At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 172 enrolled / 172 target
Drug / intervention
Mirikizumab +1 moredrug
Likely dose
300 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Mirikizumab for Ulcerative Colitis and Ulcerative Colitis Chronic. Completed, enrolled 172 participants across 120 sites in 10 countries.
Signals
Enrolling slower than its timeline implies
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis, Ulcerative Colitis Chronic
CountriesBelgium, Czechia, France, Germany, Hungary, Italy, Poland, Slovakia, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202420252026
First PostedMar 2023
Enrollment StartMay 2023
Primary CompletionAug 2024
Study CompletionApr 2026
TodayJul 2026
First PostedMar 14, 2023
Enrollment StartMay 17, 2023
Primary CompletionAug 9, 2024
Study CompletionApr 27, 2026
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.3 years ago
Arms & Interventions
300 mg Mirikizumabexperimental
Participants received 300 milligram (mg) mirikizumab every 4 weeks (Q4W) at week 0, 4, and 8 administered intravenously (IV).
Drug: Mirikizumab
Interventions
Mirikizumabdrug
Administered IV
Mirikizumabdrug
Administered Subcutaneously (SC)