A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
Eli Lilly and Company · NCT04844606
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 2–19 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 150
- US sites recruiting
- 9
- Study start
- May 26, 2021
- Record last updated
- October 7, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Mirikizumab; Mirikizumab
Conditions: Ulcerative Colitis; Ulcerative Colitis Chronic; Inflammatory Bowel Diseases; Crohn's Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
UCSF Medical Center at Mission Bay
San Francisco, CA 94158
Site contact: Sofia Verstraete
Connecticut Children's Medical Center
Hartford, CT 06106
Site contact: Jeffrey Hyams
Emory University School of Medicine
Atlanta, GA 30322
Site contact: subra kugathasan
Children's Center for Digestive Health Care, LLC
Atlanta, GA 30342
Site contact: Jeffery Lewis
Boston Children's Hospital
Boston, MA 02115
Site contact: 617-355-6058
Massachusetts General Hospital
Waltham, MA 02451
Site contact: Jess Kaplan
Washington University School of Medicine
St Louis, MO 63110
Site contact: 314-454-6173
Icahn School of Medicine at Mount Sinai
New York, NY 10029
Site contact: 212-241-5415
Cook Children's Medical Center
Fort Worth, TX 76104
Site contact: 682-885-1990
Study contacts (from the official record)
- 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