VIB4920.P2.S2, Ph2, Pts with Sjögren's Syndrome, VIB4920
Research type
Research Study
Full title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in subjects with Sjogren's Syndrome (SS)
IRAS ID
272352
Contact name
Lisa Pitt
Contact email
Sponsor organisation
Viela Bio, Inc.
Eudract number
2019-002713-19
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
128905, IND number
Duration of Study in the UK
1 years, 10 months, 3 days
Research summary
This is a randomised, double-blind, placebo-controlled, parallel-arm study to test a new investigational medicine VIB4920. The main purpose of this study is to determine how well VIB4920 is tolerated in patients with Sjögren’s Syndrome (SS), to determine if it causes any side effects, and to learn if it can improve the signs and symptoms of SS. SS is an autoimmune disease (when the body’s immune system attacks itself) causing inflammation of the glands in the mouth and eyes leading to loss of function and excessive dryness (glandular). It also manifests in the joints, lungs, skin, and gastrointestinal tract (extraglandular).
There's currently no cure for SS. People with SS, suffer dryness in their skin, mouth and eyes, muscle and joint pain, and fatigue which can be debilitating and have a negative impact on quality of life. It can create emotional challenges; impair social life with dependency on relatives in daily life and difficulties at work and other tasks.
VIB4920 is a man-made protein with potential therapeutic activity in a number of autoimmune diseases such as SS, designed to target the immune system cells responsible for these attacks. VIB4920 will be compared with the placebo, saline(salt water) that contains no active medicine. Researchers use a placebo to see if a research medicine works better or is as safe as not taking anything at all. Patients who will be eligible for the study are those who have been diagnosed with SS. Patients will visit the site 15 times and the study will last 56 weeks. This includes the screening period (4 weeks) to evaluate if the patient can participate in the study, the treatment period (40 weeks) and the follow up period (12 weeks) after the last treatment. Approximately 174 patients are expected to participate in this study at 50 research sites globally.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0361
Date of REC Opinion
15 Jan 2020
REC opinion
Further Information Favourable Opinion