Tests mirikizumab in children with Crohn's disease
Tests mirikizumab, compared with another treatment, in children with Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
Key facts
- Where
- Alexandria, Bergamo, Bologna, Florence, Milan, and Rome, ItalySee the 7 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 17 years old?
Source: NCT05509777, who can take part
Where in Italy
- Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo AlessandriaAlexandria, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- Azienda Unita Sanitaria Locale Di BolognaBologna, ItalyTaking people
- Azienda Ospedaliera Universitaria Meyer IRCCSFlorence, ItalyTaking people
- ASST Fatebenefratelli SaccoMilan, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Ospedale Pediatrico Bambino GesùRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT05509777EU 2024-511472-32-00
- Record updated
- 7 October 2026
- Original description
Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease.Read full original descriptionShow less
A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease
Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease.
Study periods for the intervention-specific appendix (ISA) will be as follows:
* A 12-week induction period * A maintenance period from Week 12 to Week 52, and * A safety follow-up period up to 16 weeks.
The study will last about 74 weeks and may include up to 19 visits.
Inclusion: 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 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 SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0; 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.
Exclusion: Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline; 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.