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

Study acronym: SHINE-ON
StatusRecruiting
PhasePhase 3
Started2021-05-26
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 66 times since 2021-04-12; most recent filed 2026-08-21. The 50 most recent of 67 record versions are listed below. See every version on ClinicalTrials.gov ↗

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-29.

2026-08-21
Amendment Study Status, Contacts/Locations v66
2026-08-06
Amendment Study Status, Contacts/Locations v65
2026-06-19
Amendment Study Status, Contacts/Locations v64
2026-06-02
Amendment Study Status, Contacts/Locations v63
2026-05-22
Amendment Study Status, Contacts/Locations v62
2026-05-13
Amendment Study Status, Contacts/Locations v61
2026-04-16
Amendment Study Status, Contacts/Locations v60
2026-03-26
Amendment Study Status, Contacts/Locations v59
2026-03-02
Amendment Study Status, Contacts/Locations v58
2026-02-09
Amendment Study Status, Contacts/Locations v57
2026-01-12
Amendment Study Status, Contacts/Locations v56
2025-12-23
Amendment Study Status, Contacts/Locations v55
2025-12-05
Amendment Study Status, Contacts/Locations v54
2025-11-21
Amendment Study Status, Contacts/Locations v53
2025-11-04
Amendment Study Status, Contacts/Locations v52
2025-09-22
Amendment Study Status, Contacts/Locations v51
2025-09-08
Amendment Study Status, Contacts/Locations v50
2025-08-21
Amendment Study Status, Contacts/Locations v49
2025-07-22
Amendment Study Status, Contacts/Locations v48
2025-07-07
Amendment Study Status, Contacts/Locations v47
2025-06-18
Amendment Study Identification, Study Status, Study Description, Outcome Measures, Contacts/Locations v46
2025-05-20
Amendment Study Status, Contacts/Locations v45
2025-04-17
Amendment Study Status, Contacts/Locations v44
2025-03-31
Amendment Study Status, Contacts/Locations v43
2025-02-24
Amendment Study Status, Contacts/Locations v42
2025-01-20
Amendment Study Status, Contacts/Locations v41
2024-12-23
Amendment Study Status, Contacts/Locations v40
2024-12-02
Amendment Study Status, Contacts/Locations v39
2024-10-11
Amendment Study Status, Contacts/Locations v38
2024-09-22
Amendment Study Status, Contacts/Locations v37
2024-08-27
Amendment Study Status, Contacts/Locations v36
2024-07-17
Amendment Study Status, Contacts/Locations v35
2024-05-27
Amendment Study Status, Contacts/Locations v34
2024-04-15
Amendment Study Status, Contacts/Locations v33
2024-02-26
Amendment Study Status, Contacts/Locations v32
2024-01-12
Amendment Study Status v31
2023-10-10
Amendment Study Status, Contacts/Locations v30
2023-08-08
Amendment Study Status, Eligibility, Contacts/Locations v29
2023-05-20
Amendment Study Status, Contacts/Locations v28
2023-04-16
Amendment Study Status, Contacts/Locations v27
2023-03-04
Amendment Study Status, Contacts/Locations v26
2022-12-26
Amendment Study Status, Contacts/Locations v25
2022-12-08
Amendment Study Status, Contacts/Locations v24
2022-11-22
Amendment Study Status, Contacts/Locations v23
2022-10-10
Amendment Study Status, Contacts/Locations v22
2022-09-28
Amendment Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v21
2022-08-17
Amendment Study Status, Contacts/Locations v20
2022-06-21
Amendment Study Status, Contacts/Locations v19
2022-06-08
Amendment Study Status, Contacts/Locations v18
2022-05-19
Amendment Study Status, Contacts/Locations v17
Trial Details
NCT Number NCT04844606
Lead Sponsor Eli Lilly and Company
Conditions Ulcerative Colitis, Ulcerative Colitis Chronic, Inflammatory Bowel Diseases, Crohn's Disease
Enrollment 150 participants
Start Date 2021-05-26
Primary Completion 2030-12 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-24