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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (6 UK sites)
Royal Hospital for Children and Young People
Edinburgh EH16 4TJ, United Kingdom
Oxford University Hospitals NHS trust John Radcliffe hospital
Headington OX3 9DU, United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
London WC1N 3JH, United Kingdom
Manchester University NHS Foundation Trust
Manchester M139WL, United Kingdom
Sheffield Children's Hospital
Sheffield S10 2RX, United Kingdom
Royal London Hospital
Whitechapel E1 1FR, United Kingdom
How to Get in Touch
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Sponsor contactCONTACT
Physicians interested in becoming principal investigators please contact
Sponsor contactCONTACT
