GLPG1690-CL-303 sub-study with xenon magnetic resonance imaging
Research type
Research Study
Full title
An exploratory sub-study to protocol GLPG1690-CL-303 to assess lung function in patients with idiopathic pulmonary fibrosis, using hyperpolarized xenon magnetic resonance imaging
IRAS ID
269743
Contact name
Jim Wild
Contact email
Sponsor organisation
Galapagos NV
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, severely debilitating, ultimately lethal lung disease mainly affecting elderly male smokers or ex-smokers. Current treatments merely slow down the reduction in lung function but the remaining decline over 1 year remains substantial. There is an urgent need for therapies can which halt or slow this decline further. Study protocol GLPG1690-CL-303, sponsored by Galapagos NV, is looking at the safety and efficacy of two doses of oral GLPG1690 compared to placebo in addition to local standard of care in patients with IPF.
This study is an optional sub-study to the GLPG1690-CL-303 protocol. This sub study will assess the merits of the Xenon Magnetic Resonance Imaging (129Xe-MRI) method to determine changes in lung function compared to other standard methods of measurement. This method may enable faster detection of disease progression in smaller numbers of patients and may also be able to show a dose relationship between the two doses of GLPG1690 used in the GLPG1690-CL-303 study.
25 participants in the United Kingdom who are eligible to participate in GLPG1690-CL-303 will be recruited to take part in this-sub study. If participants fail screening for the main study they will not be able to participate in this sub-study.
This sub-study will take place at the at the University of Sheffield, at either Royal Hallamshire Hospital or Northern General Hospital in Sheffield (Sheffield Teaching Hospitals). The current sub-study protocol includes MRI scans, CT scan and spirometry. No additional treatment will be provided apart from the investigational medicinal product covered by the GLPG1690-CL-303 protocol.
REC name
Wales REC 5
REC reference
19/WA/0277
Date of REC Opinion
30 Oct 2019
REC opinion
Further Information Favourable Opinion