Mirikizumab Reduces Disease Activity in Active Crohn’s Disease, Phase 2 Trial Shows

Mirikizumab Reduces Disease Activity in Active Crohn’s Disease, Phase 2 Trial Shows
Treatment with Elli Lilly’s mirikizumab led to a significant reduction in disease activity in moderate and severe Crohn’s disease patients after 12 weeks of treatment, findings from a Phase 2 trial show. Results from the trial were recently discussed in an oral presentation at the 2019 Digestive Disease Week (DDW) medical conference in San Diego. The treatment candidate mirikizumab is a large molecule that blocks the activity of the proinflammatory cytokine interleukin 23 (IL-23), which is believed to be increased and uncontrollably produced in Crohn’s disease patients, leading to inflammation of the gut. The SERENITY trial (NCT02891226) is a multicenter, randomized, placebo-controlled Phase 2 study designed to evaluate mirikizumab’s safety and efficacy in adults with moderately to severely active Crohn’s disease. Participants were randomly assigned to receive a placebo or one of three doses of mirikizumab (200 mg, 600 mg, or 1,000 mg) for 12 weeks. The trial’s main goal is to determine the proportion of subjects achieving a 50% reduction on the Simple Endoscopic Activity Score-Crohn's Disease (SES-CD) at 12 weeks. SES-CD evaluates the size of mucosal ulcers, the ulcerated surface and its extension, and the presence of abnormal narrowing of the gut. Secondary objectives included clinical remission as measured by patient reported outcomes, endoscopic remission, and mirikizumab’s safety. After approximately three months of treatment,
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