I6T-MC-AMAN, Ulcerative Colitis (LUCENT 1)
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis - LUCENT 1
IRAS ID
244505
Contact name
Jimmy Limdi
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2017-003229-14
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 11 months, 22 days
Research summary
This study has been designed to find out if the study medication Mirikizumab (LY3074828) alone, when compared with other standard treatments already used, is an effective treatment for patients with moderate to severe ulcerative colitis (UC). UC is a chronic, or ongoing, inflammatory bowel disease (IBD) that primarily affects the large intestine. The exact causes of UC are unknown and the current treatments are not effective for all patients or only provided limited relief.
IL-23 (Interleukin-23) is a pro-inflammatory cytokine or more simply an inflammatory cytokine is a type of signalling molecule that is excreted from immune cells and certain other cell types that promote inflammation. IL-23 expression is enhanced in the intestine of patients with active UC. Mirikizumab is designed to bind to IL-23 and neutralise its activity.
This study is taking place internationally and there will be about 1160 patients all around the world who will be taking part, including approximately 56 in the UK. It will take about 4 years to complete the whole study but individual participation in the study is expected to last up to 32 weeks. Participants who successfully complete the 12-week induction period will have the opportunity to take part in the follow-on Maintenance Study, LUCENT 2. The study consists of a 28-day Screening period, a 12-week Treatment (Induction) period and, for participants who do not join LUCENT 2, a 16-week Follow-Up period.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0517
Date of REC Opinion
24 Oct 2018
REC opinion
Further Information Favourable Opinion