• A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis

  NCT05784246

  CompletedInterventionalPhase 3Updated Jun 3, 2026
• A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)

  NCT04004611

  CompletedInterventionalPhase 2Updated Mar 26, 2024
• A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

  NCT05509777

  RecruitingInterventionalPhase 3Updated Aug 24, 2026
• A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis

  NCT02589665

  CompletedInterventionalPhase 2Updated Jun 17, 2020
• A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

  NCT04232553

  Active, not recruitingInterventionalPhase 3Updated Aug 11, 2026
• A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

  NCT03519945

  Active, not recruitingInterventionalPhase 3Updated Apr 20, 2026

ClinicalTrials.gov ID

NCT04844606

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

150Estimated

Last Update Posted

Aug 24, 2026Actual

Start Date

May 26, 2021Actual

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2030Estimated

Official 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

Brief Summary

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

• Mirikizumab

Ages Eligible for Study

Child (0-17)Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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.

Primary Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

3293323966