Associates of Central PA- Site Number : 8400002 - DuBois
Texas
- REX Clinical Trials - Beaumont- Site Number : 8400011 - Beaumont
Tucumán Province
- Investigational Site Number : 0320001 - San Miguel de Tucumán
Rio Grande do Sul
- Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760002 - Porto Alegre
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2025-09-22 |
| Est. Completion | 2029-02-15 |
| Phase | Phase 4 |
What NCT07053423 shows while recruiting
NCT07053423 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, below the 1,751-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07053423 names 20 study sites across 8 states, led by Other, Alabama, Florida.
Frequently Asked Questions
What is clinical trial NCT07053423 about?
NCT07053423 is a clinical study titled "A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.". 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 a...
What is the current status of trial NCT07053423?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 218 participants. The study started on 2025-09-22. Estimated completion is 2029-02-15.
What conditions does trial NCT07053423 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease.
What interventions are being tested in trial NCT07053423?
The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG).
Who is sponsoring clinical trial NCT07053423?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07053423 being conducted?
This trial has 20 study locations across Alabama, Florida, North Carolina, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Obstructive Pulmonary Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07053423's enrollment target sits among peer trials
218 37th of 86 higher than 50 of 86 other Chronic Obstructive Pulmonary Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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