Health Trials

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

ConditionCrohn's Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-17
SponsorEli Lilly and Company

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mirikizumab

    Drug

    Administered IV or SC

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Mirikizumab Dose 1Experimental treatment 1 intervention
Group B: Mirikizumab Dose 2Experimental treatment 1 intervention
Group C: Mirikizumab Dose 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Clinical response based on PCDAI, and endoscopic response based on SES-CD.

Time frame
Baseline to Week 52
2

Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52

Clinical response based on PCDAI, and clinical remission based on PCDAI.

Time frame
Baseline to Week 52

Secondary outcomes

1

Percentage of Participants Achieving Clinical Response by PCDAI

Clinical response based on PCDAI.

Time frame
Week 12
2

Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI)

Clinical response based on CDAI for participants ≥12 years of age

Time frame
Week 12
3

Percentage of Participants Achieving Clinical Remission by PCDAI

Clinical remission based on PCDAI.

Time frame
Week 12
4

Percentage of Participants Achieving Clinical Remission by CDAI

Clinical remission based on CDAI for participants ≥12 years of age.

Time frame
Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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