CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 191 enrolled
Drug / intervention
Mirikizumab +1 moredrug
Likely dose
Not stated in record
Key inclusion· 2
  • ✓Active Crohn's Disease as confirmed by SES-CD score plus patient-reported stool frequency and abdominal pain
  • ✓Inadequate response or intolerance to at least one prior therapy: aminosalicylates, budesonide, systemic corticosteroids, immunosuppressants (azathioprine, 6-mercaptopurine, methotrexate), or prior biologic exposure
Key exclusion· 5
  • ✕CD complications: strictures, stenoses, or other manifestations requiring surgery or confounding efficacy evaluation
  • ✕Other GI conditions: ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal/perianal abscess, unexcised adenomatous polyps, colonic dysplasia, short bowel syndrome
  • ✕Bowel resection, diversion, or stoma within 6 months prior to screening
  • ✕Intra-abdominal surgery within 3 months prior to screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02891226
NCT02891226Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects With Active Crohn's Disease (SERENITY)

Eli Lilly and Company·interventional·Posted Sep 7, 2016·Updated Aug 30, 2022

In Brief

A Phase 2 clinical trial evaluating Mirikizumab and Placebo for Crohn's Disease. Completed, enrolled 191 participants across 108 sites in 14 countries.

Detailed Summary

The purpose of this study is to evaluate the safety and effectiveness of the study drug Mirikizumab in participants with active Crohn's Disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustralia, Belgium, Canada, Czechia, Hungary, Japan, Netherlands, Poland, Romania, Russia, Switzerland, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 7, 2016
Enrollment StartDec 14, 2016
Primary CompletionDec 11, 2018
Study CompletionFeb 5, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.8 years ago

Interventions

Mirikizumabdrug

Placebodrug