GLPG1690-CL-206 - OLE study in patients with systemic sclerosis
Research type
Research Study
Full title
A multicenter, open-label extension study to evaluate the long-term safety, tolerability and efficacy of orally administered GLPG1690 in subjects with systemic sclerosis
IRAS ID
264959
Contact name
Prof Christopher Denton
Contact email
Sponsor organisation
Galapagos NV
Eudract number
2019-001279-34
Duration of Study in the UK
2 years, 2 months, 18 days
Research summary
Research Summary:
This is an open-label extension study to evaluate the long-term safety, tolerability and efficacy of orally administered GLPG1690 in patients with systemic sclerosis.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.
At 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.
An extension study will allow the continued treatment of patients who have completed the parent study GLPG1690-CL-204 and will be eligible to participate in the extension study.
Study procedures include physical examination, vital signs, ECG, blood sampling, lung function tests and various assessments.
This study is sponsored by Galapagos NV.
Summary of Results:
No lay study results summary will be created for this trial. But study results will be posted on both EudraCT & CT.gov before the required deadline (1 year after study completion)REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0309
Date of REC Opinion
20 Aug 2019
REC opinion
Further Information Favourable Opinion