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

Phase 3RecruitingNCT05509777

Eli Lilly and Company90 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Crohn's Disease

Interventions

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (81)

Cedars Sinai Medical Center

Los Angeles, California, United States

NOT_YET_RECRUITING

Connecticut Children's Medical Center

Hartford, Connecticut, United States

RECRUITING

Emory University

Atlanta, Georgia, United States

RECRUITING

Children's Center for Digestive Health Care, LLC

Atlanta, Georgia, United States

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

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

Time frame: Baseline to Week 52

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

Percentage of Participants Achieving Clinical Response by PCDAI

Clinical response based on PCDAI.

Time frame: Week 12

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

Percentage of Participants Achieving Clinical Remission by PCDAI

Clinical remission based on PCDAI.

Time frame: Week 12

Percentage of Participants Achieving Clinical Remission by CDAI

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

Time frame: Week 12

Percentage of Participants Who Achieve PCDAI Clinical Response at Week 12 and PCDAI Clinical Remission and Endoscopic Remission at Week 52

Time frame: Baseline to Week 52

Percentage of Participants Who Achieve PCDAI Clinical Remission and Endoscopic Remission at Week 52

Time frame: Week 52

Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and Endoscopic Remission by SES-CD at Week 52

Time frame: Baseline to Week 52

Change from Baseline in C-reactive Protein (CRP)

Time frame: Baseline, Week 12

Change from Baseline in CRP

Time frame: Baseline, Week 52

Change from Baseline in Fecal calprotectin

Time frame: Baseline, Week 12

Change from Baseline in Fecal calprotectin

Time frame: Baseline, Week 52

Percentage of Participants Achieving Clinical Response PCDAI at Week 12 and Clinical Remission by CDAI at Week 52

Clinical response by PCDAI, CDAI for participants ≥12 years of age

Time frame: Baseline to Week 52

Percentage of Participants Achieving Endoscopic Response

Time frame: Week 52

Percentage of Participants Achieving Clinical Remission by PCDAI

Clinical remission based on PCDAI

Time frame: 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

Clinical response and clinical remission by PCDAI

Time frame: Baseline to Week 52

Pharmacokinetics (PK): Clearance of Mirikizumab

Time frame: Baseline through Week 52

Pharmacokinetics (PK): Volume of Distribution of Mirikizumab

Time frame: Baseline through Week 52

Central Contacts

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

CONTACT

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

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com