The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma
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
Outcome
Mixed primary results
registry NUMBER Dupilumab 300 mg Q2W: 56.9 percentage of participants NCT04400318 ↗
registry NUMBER Placebo: 10.8 percentage of participants NCT04400318 ↗
registry analysis (superiority test); Dupilumab 300 mg Q2W vs Placebo; p <0.001; Odds Ratio (OR) 9.81 (95% CI 3.13 to 30.82); Cochran-Mantel-Haenszel NCT04400318 ↗
registry LEAST_SQUARES_MEAN Dupilumab 300 mg Q2W: 19.73 (Standard Error 8.102) percent change NCT04400318 ↗
registry LEAST_SQUARES_MEAN Placebo: -2.04 (Standard Error 11.538) percent change NCT04400318 ↗
registry analysis (superiority test); Dupilumab 300 mg Q2W vs Placebo; p = 0.138; Least square mean difference 21.76 (95% CI -7.73 to 51.25); MMRM NCT04400318 ↗
Publications
- Porsbjerg C, Dunican EM, Lugogo NL, Castro M, Papi A, Backer V, Brightling CE, Bourdin A, Virchow JC, Zhang M, Soler X, Rowe PJ, Deniz Y, de Prado Gomez L, Sacks HJ, Jacob-Nara JA. Effect of dupilumab on mucus burden in patients with moderate-to-severe asthma: the VESTIGE trial. Am J Respir Crit Care Med. 2026 Feb 1;212(2):241-252. doi: 10.1164/rccm.202410-1894OC.
- Castro M, Papi A, Porsbjerg C, Lugogo NL, Brightling CE, Gonzalez-Barcala FJ, Bourdin A, Ostrovskyy M, Staevska M, Chou PC, Duca L, Pereira AM, Fogarty C, Nadama R, Zhang M, Rodrigues A, Soler X, Sacks HJ, Deniz Y, Rowe PJ, de Prado Gomez L, Jacob-Nara JA. Effect of dupilumab on exhaled nitric oxide, mucus plugs, and functional respiratory imaging in patients with type 2 asthma (VESTIGE): a randomised, double-blind, placebo-controlled, phase 4 trial. Lancet Respir Med. 2025 Mar;13(3):208-220. doi: 10.1016/S2213-2600(24)00362-X. Epub 2025 Feb 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dupilumab | Monoclonal antibody | 300 mg | Subcutaneous |