Safety, blood levels and effects of GLPG1690 in subjects with IPF
Research type
Research Study
Full title
Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects with Idiopathic Pulmonary Fibrosis (IPF)
IRAS ID
193530
Contact name
Toby Maher
Contact email
Sponsor organisation
Galapagos NV
Eudract number
2015-004157-41
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, severely debilitating, and ultimately lethal lung disease predominantly affecting elderly male smokers or ex-smokers with a median age of 65-70 years. The disease is characterized by progressive worsening of dyspnoea and lung function, and is associated with a poor prognosis.
The current two treatments (pirfenidone and nintedanib) are currently approved in the EU and US. These treatments appear to slow disease progression but are frequently associated with side effects potentially limiting the use in
clinical practice. There thus remains a significant unmet medical need for the investigation and development of novel IPF treatments targeting disease-relevant pathways.Galapagos is currently pursuing the development of GLPG1690, a small-molecule autotaxin (ATX) inhibitor targeting disease-relevant signal transduction pathways, for the treatment of IPF. GLPG1690 is the first ATX inhibitor in clinical development for the oral treatment of IPF.
Approximately 24 participants will take part in the study in France, Italy, UK and Ukraine.
Participants will take part in the study for 12 weeks and shall attend 8 visits to the study centre. The study is divided into three periods: screening, treatment, and follow up.
In order to see if it works, the study drug will be compared to a “placebo” (substance looking identical to GLPG1690, but not containing the active drug). This will also be given once a day for 12 weeks.
Study procedures include (but are not limited to) physical examinations, ECGs, lung function tests, blood tests, bronchoscopy, high resolution computed tomography (HRCT) and questionnaires.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
15/EM/0555
Date of REC Opinion
24 Dec 2015
REC opinion
Unfavourable Opinion