A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
About the study
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).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Ulcerative Colitis
Age
2 - 17
Phase
PHASE3
Participants Needed
60
Est. Completion Date
Mar 31, 2027
Treatment Type
INTERVENTIONAL
Sponsor
Eli Lilly and Company
ClinicalTrials.gov NCT Identifier
NCT05784246
Study Number
I6T-MC-AMBA
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