RO5459072 in Primary Sjogren's Syndrome
Research type
Research Study
Full title
A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO5459072 IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME
IRAS ID
202991
Contact name
Benjamin Fisher
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2015-004476-30
Duration of Study in the UK
0 years, 5 months, 9 days
Research summary
Sjögren’s syndrome is a chronic systemic autoimmune disease in which an inappropriate immune response to self-antigens (certain molecules in the body) causes secretory gland dysfunction and systemic symptoms. It is characterised by lymphocyte (a type of immune cell) infiltration of the lacrimal glands (which produce tears) and salivary glands as well as the presence of circulating autoantibodies (antibodies that target the body’s own tissue).
There is no approved, effective treatment for Sjögren’s syndrome with the exception of products used for managing symptoms of the disorder.
Whilst the exact causes of Sjögren’s syndrome are currently unknown, data suggests the importance of a process called ‘MHC-II antigen presentation’ in the disease. Cathepsin S is an enzyme in the body that is involved in the ‘MHC-II antigen presentation’ and medications that inhibit Cathepsin S have been shown to be effective in non-clinical studies of auto-immune disorders including Sjögren’s syndrome. This is the first clinical study to test the effects of a Cathepsin S inhibitor medication (RO5459072) in participants with Sjögren’s syndrome.
This study is therefore being conducted with the principal aim of investigating the effects of RO5459072 treatment on disease activity and symptoms of Sjögren’s syndrome. It will also investigate the pharmacological effects of RO5459072 and the effects of RO5459072 on the immune system.
This study aims to recruit 70 participants with primary Sjögren’s syndrome. Participants will be randomly selected to receive either study medication RO5459072 or placebo in a 1:1 ratio. Approximately 30 participants will be enrolled into an optional sub-study, with the purpose of looking at the effects of treatment with RO5459072 on the salivary glands and inflammation. The study will last approximately 18 weeks in total and participants will receive treatment for 12 weeks. The study will be performed at sites in the USA and Europe.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0197
Date of REC Opinion
22 Jun 2016
REC opinion
Further Information Favourable Opinion