drugset / Trial / NCT04400318

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

NCT04400318

Phase 4 Completed 109 enrolled Sanofi Regeneron Pharmaceuticals · collab
RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start
2020-06-20
Primary completion
2023-06-26
Completion
2023-08-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Dupilumab Monoclonal antibody 300 mg Subcutaneous

Indications