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Completed
NCT05767021
A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis
Conditions: Ulcerative Colitis, Ulcerative Colitis Chronic
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 172
Sponsor: Eli Lilly and Company
Location: Dedicated Clinical Research Litchfield Park Arizona
Summary
A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.
Eligibility Criteria
Inclusion Criteria:
* Have an established diagnosis of UC for ≥3 months
* Have confirmed diagnosis of moderately for severely active UC
* Have current bowel urgency
* Have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic/Janus Kinase (JAK) inhibitor/sphingosine-1-phosphate (S1P) receptor modulator therapy for UC.
Exclusion Criteria:
* Have Crohn's disease (CD)
* Have inflammatory bowel disease-unclassified, formerly known as indeterminate colitis, or
* Have ulcerative proctitis, disease limited to the rectum, that is, distal to the recto-sigmoid junction, which lies approximately 10 to 15 centimeter (cm) from anal verge.
* Have an inherited immunodeficiency syndrome or a monogenic cause of UC-like colonic inflammation
* Have any history or current evidence of cancer of the gastrointestinal tract
* Have active tuberculosis
* Have HIV infection.
Source: ClinicalTrials.gov (NCT05767021). StuddyBuddy aggregates publicly available trial information.