A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (VIVID-1)

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.

Trial Summary

Age Range
15 - 80 years
Conditions the trial is for
Crohn's Disease
What the trial is testing?
Mirikizumab, Ustekinumab
Could I receive a Placebo?
Yes
Enrollment Goal
1158
Trial Dates
Jul 23, 2019 - Oct 2, 2023
How long will I be in the trial?
The study will last about 73 weeks and may include up to 19 visits.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participants must have a diagnosis of Crohn's Disease (CD) for at least 3 months prior to baseline

  • Participants must have a confirmed diagnosis of moderate to severe CD

  • Participants must have demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD

  • Participants must, if female, meet the contraception recommendations

Participants Must Not:

  • Participants must not have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or short bowel syndrome

  • Participants must not have a stoma, ileoanal pouch or ostomy

  • Participants must not have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline

  • Participants must not have ever received any monoclonal antibodies binding IL-23

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