Filgotinib, GS-9876, GS-4059 in Adults with Active Sjogren’s Syndrome
Research type
Research Study
Full title
A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib, GS-9876 and GS-4059 in Adult Subjects with Active Sjogren’s Syndrome
IRAS ID
223457
Contact name
Elizabeth Price
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2016-003558-34
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
123903, IND Number
Duration of Study in the UK
1 years, 10 months, 31 days
Research summary
Sjogren’s Syndrome (SjS) is a disease where a person’s own immune system attacks parts of the body such as the joints, the skin and the glands that make tears for the eyes or saliva for the mouth. It is estimated to affect approximately 1% of the population worldwide. Therapeutic options for Sjogren’s syndrome are few. There is an unmet need for safe therapies that can effectively improve the disease course.
This is a randomised, double-blind, placebo-controlled study sponsored by Gilead Sciences, Inc. The purpose of this study is to see how safe and effective filgotinib, GS-9876 and GS-4059 are at treating Sjogren’s Syndrome.
Approximately 140 participants (male and female) from 70 study centres in 8 countries, in North America and Europe will take part. Participation will last about 52 weeks, not including the screening visit. During this time, participants will be required to visit the clinic at least 14 times.
Participants will be randomly assigned (like tossing a coin) to the medicine. They will have 1 out of 4 chance (25%) to receive filgotinib, 1 out of 4 chance (25%) to receive GS-9876, 1 out of 4 chance (25%) to receive GS-4059, and 1 out of 4 chance (25%) to receive placebo (dummy drug).
Study procedures include: Review your health history and Sjogren’s Syndrome history, Complete physical examination (including weight and height), physical exam, vital signs (blood pressure, heart rate, breathing rate, body temperature), blood, urine and saliva samples, examinations, ECG (recording or the heart), breathing tests, dry mouth test, eye exams, ultrasound, CT scan, administration of study medicine.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
17/LO/0825
Date of REC Opinion
28 Jun 2017
REC opinion
Further Information Favourable Opinion