Mirikizumab for Pediatric Ulcerative Colitis or Crohn's Disease

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

Recruiting Phase 3 Interventional Study
Ulcerative Colitis Ulcerative Colitis Chronic Inflammatory Bowel Diseases Crohn's Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
2 – 19
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for

This trial is looking for children with ulcerative colitis or Crohn's disease who have participated in earlier studies of mirikizumab. Participants will take mirikizumab and will have regular visits over about 172 weeks to check their health and response to the treatment.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have taken part in previous studies of mirikizumab
  • I have completed my last visit in the previous study
  • I am a female and I agree to use contraception

You may not be able to join if

  • I have had a serious or ongoing health issue from the last study
  • I have had to stop treatment with mirikizumab in my previous study
  • I have an uncontrolled illness that could affect my safety
  • I would be unsafe or my results would be unclear if I joined this study
  • I have not removed adenomatous polyps
  • I am pregnant or breastfeeding

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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. Additional treatment may be available to participants via a Continued Access Period.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participants from originating studies (I6T-MC-AMBA \[NCT05784246\], I6T-MC-AMBU \[NCT04004611\], I6T-MC-AMAM \[NCT03926130\]) , I6T-MC-AMAY \[NCT05509777\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab * Partici…
Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

LillyTrials@Lilly.com

CONTACT

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

CONTACT