Status:
RECRUITING
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
Lead Sponsor:
Eli Lilly and Company
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief 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).
Detailed Description
Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05784246
Start Date
November 22 2023
End Date
August 1 2026
Last Update
March 3 2026
Active Locations (34)
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1
University of California, San Francisco
San Francisco, California, United States, 94158
2
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, United States, 30342
3
Riley Childrens Hospital
Indianapolis, Indiana, United States, 46202
4
Washington University
St Louis, Missouri, United States, 63110-1010