LUCENT-3 Extension Study of Mirikizumab in Ulcerative Colitis
Research type
Research Study
Full title
A Phase 3, Multicenter, Long-term, Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis.
IRAS ID
243666
Contact name
Carly Anderson
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2017-004092-31
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 3 days
Research summary
Ulcerative Colitis (UC) is a condition that causes inflammation and ulceration of the rectum and colon. Ulcers develop on the surface of the lining and these may bleed and produce mucus. UC has a relapsing–remitting course, meaning that patients have intermittent disease flares that are interspersed with symptom free periods.
There is no cure for UC, but medication, and sometimes surgery, can give long periods of relief from symptoms. The cause of UC is not known, but higher levels of a protein called Interleukin-23 (IL-23) have been found in the intestine of patients with UC. IL-23 is a protein secreted by white blood cells and cells in your tissues that stimulates inflammation. Inflammation is a key part of the body’s immune system (the body’s natural defence), but in patients with UC, this pathway is over stimulated. Mirikizumab is a monoclonal antibody that binds to IL-23, helping to control this excessive inflammation.
The purpose of this AMAP study is to determine how safe and effective mirikizumab is in controlling UC in the long term. It is an outpatient study that will involve approximately 600 to 830 patients from around the world, who have previously had moderately to severely active UC and have participated in a previous mirikizumab UC study. Some of these patients will only have been receiving placebo (a substance that looks like the study medication but has no medicine/no therapeutic effect). In AMAP, all patients will receive mirikizumab subcutaneously every 4 weeks for up to 3 years, or until mirikizumab is commercially available in the country in which the patient resides, whichever occurs first. All patients may remain in AMAP as long as mirikizumab is tolerated with no safety concerns and, in the opinion of their study doctor, the person is benefitting from the study drug.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
18/SC/0315
Date of REC Opinion
25 Jun 2018
REC opinion
Favourable Opinion