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

  • STATUS
    Recruiting
  • End date
    Apr 21, 2023
  • participants needed
    1150
  • sponsor
    Eli Lilly and Company
Updated on 26 September 2021
Investigator
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Primary Contact
Clinical Center Zemun (3.0 mi away) Contact
+1004 other location
ustekinumab
crohn's disease

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.

Details
Condition Inflammatory bowel disease, Crohn's Disease, Crohn's Disease (Pediatric), crohns disease
Treatment Placebo, Mirikizumab, ustekinumab
Clinical Study IdentifierNCT03926130
SponsorEli Lilly and Company
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clear my responses

How to participate?

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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