LOUiSSe - study of LOU064 in patients with Sjögrens syndrome
Research type
Research Study
Full title
An adaptive, Phase 2 randomised double-blind, placebo-controlled multi-centre study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjögrens syndrome (LOUiSSe)
IRAS ID
261307
Contact name
Wan Fai Ng
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-004387-54
Duration of Study in the UK
2 years, 11 months, 19 days
Research summary
Summary of Research
This study with LOU064 is an adaptive phase 2 study designed to establish safety and efficacy and characterize the dose-response of LOU064 in patients with moderate to severe Sjogren's Syndrome to allow further development of the compound for treatment of this disease. Female and male patients aged 18 to 75 years with moderate to severe SjS; a total of approximately 252 patients will be enrolled globally, with 5 sites in the UK and a target of 5 patients recruited in the UK.
The study consists of two parts. In Part I, the highest expected active dose is being tested in two different regimens; once daily or twice daily, with a placebo arm as a comparator.
In Part 2, the dosing regimen chosen will be expanded to lower doses to test the safety and response between the lowest and highest doses of LOU064.Summary of Research
A lay summary of results will be published by 22-Nov-2022 at novctrd.com and can be found by searching by Medical Condition Sjoegren's syndrome, followed by Product Code LOU064.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0571
Date of REC Opinion
2 Dec 2019
REC opinion
Further Information Favourable Opinion