* INSTRUCT-UC: LY3471851 in Adults with Ulcerative Colitis (UC)
Research type
Research Study
Full title
An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis
IRAS ID
292787
Contact name
Syed Samiul Hoque
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2020-003017-35
Duration of Study in the UK
3 years, 4 months, 0 days
Research summary
Ulcerative Colitis (UC) is a form of Inflammatory Bowel Disease, a group of conditions that cause swelling and irritation in the digestive tract. Depending on the severity and location of the inflammation, the symptoms of UC can range from mild to severe and may include diarrhea, abdominal pain and cramping or fever. Over time, the effects of UC can spread beyond the digestive tract, creating complications throughout the body.
UC is brought on by a combination of factors, including genetics, environment and an abnormal reaction of the immune system to certain bacteria in the gut. Current drugs for UC can lengthen the time between flare-ups and make them less severe. UC is currently an incurable condition that calls for research into treatments bringing dependable, longer-lasting relief or cure.
The study drug LY3471851 is proposed to restore normal self-tolerance mechanisms required to manage UC. The reason for INSTRUCT-UC study is to determine if this new treatment plan is safe and effective in adults with moderately to severely active UC who have intolerance, insufficient or no response to other UC therapies. 200 patients globally, with at least 8 in the UK, will receive LY3471851 or placebo as subcutaneous single injection (under the skin) every 2 weeks for 52-weeks. Neither the participant nor the study doctor will know which treatment group the patients are in to avoid bias and understand the effects of LY3471851. In stage 1 of the study, two doses (high and low) of LY3471851 will be compared to placebo. In stage 2, one or more new doses of LY3471851 may be added based on results from stage 1. Participants that do not respond to assigned treatment at week 12 will have a chance to receive high dose of LY3471851. Overall participation may last up to 63 weeks.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
22/NE/0149
Date of REC Opinion
1 Feb 2021
REC opinion
Further Information Favourable Opinion