Back to search results

Mirikizumab for Pediatric Ulcerative Colitis or Crohn's Disease (SHINE-ON)

This study, called SHINE-ON, is looking at how well mirikizumab works long-term in children and teenagers (ages 2 to 19) who have ulcerative colitis (UC) or Crohn's disease (CD). Mirikizumab is given either as a shot under the skin (SC) or through a vein (IV). To join this study, participants must have been in certain previous mirikizumab studies and the doctor must believe they would benefit from continuing treatment. The main goal is to see what percentage of participants achieve clinical remission (a significant reduction in symptoms) after 52 weeks. The current status of this study is unclear.

Study design
This study plans to enroll 150 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
This study will last about 172 weeks and may involve up to 44 visits. Additional treatment might be available after the study ends.
Compensation
Not stated in the trial record.
Follow-up
The primary goals are measured at Week 52, but the study itself lasts about 172 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04844606

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

Recruiting
PHASE3Ages 2–19InterventionalTreatment
Eli Lilly and Company
~150 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Mirikizumab

At a glance

Recruiting sites
38 of 68 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission
Measured over Week 52
+1 more outcome measured

Conditions

Ulcerative Colitis
Ulcerative Colitis Chronic
Inflammatory Bowel Diseases
Crohn's Disease

Explore related trials

Crohn DiseaseUlcerative Colitis

Where it's being run

68 sites across 24 states
Brazil7
Israel6
Italy6
Japan6
Belgium5
Poland5
Norway4
Spain4

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.
Female participants must agree to contraception requirements.

Exclusion

Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.
Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.
Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.
Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation.
Participants must not have adenomatous polyps that have not been removed.
Participants must not be pregnant or breastfeeding.

What this trial measures

  • Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical RemissionWeek 52

    Clinical Remission based on the MMS

  • Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical RemissionWeek 52

    Clinical Remission based on the PCDAI