A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ulcerative Colitis, Ulcerative Colitis Chronic, Inflammatory Bowel Diseases, Crohn's Disease

Intervention / Treatment
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* Drug: Mirikizumab
* Drug: Mirikizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirikizumab Dose 1 for UC<br>Dose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight. | Drug: Mirikizumab<br>* Administered SC<br>* Other names: LY3074828;|
| Experimental: Mirikizumab Dose 2 for UC<br>Dose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight. | Drug: Mirikizumab<br>* Administered SC<br>* Other names: LY3074828;|
| Experimental: Mirikizumab Dose 3 for UC<br>Dose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight. | Drug: Mirikizumab<br>* Administered SC<br>* Other names: LY3074828;|
| Experimental: Mirikizumab Dose 4 for CD<br>Dose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight. | Drug: Mirikizumab<br>* Administered SC<br>* Other names: LY3074828;|
| Experimental: Mirikizumab Dose 5 for CD<br>Dose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight. | Drug: Mirikizumab<br>* Administered SC<br>* Other names: LY3074828;|
| Experimental: Mirikizumab Dose 6 for CD<br>Dose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight. | Drug: Mirikizumab<br>* Administered SC<br>* Other names: LY3074828;|
| Experimental: Mirikizumab Dose 7 for UC or CD<br>Intravenous (IV) rescue dosing, if response is lost. | Drug: Mirikizumab<br>* Administered IV<br>* Other names: LY3074828;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission | Clinical Remission based on the MMS | Week 52 | 
| Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission | Clinical Remission based on the PCDAI | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with UC in MMS Clinical Response | Clinical Response based on the MMS | Week 52 | 
| Percentage of Participants with CD in PCDAI Clinical Response | Clinical Response based on the PCDAI | Week 52 | 
| Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response | Clinical Response based on the PUCAI | Week 52 | 
| Percentage of Participants with UC in PUCAI Clinical Remission | Clinical Response based on the PUCAI | Week 52 | 
| Percentage of Participants with UC in Endoscopic Remission | Endoscopic Remission based on the Endoscopic Subscore (ES) | Week 52 | 
| Percentage of Participants with CD in Endoscopic Remission | Endoscopic Remission in Participants based on the Simple Endoscopic Score for Crohn's Disease (SES-CD) | Week 52 | 
| Percentage of Participants with UC in Endoscopic Response | Endoscopic Response in Participants based on the ES | Week 52 | 
| Percentage of Participants with CD in Endoscopic Response | Endoscopic Response based on the SES-CD | Week 52 | 
| Percentage of Participants with UC in having Endoscopic Subscore = 0 | Endoscopic Remission when ES = 0 | Week 52 | 
| Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission | Histologic remission based on histology scoring and endoscopic remission based on endoscopy score | Week 52 | 
| Percentage of Participants with CD Achieving Histologic Response | Histologic response based on histology scoring | Week 52 | 
| Percentage of Participants with UC in Corticosteroid-free Remission Without Surgery | Corticosteroid-free Remission based on MMS in participants who did not have an ulcerative colitis (UC)-related surgery | Week 52 | 
| Percentage of Participants with CD in Corticosteroid-free Remission Without Surgery | Corticosteroid-free Remission based on PCDAI in participants who did not have Crohn's disease (CD-related surgery) | Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Ulcerative Colitis, Pediatric Crohn's Disease, Pediatric UC, Pediatric CD