Current Environment:


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).


Ulcerative Colitis

Recruitment Status


Detailed Description

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

Eligibility Criteria

Inclusion Criteria:

Males or females weighing >10 kg and ≥2 and <18 years old
Have moderate to severe UC
Have failed corticosteroids, biologics, anti-TNF antibodies or anti-integrin antibodies, 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

Exclusion Criteria:

Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis
Have immune deficiency syndrome
Previous bowel resection or intestinal surgery
Evidence of toxic megacolon
History or current evidence of cancer of the gastrointestinal tract


Intervention Type

Intervention Name


Mirikizumab IV


Mirikizumab SC


Phase 3



Min Age

2 Years

Max Age

17 Years

Download Date

April 16, 2024

Principal Investigator

Athos Bousvaros

This field has been modified from to show a contact specific to Boston Children's.

Primary Contact Information

Athos Bousvaros, MD, MPH

This field has been modified from to show a contact specific to Boston Children's.

For more information on this trial, visit


For more information and to contact the study team:

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis NCT05784246 Athos Bousvaros, MD, MPH