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NCT04400318 · ClinicalTrials.gov registry record · Phase 4

The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma

A Phase 4 study, sponsored by Sanofi.

Completed
Registry status
Phase 4
Development phase
109
Enrollment target

NCT04400318 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 109 participants.

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The verdict

NCT04400318, a Phase 4 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 4
Development phase
109 participants
Enrollment target

Study Summary

Primary Objective: • To assess the effect of dupilumab on lung inflammation and related changes in airway volumes detectable by functional respiratory imaging Secondary Objective: * To evaluate the effect of dupilumab at Week 24 on bronchodynamics, hyperinflation, airway resistance, airway wall thickness, ventilation defects and mucus plugging derived from high-resolution computed tomography (HRCT) scans, patient-reported outcomes, FeNO and spirometry. * To evaluate safety of dupilumab

Interventions

  • DRUG Placebo
  • DRUG Dupilumab

Trial Details

FieldValue
Enrollment Target 109 participants
Start Date 2020-06-20
Est. Completion 2023-08-21
Phase Phase 4

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT04400318

The ClinicalTrials.gov registry entry for NCT04400318 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04400318 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04400318 about?

NCT04400318 is a clinical study titled "The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma". Primary Objective: • To assess the effect of dupilumab on lung inflammation and related changes in airway volumes detectable by functional respiratory imaging Secondary Objective: * To evaluate the effect of dupilumab at Week 24 on bronchodynamics, hyperinflation, airway resistance, airway wall t...

What is the current status of trial NCT04400318?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 109 participants. The study started on 2020-06-20. Estimated completion is 2023-08-21.

What interventions are being tested in trial NCT04400318?

The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG).

Who is sponsoring clinical trial NCT04400318?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.