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NCT Number: NCT04844606

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

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.

Recruiting

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Key information

Age range

2 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medizinische Universität Wien, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mirikizumab

Drug

Administered SC

Other names: LY3074828

Primary outcomes

  1. Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission

    Time frame: Week 52

    Clinical Remission based on the MMS

  2. Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission

    Time frame: Week 52

    Clinical Remission based on the PCDAI

Secondary outcomes

  1. Percentage of Participants with UC in MMS Clinical Response

    Time frame: Week 52

    Clinical Response based on the MMS

  2. Percentage of Participants with CD in PCDAI Clinical Response

    Time frame: Week 52

    Clinical Response based on the PCDAI

  3. Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response

    Time frame: Week 52

    Clinical Response based on the PUCAI

  4. Percentage of Participants with UC in PUCAI Clinical Remission

    Time frame: Week 52

    Clinical Response based on the PUCAI

  5. Percentage of Participants with UC in Endoscopic Remission

    Time frame: Week 52

    Endoscopic Remission based on the Endoscopic Subscore (ES)

  6. Percentage of Participants with CD in Endoscopic Remission

    Time frame: Week 52

    Endoscopic Remission in Participants based on the Simple Endoscopic Score for Crohn's Disease (SES-CD)

  7. Percentage of Participants with UC in Endoscopic Response

    Time frame: Week 52

    Endoscopic Response in Participants based on the ES

  8. Percentage of Participants with CD in Endoscopic Response

    Time frame: Week 52

    Endoscopic Response based on the SES-CD

  9. Percentage of Participants with UC in having Endoscopic Subscore = 0

    Time frame: Week 52

    Endoscopic Remission when ES = 0

  10. Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission

    Time frame: Week 52

    Histologic remission based on histology scoring and endoscopic remission based on endoscopy score

  11. Percentage of Participants with CD Achieving Histologic Remission

    Time frame: Week 52

    Histologic remission based on histology scoring

  12. Percentage of Participants with UC in Corticosteroid-free Remission Without Surgery

    Time frame: Week 52

    Corticosteroid-free Remission based on MMS in participants who did not have an ulcerative colitis (UC)-related surgery

  13. Percentage of Participants with CD in Corticosteroid-free Remission Without Surgery

    Time frame: Week 52

    Corticosteroid-free Remission based on PCDAI in participants who did not have Crohn's disease (CD-related surgery)

  14. Time to First Dose of Corticosteroid Among Participants with UC Entering Study AMAZ Not on Corticosteroids

    Time frame: Week 0 to Week 52

  15. Percentage of Participants Who Achieve both Clinical Remission by PCDAI and Endoscopic Response

    Time frame: Week 52

  16. Change from Baseline Over Time in C-reactive Protein, High Sensitivity (hsCRP)

    Time frame: Baseline, Week 0 to Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease

Acronym: SHINE-ON

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Apr 14, 2021
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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