A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis

• Status: Not yet recruiting
• Trial end date: 2026-07-20
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).

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

Details

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

Criteria

Inclusion Criteria:

• Males or females weighing >10 kg and ≥2 and <18 years old

• Have moderate to severe UC

• Have failed corticosteroids, biologics, anti-TNF antibodies or anti-integrin antibodies, or Janus Kinase (JAK)-Inhibitor treatment

• Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report

Exclusion Criteria:

• Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis

• Have immune deficiency syndrome

• Previous bowel resection or intestinal surgery

• Evidence of toxic megacolon

• History or current evidence of cancer of the gastrointestinal tract