A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis

• Status: Recruiting
• Trial end date: 2023-08-27
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed prior 12-week induction study AMAN (NCT03518086).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Mirikizumab

Criteria

Inclusion Criteria:

• Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.

• Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.

• If female, must meet the contraception requirements.

Exclusion Criteria:

• Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).

• Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.

• Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).

• Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086).

• Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).

• Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.