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Purpose

This study was designed to evaluate how the body processes and removes mirikizumab. The study also evaluated safety and disease response in pediatric participants with UC taking mirikizumab. The study lasted about 52 weeks and included up to 18 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 - Participants must have moderately to severely active UC as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of study treatment - Participants must have evidence of UC extending proximal to the rectum - Participants must 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 must not have 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 must not have current evidence of toxic megacolon - Participants must not 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 endoscopy - Participants must not have had an 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
Open Label (OL) Induction Period: 5 milligram per kilogram (mg/kg) Miri intravenous (IV) 		Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion every 4 weeks (Q4W) on weeks 0, 4, 8 for 12 weeks.
  • Drug: Mirikizumab
    Administered IV and SC
    Other names:
    • LY3074828
Experimental
Open Label Induction Period: 10 mg/kg Miri IV 		Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
  • Drug: Mirikizumab
    Administered IV and SC
    Other names:
    • LY3074828
Experimental
Open Label Induction Period: 300 mg Miri IV 		Participants (>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
  • Drug: Mirikizumab
    Administered IV and SC
    Other names:
    • LY3074828
Experimental
Open Label Maintenance Period: 50 mg Miri subcutaneous (SC) 		Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed.
  • Drug: Mirikizumab
    Administered IV and SC
    Other names:
    • LY3074828
Experimental
Open Label Maintenance Period: 100 mg Miri SC 		Participants (>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
  • Drug: Mirikizumab
    Administered IV and SC
    Other names:
    • LY3074828
Experimental
Open Label Maintenance Period: 200 mg Miri SC 		Participants (>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
  • Drug: Mirikizumab
    Administered IV and SC
    Other names:
    • LY3074828
Experimental
Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/ 50 mg Miri SC 		Participants (≤40 kg) who were non responders to miri at Week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
  • Drug: Mirikizumab
    Administered IV and SC
    Other names:
    • LY3074828
Experimental
Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/100 mg Miri SC 		Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
  • Drug: Mirikizumab
    Administered IV and SC
    Other names:
    • LY3074828
Experimental
Open Label Maintenance Period: Non-Responders: 300 mg Miri IV /200 mg Miri SC 		Participants (>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
  • Drug: Mirikizumab
    Administered IV and SC
    Other names:
    • LY3074828

More Details

Status
Completed
Sponsor
Eli Lilly and Company

Study Contact

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.