Study Condition(s): Crohn's Disease

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

Study Alias: AMAG

Study Identifier(s): Tool Tip Icon {{ defaultRegistry.registryAnchorText }} NCT02891226 {{ currentLocaleObject.registryAnchorText }}

Recruiting Recruiting

Study Purpose

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

Key Participation Requirements Tool Tip Icon

All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria

Gender

Male Female

Age

18 years
75 years

Time Commitment

Your participation could last approximately 2 years and include 35 visits to the study center
  • 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
  • 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

Where to Participate

143 locations are currently available of 143 planned
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