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Looking for participantsPhase3

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

Sponsor: Eli Lilly and Company

NCT ID: NCT04844606

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Mirikizumab (drug), Mirikizumab (drug)
How long the study runs
Study runs about 115 months (dates as stated)
About the drug or intervention
Mirikizumab — drug: Administered SC · Mirikizumab — drug: Administered IV
Patient visit burden
"The study will last about 172 weeks and may include up to 44 visits." (as stated by sponsor)
Type of study
Testing a treatment
Ages
2 Years to 19 Years
Who
All
Number of participants
150
Started
2021-05-26
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for ulcerative colitis
  • • Phase3 - 150 participants
  • • 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)

Who can take part?

  • • Ages 2 Years to 19 Years
  • • Diagnosed with ulcerative colitis

Where?

  • • London - Royal London Hospital
  • • Oxford - The John Radcliffe Hospital
  • • Sheffield - Sheffield Children's Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

Ulcerative ColitisUlcerative Colitis ChronicInflammatory Bowel DiseasesCrohn's Disease

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 2 Years - 19 Years
  • Who can join: All genders

What the study is looking for

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

Who cannot take part

  • ✗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...
  • ✗Participants must not have adenomatous polyps that have not been removed.
  • ✗Participants must not be pregnant or breastfeeding.
See the full 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 * 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 Criteria: * 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.

Where Is This Study? (3 UK sites)

Royal London Hospital

London E1 1BB, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Ahmed KadirPrincipal Investigator

The John Radcliffe Hospital

Oxford OX3 9DU, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Lucy HowarthPrincipal Investigator

Sheffield Children's Hospital

Sheffield S10 2TH, United Kingdom

Recruiting
Site contact (verified)
Akshay KapoorPrincipal Investigator

How to Get in Touch

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

Sponsor contact

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

Sponsor contact

CONTACT

clinical_inquiry_hub@lilly.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10