* Efficacy, safety and tolerability of LYS006 in mild to moderate UC
Research type
Research Study
Full title
A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis
IRAS ID
304074
Contact name
Claus-Peter Danzer
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2019-003113-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 18 days
Research summary
The purpose of the study is to evaluate the safety and effect of a treatment called LYS006 in treating mild to moderate ulcerative colitis. Patients who have been diagnosed with ulcerative colitis for at least 3 months, who are aged 18-75 years will be eligible to take part. Participation in the study will last for about 4 months.
Patients will be allocated by chance to receive LYS006 or placebo. A placebo contains no active treatment and is often referred to as a “dummy treatment”; it is used to make sure that the reported changes are not happening by chance. Two thirds of participants will receive LYS006 and one third will receive placebo. Neither the patients nor their doctor will know which treatment they are getting.
Patients participating in the study will visit the hospital 7 or 8 times, where they will have assessments and be asked questions related to their disease, such as how they are feeling, if they have rectal bleeding, and how often they are going to the bathroom. There will be a number of tests and analyses done in order to understand how LYS006 affects the body, if it improves mild to moderate ulcerative colitis, and if it is safe. There will also be tests done to understand how LYS006 affects disease activity in the body.
45 patients will take part in the study in 10 countries. In the UK, there will be one site in Glasgow. The study is organised and funded by a company named Novartis.
REC name
North West - Haydock Research Ethics Committee
REC reference
22/NW/0251
Date of REC Opinion
21 Sep 2021
REC opinion
Favourable Opinion