VESTIGE-dupilumab and lung function in Asthma
Research type
Research Study
Full title
Randomized, double blind, placebo controlled study to evaluate the effect of dupilumab on airway inflammation through assessments of lung function, mucus plugging and other lung imaging parameters in patients with asthma
IRAS ID
280970
Contact name
Kieran Maher
Contact email
Sponsor organisation
Sanofi-Aventis Groupe
Eudract number
2019-004647-74
Duration of Study in the UK
1 years, 7 months, 2 days
Research summary
Chronic airway inflammation is a characteristic feature of asthma and is associated with mucus production, airway smooth muscle contraction and hypertrophy, airway hyperresponsiveness and structural airway remodelling. The underlying cause of airway remodelling in asthma remains to be fully understood.
Dupilumab has the potential to exert an unplugging effect on the airways by reducing mucus
production, due to the anti-inflammatory effect via direct inhibition of IL-13 signalling.
The goal of this study is to gain further insight into the effect of dupilumab on lung function and
also explore the effect on airway changes, biomarkers to and gain preliminary understanding of the
potential interrelationships between these parameters.
This is a 24-week double-blind placebo-controlled study, designed to assess the effect of dupilumab on airway inflammation through assessments of lung function, mucus plugging and other lung imaging parameters in patients with asthma.
Study participation for each patient will be between 29 and 41 weeks. The study includes: a screening period of approx. 4 weeks from signed informed consent to first treatment, a randomised, placebo-controlled treatment period of 24 weeks from baseline and a post treatment follow-up period (up to 12 weeks). Patients who fulfil the inclusion criteria and do not meet any of the exclusion criteria will be randomized (2:1) to one of the following investigational medicinal products (IMP)
Dupilumab: patients will receive a loading dose of 600 mg of dupilumab (2 x 300 mg dupilumab subcutaneous (SC) on Day 1, followed by 300 mg every 2 weeks for 24 weeks.
Placebo: patients will receive 2 x 2 mL placebo injections SC on Day 1, then 1 placebo injection every 2 weeks for 24 weeks.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
20/EM/0162
Date of REC Opinion
27 Oct 2020
REC opinion
Further Information Favourable Opinion