Purpose

This study is designed to evaluate how the body processes and removes mirikizumab. The study will also evaluate safety and disease response in pediatric participants with UC taking mirikizumab. The study will last about 52 weeks and may include up to 17 visits.

Condition

Eligibility

Eligible Ages
Between 2 Years and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants weighing >10 kg - Participants must have a diagnosis of ulcerative colitis for at least 3 months before the planned start date for the study medications - Have moderately to severely active UC as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of study treatment - Have evidence of UC extending proximal to the rectum - Participants have demonstrated an inadequate response to, a loss of response to, or an intolerance to corticosteroids, immunomodulators, Janus kinase inhibitor (JAK-inhibitor) or to biologic therapies for UC

Exclusion Criteria

  • Participants with a current diagnosis of Crohn's disease, inflammatory bowel disease-unclassified (indeterminate colitis), ulcerative proctitis, or primary sclerosing cholangitis - Participants must not have had surgery to remove part of their colon - Participants with current evidence of toxic megacolon - Have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening; corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 1 week of screening - Inadequate response to Interleukin 12 p40 subunit antibody (anti-IL12p40) (e.g. ustekinumab) or had prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mirikizumab Dose 1
Mirikizumab administered intravenously (IV) and Subcutaneously (SC). Participants >40 kilograms (kg)
  • Drug: Mirikizumab
    Administered IV and SC
    Other names:
    • LY3074828
Experimental
Mirikizumab Dose 2
Mirikizumab administered IV and SC. Participants ≤40 kg
  • Drug: Mirikizumab
    Administered IV and SC
    Other names:
    • LY3074828
Experimental
Mirikizumab Dose 3
Mirikizumab administered IV and SC. Participants ≤40 kg
  • Drug: Mirikizumab
    Administered IV and SC
    Other names:
    • LY3074828

Recruiting Locations

MGH for Children - Waltham
Waltham, Massachusetts 02451
Contact:
617-726-4042

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
clinicaltrials.gov@lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.