A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT05784246
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Males or females weighing >10 kg and =2 and <18 years old<br><br> - Have moderate to severe UC<br><br> - Have failed corticosteroids, biologics, anti-TNF antibodies or anti-integrin<br> antibodies, or Janus Kinase (JAK)-Inhibitor treatment<br><br> - Have UC at least 3 months in duration before baseline, which includes endoscopic<br> evidence of UC corroborated by a histopathology report<br><br>Exclusion Criteria:<br><br> - Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis<br> or primary sclerosing cholangitis<br><br> - Have immune deficiency syndrome<br><br> - Previous bowel resection or intestinal surgery<br><br> - Evidence of toxic megacolon<br><br> - History or current evidence of cancer of the gastrointestinal tract
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders
- Secondary Outcome Measures
Name Time Method