GLPG1690 with Standard Treatment in Idopathic Pulmonary Fibrosis
Research type
Research Study
Full title
A Phase 3, randomized, double-blind, parallel-group, placebo controlled multicenter study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis.
IRAS ID
254823
Contact name
Niyati Prasad
Contact email
Sponsor organisation
Galapogas NV
Eudract number
2018-001405-87
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 31 days
Research summary
Research Summary
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, severely debilitating, ultimately lethal lung disease predominantly affecting elderly male smokers or ex-smokers. The disease is characterised by progressive worsening of breathing problems and lung function and is associated with average survival time of 2-5 years following diagnosis. Current treatments merely slow down the decline 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.Patients with IPF have increased levels of substances called “autotaxin” and “lysophosphatidic acid (LPA)” in their lungs. Autotaxin is an enzyme responsible for the production of LPA. GLPG1690 is a novel, potent and selective small-molecule inhibitor of autotaxin which could slow the progression of IPF by decreasing autotaxin and LPA levels in the lungs. A previous study has shown GLPG1690 to be safe and well tolerated and that disease remained stable during the treatment period.
The current phase 3, randomised, placebo-controlled trial, sponsored by Galapagos NV, is the next step in the development of GLPG1690 and will evaluate the efficacy and safety of two doses of oral GLPG1690 compared to placebo in patients with IPF in addition to local standard of care.
This trial will involve 750 patients worldwide. Male and female patients over the age of 40 with confirmed diagnosis of IPF are eligible to take part. Participants randomised to the study will have at least 12 out-patient hospital visits for study assessments in the first 12 months, then every 12 weeks thereafter. Study assessments will include pulmonary function tests, questionnaires, physical exams and blood tests to help monitor the health and well-being of study participants and assess the effectiveness and safety of GLPG1690. Participants will stay in the study until the last participant has completed 52 weeks treatment.
Summary of Results
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
19/SC/0034
Date of REC Opinion
29 Mar 2019
REC opinion
Further Information Favourable Opinion