Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Dupilumab for Chronic Obstructive Pulmonary Disease

LPS18583 is a multinational, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group, Phase 4 study with 2 treatment groups. this study wants to assess the effect of dupilumab compared with dummy treatment (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).

Official registry: https://clinicaltrials.gov/study/NCT07053423 · Sanofi · enrollment listed as 218

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Dupilumab, or Placebo. The registry lists allocation as randomized. LPS18583 is a multinational, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group, Phase 4 study with 2 treatment groups.

They plan to enroll about 218 people at 85 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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.

Interventions: Dupilumab, Placebo

Primary outcome (registry wording): Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring)

Who it is for (from inclusion criteria)

  • Ages 40 Years to 85 Years
  • 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)

Public study contact (from the registry)

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

800-633-1610

contact-us@sanofi.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

85 listed

+ 74 sites outside the US on the same record

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseLumezzane, Brescia
Not a traditional drug phase: Maximal strenght training (MST) plus endurance training (ET) for Chronic Obstructive Pulmonary Disease

In the context of pulmonary rehabilitation of COPD patients, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of side effects. Maximal Strength Training (MST) is a kind of RT typically performed at \~85-90% of 1RM with maximal velocity to be developed in the concentric phase.

NCT03799354 · Official ClinicalTrials.gov record · Istituti Clinici Scientifici Maugeri SpA

RecruitingNot a traditional drug phaseClermont-Ferrand
Not a traditional drug phase: Development of a screening algorithm designed to determine a "dysmobility" profile in patients with chronic illness. for Joint Osteoarthritis

Chronic illness is a public health issue and mobility loss is frequent in this population. Among its' multiple physical and psychological consequences, increased mortality and cardiovascular morbidity seem the main concern.

NCT04375280 · Official ClinicalTrials.gov record · University Hospital, Clermont-Ferrand

FAQ about this NCT record

Is NCT07053423 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07053423?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07053423?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary