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
- Edinburgh, Headington, London, Manchester, Sheffield, and Whitechapel, United KingdomSee the 6 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with moderately to severely active Crohn's disease. They must have had an inadequate response or intolerance to at least one Crohn's medicine.
- Age
- 2 Years to 17 Years
- Sex
- All sexes can join.
- Disease stage
- Crohn's disease or fistulizing Crohn's disease with active colitis, ileitis, or ileocolitis. Disease must be moderately to severely active (PCDAI score ≥30). Endoscopy must show active disease (SES-CD score ≥6, or ≥4 for isolated ileal disease) within 1 month of starting the study intervention at Week 0.
- Earlier treatment
- Must have a documented history of inadequate response, loss of response or intolerance to at least one medicine for Crohn's disease. This may be an immunomodulator, oral or IV corticosteroid, a biologic therapy or a JAK inhibitor.
Main reasons for not taking part
- Complications of Crohn's disease such as symptomatic strictures or stenosis, short gut syndrome, or other problems likely to need surgery
- An abscess
- Any bowel resection within 26 weeks
- Any other surgery inside the abdomen within 12 weeks of baseline
Read by machine on 12 November 2026.
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 United Kingdom
- Royal Hospital for Children and Young PeopleEdinburgh, United KingdomContact: Richard Russell (principal investigator)Taking people
- Oxford University Hospitals NHS trust John Radcliffe hospitalHeadington, United KingdomContact: Lucy Howarth (principal investigator)Taking people
- Great Ormond Street Hospital For Children NHS Foundation TrustLondon, United KingdomContact: Kelsey Jones (principal investigator)Taking people
- Manchester University NHS Foundation TrustManchester, United KingdomContact: Andrew Fagbemi (principal investigator)Taking people
- Sheffield Children's HospitalSheffield, United KingdomContact: Akshay Kapoor (principal investigator)Taking people
- Royal London HospitalWhitechapel, United KingdomContact: Ahmed Kadir (principal investigator)Taking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.