Last updated 15 days ago
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
90 patients around the world
Available in Spain, Brazil, United States
Participants screened in the MACARONI-23 Platform study could be randomized to
mirikizumab to participate in this intervention specific arm of the study.
Eli Lilly and Company
6Research sites
90Patients around the world
This study is for people with
Crohn's disease
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- 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.
Sites
Hospital das Clínicas da Universidade Federal de Goiás - UFG
Recruiting
Instituto de Proteção à Infância Dr. Raul Carneiro
Recruiting
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Recruiting
Hospital da Criança Santo Antônio
Recruiting
Hospital e Maternidade Celso Pierro
Recruiting
INTEGRAL Pesquisa e Ensino
Recruiting
StudyAMAY
SponsorEli Lilly and Company
Conditions
Crohn's disease
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05509777
