A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis

a study on Inflammatory Bowel Disease Ulcerative Colitis

Summary

Eligibility
for people ages 2-17 (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Sofia Verstraete (ucsf)
Headshot of Sofia Verstraete
Sofia Verstraete

Description

Summary

The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).

Official Title

A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age With Moderately to Severely Active Ulcerative Colitis

Details

Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).

Keywords

Ulcerative Colitis, Colitis, Ulcer, Mirikizumab, Mirikizumab IV, Mirikizumab SC

Eligibility

You can join if…

Open to people ages 2-17

  • Males or females weighing ≥10 kg and ≥2 and <18 years old at the time of consent for screening.
  • Have moderate to severe UC.
  • Have failed corticosteroids, biologics, (for example, anti-tumor necrosis factor (TNF) antibodies or anti-integrin antibodies), immunomodulators (for example, azathioprine, thiopurines or methotrexate) or Janus Kinase (JAK)-Inhibitor treatment.
  • Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report.

You CAN'T join if...

Locations

  • University of California-San Francisco-Mission Bay accepting new patients
    San Francisco California 94158 United States
  • Rady Children's Hospital- San Diego not yet accepting patients
    San Diego California 92123 United States
  • St. Louis Children's Hospital accepting new patients
    Saint Louis Missouri 63110 United States

Lead Scientist at University of California Health

  • Sofia Verstraete (ucsf)
    Associate Professor, Pediatrics, School of Medicine. Authored (or co-authored) 29 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis (SHINE-2)
ID
NCT05784246
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated