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

I6T-MC-AMAM -

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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Clinical Trial Resources

Crohn's + Ulcerative Colitis Research

To learn more about Crohn's and ulcerative colitis and ongoing clinical trials in this area, visit our Crohn's + Ulcerative Colitis Research page.

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Immunology Research

To learn more about immune system conditions and ongoing clinical trials in this area, visit our Immunology Research page.

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Pediatric Research

To learn more about pediatric clinical trials, and access resources for children, young people, and caregivers, visit our Pediatric Research page.

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Clinical Trial Information

A clinical trial helps us learn if a new potential medicine or treatment works and how it works. Clinical trials are also called clinical research studies. To learn more about what to expect when taking part in a clinical trial, visit our Clinical Trial Information page.