I6T-MC-AMAG study of LY3074828 in Active Crohns Disease (SERENITY)
Research type
Research Study
Full title
A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY)
IRAS ID
214920
Contact name
Jonathan MacDonald
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2016-002204-84
Duration of Study in the UK
3 years, 10 months, 10 days
Research summary
Research Summary
This study is a Phase 2 study designed to determine whether the study drug LY3074828, (a humanised monoclonal antibody), is safe and effective in subjects with moderate to severe Crohn’s disease. Despite an influx of new biological therapies, many subjects with Crohn’s disease experience primary or secondary treatment failure; ; Interleukin -23 (IL-23)is a substance that is produced by white blood cells to fight against infections and diseases and is a validated target for evaluation of treatment of various autoimmune/inflammatory diseases, including Crohn’s disease. This Phase 2 study will help evaluate safety and determine the clinical activity defined by improvement in Crohn’s disease activity measures and key patient-reported outcomes (PRO) measures. \nCrohn’s disease is a type of inflammatory bowel disease (IBD) that may affect any part of the gastrointestinal tract from mouth to anus. Crohn’s disease is caused by a combination of environmental, immune and bacterial factors in genetically susceptible individuals. It results in a chronic inflammatory disorder, in which the body’s immune system attacks the gastrointestinal tract possibly directed at microbial antigens. While Crohn’s is an immune related disease, it does not appear to be an autoimmune disease (in that the immune system is not being triggered by the body itself). LY3074828 is being developed for the treatment of autoimmune diseases where the IL-23 pathway is thought to have a significant pathogenic (able to cause disease) role. This study is a multicentre, randomised, parallel-arm, placebo-controlled trial in which approximately 180 subjects will be randomised with a 2:1:1:2 allocation across the 4 treatment arms (1000, 600, 200 mg LY3074828, and placebo)
Summary of Results
Participants receiving mirikizumab were found to have greater improvement thatn participants receiving placebo after 12 weeks on treatment, as measured by endoscopic evaluation (endoscopic response rate defined as at least 50% reduction from baseline in the Simple Endoscopic Score for Chron's Disease). Participants receiving miikizumab had similar frequencies of adverse events compared with participants receiving placebo.
REC name
West of Scotland REC 1
REC reference
16/WS/0245
Date of REC Opinion
1 Feb 2017
REC opinion
Further Information Favourable Opinion