A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
Phase 3
Recruiting
- Conditions
- lcerative Colitis
- Registration Number
- JPRN-jRCT2031230330
- Lead Sponsor
- Masaki Takeshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
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
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 [ Time Frame: Baseline to Week 52 ]
- Secondary Outcome Measures
Name Time Method