An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Alone or with Mirikizumab for Moderately to Severely Active Ulcerative Colitis in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of two drugs, eltrekibart and mirikizumab, in adults with moderately to severely active ulcerative colitis UC. This phase 2 study focuses on how these medications work alone or in combination for people who have had UC for at least three months and have not responded well or tolerated previous treatments. The trial is sponsored by Eli Lilly and Company and aims to improve treatment options for this condition. Participants may receive eltrekibart alone, mirikizumab alone, both drugs together, or placebos in various combinations. The study uses a randomized, double-blind design to compare these different treatment groups. The trial lasts about 69 weeks, including a screening period up to 35 days before enrollment. Treatments are administered throughout the study, with doses adjusted as needed to assess safety and effectiveness. During the trial, participants will undergo regular assessments including clinical remission rates at 12 and 52 weeks, endoscopic and histologic evaluations, and quality of life questionnaires. Blood tests will measure drug levels to monitor pharmacokinetics. Safety and response to treatment will be closely monitored throughout the study, which spans approximately 4 to 5 years in total. Participants will have multiple visits for evaluations to track their progress and any side effects.

A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis