Master:A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23Pathway to Establish Efficacy in Pediatric Crohn’s Disease (MACARONI-23)ISA:A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn’s Disease - MACARONI-23

Eli Lilly and Company0 个研究点目标入组 90 人开始时间: 2023年2月6日最近更新: 2024年9月2日

适应症

试验速览

暂无简介。

•1.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.
•2.Participants must have moderately to severely active CD (as defined by a baseline PCDAI score >30).
•3.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.
•4.Participants must have a prior or current CD medication history that includes either inadequate response, loss of response to or failure to tolerate current treatment immunomodulators or with oral or IV corticosteroids or have received biologic therapy/JAK inhibitor for the treatment of CD and have a documented history of inadequate response, loss of response (LOR), or intolerance to the biologic therapy/JAK inhibitor.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 90
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. 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.
•2. Participants must not have an abscess.
•3. Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.

发起方