A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease (SERENITY)

The purpose of this study is to evaluate the safety and effectiveness of the study drug LY3074828 in participants with active Crohn's Disease.

Trial Summary

Age Range
18 - 75 years
Conditions the trial is for
Crohn's Disease
What the trial is testing?
Mirikizumab
Could I receive a Placebo?
Yes
Enrollment Goal
191
Trial Dates
Dec 14, 2016 - Feb 5, 2021
How long will I be in the trial?
Your participation could last approximately 2 years and include 35 visits to the study center.
Trial Phase
II

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:

  • Participant must have active Crohn's Disease (i.e., currently having a flare, or experiencing symptoms)

  • Participant must have had inadequate response or failure to tolerate at least one of the following: amino salicylates; budesonide; systemic corticosteroids; immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate); or prior exposure to biologics for the treatment of Crohn's Disease

Participants Must Not:

  • Participant must not have complications of Crohn's Disease such as strictures, stenosis, or any other manifestation for which surgery might be indicated

  • Participant must not have a diagnosis of any condition affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome

  • Participant must not have had any kind of bowel resection, diversion, or placement of a stoma within 6 months or any other intra-abdominal surgery within 3 months prior to screening

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