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

Purpose

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).

Condition

  • Ulcerative Colitis

Eligibility

Eligible Ages
Between 2 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mirikizumab Weight-Based Group 1 		Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).
  • Drug: Mirikizumab IV
    Administered IV
    Other names:
    • LY3074828
  • Drug: Mirikizumab SC
    Administered SC
    Other names:
    • LY3074828
Experimental
Mirikizumab Weight-Based Group 2 		Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.
  • Drug: Mirikizumab IV
    Administered IV
    Other names:
    • LY3074828
  • Drug: Mirikizumab SC
    Administered SC
    Other names:
    • LY3074828
Experimental
Mirikizumab Weight-Based Group 3 		Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.
  • Drug: Mirikizumab IV
    Administered IV
    Other names:
    • LY3074828
  • Drug: Mirikizumab SC
    Administered SC
    Other names:
    • LY3074828

Recruiting Locations

Massachusetts General Hospital for Children
Boston 4930956, Massachusetts 6254926 02114
Contact:
617-726-2000

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
clinical_inquiry_hub@lilly.com

Detailed Description

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