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Looking for participantsPhase3

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

Sponsor: Eli Lilly and Company

NCT ID: NCT05509777

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Mirikizumab (drug)
How long the study runs
Study runs about 49 months (dates as stated)
About the drug or intervention
Mirikizumab — drug: Administered IV or SC
Patient visit burden
"The study will last about 74 weeks and may include up to 19 visits." (as stated by sponsor)
Type of study
Testing a treatment
Ages
2 Years to 17 Years
Who
All
Number of participants
90
Started
2024-03-13
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for crohn's disease
  • • Phase3 - 90 participants
  • • Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention

Who can take part?

  • • Ages 2 Years to 17 Years
  • • Diagnosed with crohn's disease

Where?

  • • Edinburgh - Royal Hospital for Children and Young People
  • • Headington - Oxford University Hospitals NHS trust John Radcliffe hospital
  • • London - Great Ormond Street Hospital For Children NHS Foundation Trust
  • • Manchester - Manchester University NHS Foundation Trust
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study.

Crohn's Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 2 Years - 17 Years
  • Who can join: All genders

What the study is looking for

  • ✓Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed...
  • ✓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...

Who cannot take part

  • ✗Participants must not have complications of CD such as causing symptoms strictures or stenosis, short gut syndrome, or...
  • ✗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...
See the full criteria
Inclusion Criteria: * 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 Criteria: * 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.

Where Is This Study? (6 UK sites)

Royal Hospital for Children and Young People

Edinburgh EH16 4TJ, United Kingdom

Recruiting
Site contact (verified)
Richard RussellPrincipal Investigator

Oxford University Hospitals NHS trust John Radcliffe hospital

Headington OX3 9DU, United Kingdom

Recruiting
Site contact (verified)
Lucy HowarthPrincipal Investigator

Great Ormond Street Hospital For Children NHS Foundation Trust

London WC1N 3JH, United Kingdom

Recruiting
Site contact (verified)
Kelsey JonesPrincipal Investigator

Manchester University NHS Foundation Trust

Manchester M139WL, United Kingdom

Recruiting
Site contact (verified)
Andrew FagbemiPrincipal Investigator

Sheffield Children's Hospital

Sheffield S10 2RX, United Kingdom

Recruiting
Site contact (verified)
Akshay KapoorPrincipal Investigator

Royal London Hospital

Whitechapel E1 1FR, United Kingdom

Recruiting
Site contact (verified)
Ahmed KadirPrincipal Investigator

How to Get in Touch

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Sponsor contact

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

Sponsor contact

CONTACT

clinical_inquiry_hub@lilly.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10