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).

Conditions

  • Ulcerative Colitis

Recruitment Status

RECRUITING

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 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.

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.

Phase

PHASE3

Gender

ALL

Min Age

2 Years

Max Age

17 Years

Download Date

2025-12-08

Principal Investigator

Athos Bousvaros

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

Primary Contact Information

Contact Info
Athos Bousvaros, MD, MPH
athos.bousvaros@childrens.harvard.edu

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

Intervention

Intervention Type

DRUG

DRUG

Intervention Name

Mirikizumab IV

Mirikizumab SC

Contact

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 athos.bousvaros@childrens.harvard.edu