UCB5857 For Participants with Primary Sjogren's Syndrome
Research type
Research Study
Full title
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJӦGREN’S SYNDROME
IRAS ID
177344
Contact name
Simon Bowman
Contact email
Sponsor organisation
UCB Celltech, UK
Eudract number
2014-004523-51
Duration of Study in the UK
1 years, 6 months, 16 days
Research summary
Primary Sjӧgren’s Syndrome (pSS) is an autoimmune condition, which means that instead of protecting the body from infection or illness, the immune system reacts abnormally and start attacking healthy cells and tissue. In pSS, secretory glands are attacked and become inflamed, reducing their ability to produce moistening fluids. Women are more likely to be affected by pSS than men. Owing to the reduced function of these glands, the symptoms of pSS include dry eyes, dry mouth and for women, vaginal dryness. This Phase 2 study will evaluate how safe and effective a new experimental medication called UCB5857 is for treating individuals suffering from primary Sjӧgren’s Syndrome (pSS). This study will compare the effect of UCB5857 on relieving the symptoms of pSS sufferers to a matching placebo a capsule that looks identical to the study medication but has no medicinal affect. Neither the participant nor the investigators at the study site will know which treatment (UCB5857 or placebo) each participant has taken. In addition, participants taking part in this study will continue to take their current treatments whilst also taking the study medication (UCB5857 or placebo). Around 85 male and female patient aged 1875 will be enrolled across approximately 17 sites throughout Europe. The study will require 6 visits to the study site and take around 18 weeks to complete for each participant. The study comprises of a screening period, a 12week treatment period where the participant will either receive the study medication UCB5857 or a matching placebo, and an end of trial safety follow up phase.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0139
Date of REC Opinion
15 May 2015
REC opinion
Further Information Favourable Opinion