Overview

A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis

Status:
Withdrawn
Trial end date:
2024-06-05
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate if study drug mirikizumab is safe and effective compared to vedolizumab and placebo in participants with moderately to severely active ulcerative colitis (UC).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Mirikizumab
Vedolizumab
Criteria
Inclusion Criteria:

- Participants must have a diagnosis of UC for at least 3 months prior to baseline

- Participants must have a confirmed diagnosis of moderately or severely active UC, as
assessed by the modified Mayo score (MMS)

- Participants must have demonstrated an inadequate response to, a loss of response to,
or an intolerance to conventional or to biologic therapy for UC

- Participants must, if female, meet the contraception requirements

Exclusion Criteria:

- Participants must not have a current diagnosis of Crohn's disease or inflammatory
bowel disease-unclassified (indeterminate colitis)

- Participants must not have had a previous colectomy

- Participants must not have current evidence of toxic megacolon

- Participants must not have prior exposure to anti-IL-23p19 antibodies (e.g.
risankizumab, brazikumab, guselkumab or tildrakizumab), vedolizumab, or natalizumab

- Participants must not have prior clinical failure or intolerance to anti-IL12p40
antibodies (e.g. ustekinumab), anti-integrin antibodies other than vedolizumab and
natalizumab (e.g. etrolizumab) or anti-integrin ligand antibodies (e.g. ontamalimab)
within 4 weeks prior to screening endoscopy