Title: An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
Associated condition: Ulcerative colitis
Status: Currently enrolling
Brief summary: This is a prospective, observational multi-site study without randomization.
This is a double-blind placebo controlled randomized Phase 3/4 study in subjects with nonalcoholic steatohepatitis (NASH) and fibrosis stages 2-3 who are overweight or obese and have prediabetes or type 2 diabetes. Subjects will be randomized to receive Aramchol 300mg BID or matching placebo in a 2:1 randomization ratio.
Primary objectives: to evaluate the performance characteristics of a blood-based ctDNA LUNAR-2 test to detect colorectal cancer in a screen-relevant, average risk population.
Estimated length of study: Maximum of 5 years from last subject’s randomization, with an estimate that the study to be fully completed in December 2024.
For more detailed information on this research trial, including eligibility and study design, please visit the clinical trial page at U.S. National Library of Medicine’s website. Note you can submit your information for consideration by submitting the contact form on this page.
