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

In plain English

What this trial is testing

This study is testing Mirikizumab (a drug) as a possible treatment. Condition(s) listed: Crohn's Disease.

It is open-label: participants know what they are receiving.

Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.

Who can join

• Ages 2 to 17
• Any sex

Some of the main requirements, copied from the record:

• 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…

There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 90 participants are expected to take part.
• The study has 3 groups.
• Start date: 2024-03-13.
• Main results expected around 2027-12 (estimate from the record).
• 81 study sites listed (71 marked recruiting) in Austria, Belgium, Brazil, Canada and France and 11 more countries.

Groups in this study

• Mirikizumab Dose 1 (listed as: experimental group)
• Mirikizumab Dose 2 (listed as: experimental group)
• Mirikizumab Dose 3 (listed as: experimental group)

Main thing being measured

• Percentage of Participants with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52 (Baseline to Week 52)
• Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52 (Baseline to Week 52)

In the researchers’ words

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…

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.