CLUES-UC (b)
Research type
Research Study
Full title
Casting Light on Urgency and Effectiveness of an Advanced Therapy in ulcerative Colitis (CLUES-UC): An Observational Study of Mirikizumab in Adults with Moderately to Severely Active Ulcerative Colitis.
IRAS ID
354329
Contact name
Shaji Sebastian
Contact email
Sponsor organisation
Eli Lilly and Company
Duration of Study in the UK
4 years, 6 months, 1 days
Research summary
This study is a prospective, descriptive, single-arm observational study of approximately 300 adult participants with moderately to severely active Ulcerative Colitis initiating mirikizumab.
This study is being sponsored by Eli Lilly and Company and will be run in multiple countries, including the United States, United Kingdom and several European countries.
Patients will be followed-up for up to 2 years. Data will be collected from their routine visits at baseline, Weeks 12, 24, 36, 52, 64, 76, 88, and 104, including PROs.
Mirikizumab has recently been granted marketing authorization in Canada, Europe, Japan, the United States, and the United Kingdom, joining a broad landscape of treatments for moderately to severely active ulcerative colitis. The main information we are interested in is to describe the 1-year symptomatic remission with initiation of mirikizumab in participants with moderately to severely active UC. The findings from this observational study will help demonstrate the innovative value of Mirikizumab for routine clinical care.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
25/YH/0096
Date of REC Opinion
14 Jul 2025
REC opinion
Further Information Favourable Opinion