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

Phase 3RecruitingNCT04844606

Eli Lilly and Company150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 2 YearsMax age: 19 Years

Medical Language ↔ Plain English

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.

Locations (61)

UCSF Medical Center at Mission Bay

San Francisco, California, United States

RECRUITING

Connecticut Children's Medical Center

Hartford, Connecticut, United States

RECRUITING

Emory University School of Medicine

Atlanta, Georgia, United States

RECRUITING

Children's Center for Digestive Health Care, LLC

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission

Clinical Remission based on the MMS

Time frame: Week 52

Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission

Clinical Remission based on the PCDAI

Time frame: Week 52

Secondary Outcomes

Percentage of Participants with UC in MMS Clinical Response

Clinical Response based on the MMS

Time frame: Week 52

Percentage of Participants with CD in PCDAI Clinical Response

Clinical Response based on the PCDAI

Time frame: Week 52

Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response

Clinical Response based on the PUCAI

Time frame: Week 52

Percentage of Participants with UC in PUCAI Clinical Remission

Clinical Response based on the PUCAI

Time frame: Week 52

Percentage of Participants with UC in Endoscopic Remission

Endoscopic Remission based on the Endoscopic Subscore (ES)

Time frame: 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)

Time frame: Week 52

Percentage of Participants with UC in Endoscopic Response

Endoscopic Response in Participants based on the ES

Time frame: Week 52

Percentage of Participants with CD in Endoscopic Response

Endoscopic Response based on the SES-CD

Time frame: Week 52

Percentage of Participants with UC in having Endoscopic Subscore = 0

Endoscopic Remission when ES = 0

Time frame: Week 52

Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission

Histologic remission based on histology scoring and endoscopic remission based on endoscopy score

Time frame: Week 52

Percentage of Participants with CD Achieving Histologic Remission

Histologic remission based on histology scoring

Time frame: 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

Time frame: 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)

Time frame: Week 52

Time to First Dose of Corticosteroid Among Participants with UC Entering Study AMAZ Not on Corticosteroids

Time frame: Week 0 to Week 52

Percentage of Participants Who Achieve both Clinical Remission by PCDAI and Endoscopic Response

Time frame: Week 52

Change from Baseline Over Time in C-reactive Protein, High Sensitivity (hsCRP)

Time frame: Baseline, Week 0 to Week 52

Central Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com