A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
Study Phase: Phase 3
Recruitment Status: Recruiting
Start Date: November 22, 2023
End Date: March 31, 2027
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
1-317-615-4559
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
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Conditions:
- Colitis
- Colitis, Ulcerative
- Ulcer