A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 90
- Locations
- 147
- Primary Endpoint
- 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
Study Overview
Brief Summary
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.
Detailed Description
Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Mirikizumab Dose 2
Mirikizumab administered IV or SC in participants that weigh >20 kg to less than or equal to (≤) 40 kg.
Dosing is based on assessments of the participant's weight and appropriate weight class.
Intervention: Mirikizumab (Drug)
Mirikizumab Dose 1
Mirikizumab administered intravenously (IV) or subcutaneously (SC) in participants that weigh greater than (>) 40 kilograms (kg).
Intervention: Mirikizumab (Drug)
Mirikizumab Dose 3
Mirikizumab administered IV or SC in participants that weigh greater than or equal to (≥) 9 kg to less than or equal to ≤20 kg.
Dosing is based on assessments of the participant's weight and appropriate weight class.
Intervention: Mirikizumab (Drug)
Outcomes
Primary Outcomes
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
Time Frame: Baseline to Week 52
Clinical response based on PCDAI, and endoscopic response based on SES-CD.
Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52
Time Frame: Baseline to Week 52
Clinical response based on PCDAI, and clinical remission based on PCDAI.
Secondary Outcomes
- Percentage of Participants Achieving Endoscopic Response(Week 52)
- Pharmacokinetics (PK): Clearance of Mirikizumab(Baseline through Week 52)
- Pharmacokinetics (PK): Volume of Distribution of Mirikizumab(Baseline through Week 52)
- Change from Baseline in CRP(Baseline, Week 52)
- Change from Baseline in Fecal calprotectin(Baseline, Week 52)
- Percentage of Participants Achieving Clinical Response by PCDAI(Week 12)
- Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI)(Week 12)
- Percentage of Participants Achieving Clinical Remission by PCDAI(Week 52)
- Percentage of Participants Achieving Clinical Remission by CDAI(Week 12)
- Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and Endoscopic Remission by SES-CD at Week 52(Baseline to Week 52)
- Change from Baseline in C-reactive Protein (CRP)(Baseline, Week 12)
- Percentage of Participants Achieving Clinical Response PCDAI at Week 12 and Clinical Remission by CDAI at Week 52(Baseline to Week 52)
- Percentage of Participants Achieving Clinical Response by PCDAI(Week 12)
- Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI)(Week 12)
- Percentage of Participants Achieving Clinical Remission by PCDAI(Week 52)
- Percentage of Participants Achieving Clinical Remission by CDAI(Week 12)
- Percentage of Participants Who Achieve PCDAI Clinical Response at Week 12 and PCDAI Clinical Remission and Endoscopic Remission at Week 52(Baseline to Week 52)
- Percentage of Participants Who Achieve PCDAI Clinical Remission and Endoscopic Remission at Week 52(Week 52)
- Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and Endoscopic Remission by SES-CD at Week 52(Baseline to Week 52)
- Change from Baseline in C-reactive Protein (CRP)(Baseline, Week 12)
- Change from Baseline in CRP(Baseline, Week 52)
- Change from Baseline in Fecal calprotectin(Baseline, Week 52)
- Percentage of Participants Achieving Clinical Response PCDAI at Week 12 and Clinical Remission by CDAI at Week 52(Baseline to Week 52)
- Percentage of Participants Achieving Endoscopic Response(Week 52)
- Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and PCDAI Clinical Remission without the use of Corticosteroids and Who Did Not Have Crohn's Disease (CD)-Related Surgery at Week 52(Baseline to Week 52)
- Pharmacokinetics (PK): Clearance of Mirikizumab(Baseline through Week 52)
- Pharmacokinetics (PK): Volume of Distribution of Mirikizumab(Baseline through Week 52)
- Percentage of Participants Achieving Clinical Remission by PCDAI(Week 12)
- Change from Baseline in Fecal calprotectin(Baseline, Week 12)