A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) (SHINE-ON)
Ulcerative Colitis, Ulcerative Colitis Chronic, Inflammatory Bowel Diseases
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Pediatric Ulcerative Colitis, Pediatric Crohn's Disease, Pediatric UC, Pediatric CD
Eligibility Criteria
Inclusion Criteria:
- Participants from originating studies (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.
Sites / Locations
- Icahn School of Medicine at Mount SinaiRecruiting
- Children's Hospital of The King's DaughtersRecruiting
- Shaare Zedek Medical Center
- Juntendo University HospitalRecruiting
- Tokyo Medical And Dental University Medical HospitalRecruiting
- Seoul National University Hospital
- Kyungpook National University Chilgok Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Mirikizumab Dose 1 for UC
Mirikizumab Dose 2 for UC
Mirikizumab Dose 3 for UC
Mirikizumab Dose 4 for CD
Mirikizumab Dose 5 for CD
Mirikizumab Dose 6 for CD
Mirikizumab Dose 7 for UC or CD
Dose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight.
Dose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Dose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Dose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Dose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Dose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Intravenous (IV) rescue dosing, if response is lost.