A Multicenter, Phase 3b, Open-Label, Single-Arm Study to Investigate Bowel Urgency and Its Relationship With Other Outcome Measures in Adults With Moderately to Severely Active Ulcerative Colitis Treated With Mirikizumab

18551

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.

2023-05-17

2024-12-09

2025-03-31

Recruiting

Early phase I

160

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}

2024-03-08