Recruiting

Phase 3

MirikizumabA 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

Code:

NCT04844606

Conditions

Ulcerative Colitis

Ulcerative Colitis Chronic

Inflammatory Bowel Diseases

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 2 - 19

Healthy Volunteers: Not accepted

Interventions

Mirikizumab

Study Details

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.

Conditions

Ulcerative Colitis

Ulcerative Colitis Chronic

Inflammatory Bowel Diseases

Crohn's Disease

Study ID

NCT04844606

Start date

May 26, 2021

Status verified date

Aug, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 2 - 19

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mirikizumab Dose 1 for UC

Dose 1 of Mirikizumab is administered subcutaneously (SC)

Dosing is based on the participant's weight.

experimental: Mirikizumab Dose 2 for UC

Dose 2 of Mirikizumab is administered SC

Dosing is based on the participant's weight.

experimental: Mirikizumab Dose 3 for UC

Dose 3 of Mirikizumab is administered SC

Dosing is based on the participant's weight.

experimental: Mirikizumab Dose 4 for CD

Dose 4 of Mirikizumab is administered SC

Dosing is based on the participant's weight.

experimental: Mirikizumab Dose 5 for CD

Dose 5 of Mirikizumab is administered SC

Dosing is based on the participant's weight.

experimental: Mirikizumab Dose 6 for CD

Dose 6 of Mirikizumab is administered SC

Dosing is based on the participant's weight.

experimental: Mirikizumab Dose 7 for UC or CD

Intravenous (IV) rescue dosing, if response is lost.

Interventions

Mirikizumab

Administered SC

Mirikizumab

Administered IV

Primary outcome measure

Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission [ Time Frame: Week 52 ]
Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission [ Time Frame: Week 52 ]

Central Contacts and Locations

Central contacts

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

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

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

UCSF Medical Center at Mission Bay

Recruiting

San Francisco, California, United States, 94158

Principal Investigator:

Sofia Verstraete

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Principal Investigator:

Jeffrey Hyams

Emory University School of Medicine

Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator:

subra kugathasan

Children's Center for Digestive Health Care, LLC

Recruiting

Atlanta, Georgia, United States, 30342

Principal Investigator:

Jeffery Lewis

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

617-355-6058

Principal Investigator:

Athos Bousvaros

Massachusetts General Hospital

Recruiting

Waltham, Massachusetts, United States, 02451

Principal Investigator:

Jess Kaplan

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

314-454-6173

Principal Investigator:

Charles Samson

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

212-241-5415

Principal Investigator:

David Dunkin

Cook Children's Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

682-885-1990

Principal Investigator:

Clifton Huang

The Hospital for Sick Children

Recruiting

Toronto, Canada, M5G 1X8

Principal Investigator:

Thomas Walters

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

Pediatric Ulcerative Colitis
Pediatric Crohn's Disease
Pediatric UC
Pediatric CD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-24.