A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
- Conditions
- Crohn's Disease
- Registration Number
- JPRN-jRCT2051230129
- Lead Sponsor
- Masaki Takeshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
Participants must have moderately to severely active CD (as defined by a baseline PCDAI score >30).
Participants must have endoscopy with evidence of active CD defined as as SES-CD score >=6 (or >=4 for participants with isolated ileal disease) during screening into this study.
Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.
Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery.
Participants must not have an abscess.
Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method