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

ID#: NCT05784246

Age: 2 - 17 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: November 22, 2023

End Date: March 31, 2027

Contact Information:
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
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).
Eligibility:

Inclusion Criteria:

- Males or females weighing ≥10 kg and ≥2 and <18 years old at the time of consent for screening.

- Have moderate to severe UC.

- Have failed corticosteroids, biologics, (for example, anti-tumor necrosis factor (TNF) antibodies or anti-integrin antibodies), immunomodulators (for example, azathioprine, thiopurines or methotrexate) 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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