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A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

Study acronym: AMAY
StatusRecruiting
PhasePhase 3
Started2024-03-13
View on ClinicalTrials.gov ↗
Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease. Study periods for the intervention-specific appendix (ISA) will be as follows: * A 12-week induction period * A maintenance period from Week 12 to Week 52, and * A safety follow-up period up to 16 weeks. The study will last about 74 weeks and may include up to 19 visits.

Amendment record

Amended 50 times since 2022-08-19; most recent filed 2026-08-21. The 50 most recent of 51 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 2026-08-30.

2026-08-21
Amendment Study Status v50
2026-08-06
Amendment Study Status, Contacts/Locations v49
2026-05-22
Amendment Study Status v48
2026-03-26
Amendment Study Status, Contacts/Locations v47
2026-03-02
Amendment Study Status, Contacts/Locations v46
2025-12-22
Amendment Study Status, Contacts/Locations v45
2025-12-05
Amendment Study Status, Contacts/Locations v44
2025-10-15
Amendment Study Status, Contacts/Locations v43
2025-10-08
Amendment Study Status, Contacts/Locations v42
2025-09-22
Amendment Study Status, Contacts/Locations v41
2025-09-03
Amendment Study Status, Outcome Measures, Contacts/Locations v40
2025-07-07
Amendment Study Status, Contacts/Locations v39
2025-06-25
Amendment Study Status, Contacts/Locations v38
2025-05-22
Amendment Study Status, Contacts/Locations v37
2025-04-17
Amendment Study Status, Contacts/Locations v36
2025-03-04
Amendment Study Identification, Study Status, Arms and Interventions, Eligibility, Contacts/Locations v35
2025-01-21
Amendment Study Status, Contacts/Locations v34
2024-12-05
Amendment Study Status, Contacts/Locations v33
2024-10-14
Amendment Study Status, Contacts/Locations v32
2024-09-22
Amendment Study Status, Contacts/Locations v31
2024-08-26
Amendment Study Status, Contacts/Locations v30
2024-07-18
Amendment Study Status, Contacts/Locations v29
2024-06-17
Amendment Study Status, Contacts/Locations v28
2024-05-19
Amendment Study Status, Contacts/Locations v27
2024-04-15
Amendment Study Status, Contacts/Locations v26
2024-03-15
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v25
2023-10-19
Amendment Study Status, Contacts/Locations v24
2023-09-28
Amendment Study Status v23
2023-09-04
Amendment Study Status v22
2023-07-31
Amendment Study Status v21
2023-07-11
Amendment Study Status v20
2023-06-10
Amendment Study Status v19
2023-05-20
Amendment Study Status v18
2023-05-11
Amendment Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v17
2023-05-08
Amendment Study Status v16
2023-04-25
Amendment Study Identification, Study Status v15
2023-04-16
Amendment Study Status v14
2023-04-10
Amendment Study Status v13
2023-03-23
Amendment Study Status v12
2023-03-03
Amendment Study Status v11
2023-02-17
Amendment Study Status v10
2023-02-13
Amendment Study Status v9
2023-01-17
Amendment Study Status v8
2022-12-08
Amendment Study Status v7
2022-11-09
Amendment Study Status v6
2022-10-18
Amendment Study Status v5
2022-10-10
Amendment Study Status, Conditions v4
2022-09-19
Amendment Study Status, References v3
2022-09-16
Amendment Study Status v2
2022-09-07
Amendment Study Status v1
Trial Details
NCT Number NCT05509777
Lead Sponsor Eli Lilly and Company
Conditions Crohn's Disease
Enrollment 90 participants
Start Date 2024-03-13
Primary Completion 2027-12 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2026-08-24