A Study to Investigate Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age with Moderately to Severely Active Ulcerative Colitis
Phase 1
Recruiting
- Conditions
- Moderately to Severely Active Ulcerative ColitisMedDRA version: 20.0Level: PTClassification code: 10009900Term: Colitis ulcerative Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2022-502183-20-00
- Lead Sponsor
- Eli Lilly & Co.
- 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method