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

Study Overview
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Brief Summary
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The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).

Detailed Description
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Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).

Official Title
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A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age With Moderately to Severely Active Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Mirikizumab IV
* Drug: Mirikizumab SC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females weighing >10 kg and ≥2 and <18 years old Have moderate to severe UC Have failed corticosteroids, biologics, anti-TNF antibodies or anti-integrin antibodies, or Janus Kinase (JAK)-Inhibitor treatment Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report Exclusion Criteria: Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis Have immune deficiency syndrome Previous bowel resection or intestinal surgery Evidence of toxic megacolon History or current evidence of cancer of the gastrointestinal tract

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 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 Weight-Based Group 1<br>Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC). | Drug: Mirikizumab IV<br>* Administered IV<br>* Other names: LY3074828;Drug: Mirikizumab SC<br>* Administered SC<br>* Other names: LY3074828;|
| Experimental: Mirikizumab Weight-Based Group 2<br>Experimental: Participants will receive mirikizumab weight-based dosing IV or SC. | Drug: Mirikizumab IV<br>* Administered IV<br>* Other names: LY3074828;Drug: Mirikizumab SC<br>* Administered SC<br>* Other names: LY3074828;|
| Experimental: Mirikizumab Weight-Based Group 3<br>Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC. | Drug: Mirikizumab IV<br>* Administered IV<br>* Other names: LY3074828;Drug: Mirikizumab SC<br>* Administered SC<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 modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders |  | Baseline to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants in MMS Clinical Remission |  | Week 12 | 
| Percentage of Participants in MMS Clinical Response |  | Week 12 | 
| Percentage of Participants with Endoscopic Remission |  | Week 12 | 
| Percentage of Participants with Endoscopic Improvement |  | Week 12 | 
| Percentage of Participants Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response |  | Week 12 | 
| Percentage of Participants Achieving PUCAI Clinical Remission |  | Week 12 | 
| Percentage of Participants in Histologic Endoscopic Mucosal Remission |  | Week 12 | 
| Percentage of Participants Achieving MMS Clinical Response |  | Week 52 | 
| Percentage of Participants Achieving MMS Clinical Remission |  | Week 52 | 
| Percentage of Participants Achieving PUCAI Clinical Response |  | Week 52 | 
| Percentage of Participants Achieving PUCAI Clinical Remission |  | Week 52 | 
| Percentage of Participants Achieving Endoscopic Remission |  | Week 52 | 
| Percentage of Participants Achieving Endoscopic Improvement |  | Week 52 | 
| Percentage of Participants Achieving MMS Clinical Remission without Surgery at Week 52 among Clinical Responders at Week 12 and without the Use of Corticosteroids |  | Baseline to Week 52 | 
| Percentage of Participants in Histologic Endoscopic Mucosal Remission |  | Week 52 | 
| Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab | PK: AUC of Mirikizumab | Baseline to Week 52 | 
| PK: Cmax of Mirikizumab |  | Baseline to Week 52 |