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

Phase 3

Recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: Mirikizumab IV; Drug: Mirikizumab SC

• Registration Number: NCT05784246
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-24
• Study Start: 2023-11-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-05
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Males or females weighing ≥10 kg and ≥2 and <18 years old at the time of consent for screening.
• Have moderate to severe UC.
• Have failed corticosteroids, biologics, (for example, anti-tumor necrosis factor (TNF) antibodies or anti-integrin antibodies), immunomodulators (for example, azathioprine, thiopurines or methotrexate) 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirikizumab Weight-Based Group 3	Mirikizumab IV	Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.
Mirikizumab Weight-Based Group 1	Mirikizumab IV	Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).
Mirikizumab Weight-Based Group 1	Mirikizumab SC	Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).
Mirikizumab Weight-Based Group 3	Mirikizumab SC	Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.
Mirikizumab Weight-Based Group 2	Mirikizumab IV	Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.
Mirikizumab Weight-Based Group 2	Mirikizumab SC	Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab	Baseline to Week 52	PK: AUC of Mirikizumab
PK: Cmax of Mirikizumab	Baseline to Week 52
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 MMS Clinical 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 Achieving PUCAI Clinical Remission	Week 52
Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement	Week 52
Percentage of Participants Achieving MMS Clinical Response	Week 52
Percentage of Participants Achieving PUCAI Clinical Response	Week 52
Percentage of Participants Achieving Endoscopic Remission	Week 52

Trial Locations

Locations (56)

Rady Children's Hospital- San Diego; 🇺🇸 San Diego, California, United States

University of California-San Francisco-Mission Bay; 🇺🇸 San Francisco, California, United States

Connecticut Children's Medical Center; 🇺🇸 Hartford, Connecticut, United States

GI Care for Kids; 🇺🇸 Atlanta, Georgia, United States

Riley Childrens Hospital; 🇺🇸 Indianapolis, Indiana, United States

Massachusetts General Hospital for Children; 🇺🇸 Boston, Massachusetts, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

St. Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States

Morristown Medical Center; 🇺🇸 Morristown, New Jersey, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

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