NOVESA - GLPG1690-CL-204:Phase 2a study in pts with systemic sclerosis
Research type
Research Study
Full title
A Phase 2a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, and tolerability of orally administered GLPG1690 for 24 weeks in subjects with systemic sclerosis
IRAS ID
253572
Contact name
Prof Christopher Denton
Contact email
Sponsor organisation
Galapagos NV
Eudract number
2018-001817-33
Duration of Study in the UK
1 years, 3 months, 27 days
Research summary
Scleroderma is a rare condition caused by the immune system attacking the connective tissue which can be life threatening. The disease is more common in women than men. Within the systemic forms of scleroderma, there are three major categories of the disease: (i) fibrosis with thickening of the skin and inner organs, (ii) inflammation, and (iii) vasculopathy. Major organs affected are the skin, lungs, digestive system, kidneys, muscles, and the heart. \n\nAt present, there are no approved drugs for the treatment of systemic sclerosis and there is significant unmet need for effective treatment options for this disease.\n\nThis is a randomised, double-blind, parallel-group, placebo-controlled, multi-center,\nPhase 2a study designed to evaluate the efficacy, safety, and tolerability of GLPG1690 administered over 24 weeks in adult subjects with a confirmed diagnosis of systemic sclerosis. \n\nPatients will be randomised in a 2:1 ratio: two thirds will receive GLPG1690 once daily and one third matching placebo once daily. A total of approximately 30 patients will be randomised with 4 expected from the UK.\n\nStudy procedures include physical examination, vital signs, ECG, blood sampling, lung function tests, HRCT scans and various assessments. \n\nThis study is sponsored by Galapagos. \n
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
18/EE/0399
Date of REC Opinion
14 Jan 2019
REC opinion
Further Information Favourable Opinion