Status:
WITHDRAWN
A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis
Lead Sponsor:
Eli Lilly and Company
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04469062
Start Date
April 20 2021
End Date
June 5 2024
Last Update
May 6 2021
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