A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

  • STATUS
    Recruiting
  • End date
    Sep 23, 2027
  • participants needed
    185
  • sponsor
    Eli Lilly and Company
Updated on 24 October 2021
ulcerative colitis
crohn's disease
colitis
ulceration
ulcerative colitis or crohn's
mirikizumab

Summary

The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits.

Details
Condition Gastroenteritis, Intestinal Diseases, Ulcerative Colitis, Inflammatory bowel disease, Crohn's Disease, Ulcerative Colitis Chronic, inflammatory bowel diseases, crohns disease
Treatment Mirikizumab
Clinical Study IdentifierNCT04844606
SponsorEli Lilly and Company
Last Modified on24 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants from originating studies (I6T-MC-AMBU [NCT04004611]) who should, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab
Participants from prior studies who have had at least one study drug administration and have not had early termination of study drug
Female participants must agree to contraception requirements

Exclusion Criteria

Participants must not have developed a new condition, including cancer in the originator study
Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study
Participants must not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study
Participants must not require parenteral nutrition delivered by central vein and/or central venous catheter for venous access
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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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