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

Phase 3

Recruiting

• Conditions: Ulcerative Colitis; Ulcerative Colitis Chronic; Crohn's Disease; Inflammatory Bowel Diseases
• Interventions: Drug: Mirikizumab

• Registration Number: NCT04844606
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-14
• Study Start: 2021-05-26
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-08
• Primary Completion: 2030-12
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirikizumab Dose 1 for UC	Mirikizumab	Dose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight.
Mirikizumab Dose 2 for UC	Mirikizumab	Dose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Mirikizumab Dose 4 for CD	Mirikizumab	Dose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Mirikizumab Dose 3 for UC	Mirikizumab	Dose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Mirikizumab Dose 5 for CD	Mirikizumab	Dose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Mirikizumab Dose 6 for CD	Mirikizumab	Dose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Mirikizumab Dose 7 for UC or CD	Mirikizumab	Intravenous (IV) rescue dosing, if response is lost.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission	Week 52	Clinical Remission based on the MMS
Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission	Week 52	Clinical Remission based on the PCDAI

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Over Time in C-reactive Protein, High Sensitivity (hsCRP)	Baseline, Week 0 to Week 52
Percentage of Participants with UC in MMS Clinical Response	Week 52	Clinical Response based on the MMS
Percentage of Participants with CD in PCDAI Clinical Response	Week 52	Clinical Response based on the PCDAI
Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response	Week 52	Clinical Response based on the PUCAI
Percentage of Participants with UC in PUCAI Clinical Remission	Week 52	Clinical Response based on the PUCAI
Percentage of Participants with UC in Endoscopic Remission	Week 52	Endoscopic Remission based on the Endoscopic Subscore (ES)
Percentage of Participants with CD in Endoscopic Remission	Week 52	Endoscopic Remission in Participants based on the Simple Endoscopic Score for Crohn's Disease (SES-CD)
Percentage of Participants with UC in Endoscopic Response	Week 52	Endoscopic Response in Participants based on the ES
Percentage of Participants with CD in Endoscopic Response	Week 52	Endoscopic Response based on the SES-CD
Percentage of Participants with UC in having Endoscopic Subscore = 0	Week 52	Endoscopic Remission when ES = 0
Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission	Week 52	Histologic remission based on histology scoring and endoscopic remission based on endoscopy score
Percentage of Participants with CD Achieving Histologic Remission	Week 52	Histologic remission based on histology scoring
Percentage of Participants with UC in Corticosteroid-free Remission Without Surgery	Week 52	Corticosteroid-free Remission based on MMS in participants who did not have an ulcerative colitis (UC)-related surgery
Percentage of Participants with CD in Corticosteroid-free Remission Without Surgery	Week 52	Corticosteroid-free Remission based on PCDAI in participants who did not have Crohn's disease (CD-related surgery)
Time to First Dose of Corticosteroid Among Participants with UC Entering Study AMAZ Not on Corticosteroids	Week 0 to Week 52
Percentage of Participants Who Achieve both Clinical Remission by PCDAI and Endoscopic Response	Week 52

Trial Locations

Locations (60)

UCSF Medical Center at Mission Bay; 🇺🇸 San Francisco, California, United States

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

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Children's Center for Digestive Health Care, LLC; 🇺🇸 Atlanta, Georgia, United States

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

Massachusetts General Hospital; 🇺🇸 Waltham, Massachusetts, United States

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

Cook Children's Medical Center; 🇺🇸 Fort Worth, Texas, United States

Pediatric Specialists of Virginia; 🇺🇸 Fairfax, Virginia, United States

Medizinische Universität Wien; 🇦🇹 Vienna, Wien, Austria

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