Summary

Eligibility
for people ages 2-17 (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
Melvin B Heyman (ucsf)
Photo of Melvin B Heyman
Melvin B Heyman

Description

Summary

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.

Official Title

Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients With Moderately to Severely Active Ulcerative Colitis

Keywords

Ulcerative Colitis Interleukin-23 (IL-23) antibody IL-23p19 Pediatric Colitis Colitis, Ulcerative Ulcer Mirikizumab Mirikizumab Dose 1 Mirikizumab Dose 2 Mirikizumab Dose 3

Eligibility

You can join if…

Open to people ages 2-17

  • 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

You CAN'T join if...

  • 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)

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94158 United States
  • Childrens Hospital of Orange County not yet accepting patients
    Orange California 92868 United States

Lead Scientist at UC Health

  • Melvin B Heyman (ucsf)
    Professor, Pediatrics. Authored (or co-authored) 309 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
ID
NCT04004611
Phase
Phase 2
Study Type
Interventional
Last Updated