Summary

Eligibility
for people ages 15-80 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Official Title

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease

Keywords

Crohn's Disease Crohn Disease Ustekinumab Mirikizumab

Eligibility

You can join if…

Open to people ages 15-80

  • Diagnosis of CD for at least 3 months prior to baseline
  • Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
  • Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
  • If female, subject must meet the contraception recommendations

You CAN'T join if...

  • Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or short bowel syndrome
  • Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
  • Have a stoma, ileoanal pouch or ostomy
  • Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline
  • Have ever received any monoclonal antibodies binding IL-23

Locations

  • University of California, San Francisco not yet accepting patients
    San Francisco California 94158 United States
  • Care Access - Ygnacio Valley not yet accepting patients
    Walnut Creek California 94598 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
ID
NCT03926130
Phase
Phase 3
Study Type
Interventional
Last Updated