At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,158 enrolled
Drug / intervention
Mirikizumab +5 moredrug
Likely dose
Not stated in 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 Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease
In Brief
A Phase 3 clinical trial evaluating Mirikizumab, Ustekinumab, and 1 other intervention for Crohn's Disease. Completed, enrolled 1,158 participants across 580 sites in 34 countries.
Detailed Summary
The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartJul 2019
Primary CompletionAug 2023
Study CompletionOct 2023
TodayJul 2026
First PostedApr 24, 2019
Enrollment StartJul 23, 2019
Primary CompletionAug 23, 2023
Study CompletionOct 2, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.2 years ago
Interventions
Mirikizumabdrug
Administered IV
Mirikizumabdrug
Administered SC
Ustekinumabdrug
Administered IV
Ustekinumabdrug
Administered SC
Placebodrug
Administered IV
Placebodrug
Administered SC