RECRUITING

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

Description

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.

Conditions

Ulcerative ColitisUlcerative Colitis ChronicInflammatory Bowel DiseasesCrohn's Disease
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Related Conditions:

Ulcerative ColitisUlcerative Colitis ChronicInflammatory Bowel DiseasesCrohn's Disease

Study Overview

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Study Details

Study 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.

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

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

Condition
Ulcerative Colitis
Intervention / Treatment

-

Contacts and Locations

San Francisco

UCSF Medical Center at Mission Bay, San Francisco, California, United States, 94158

Hartford

Connecticut Children's Medical Center, Hartford, Connecticut, United States, 06106

Atlanta

Emory University School of Medicine, Atlanta, Georgia, United States, 30322

Atlanta

Children's Center for Digestive Health Care, LLC, Atlanta, Georgia, United States, 30342

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Waltham

Massachusetts General Hospital, Waltham, Massachusetts, United States, 02451

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Fort Worth

Cook Children's Medical Center, Fort Worth, Texas, United States, 76104

Fairfax

Pediatric Specialists of Virginia, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

2 Years to 19 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2030-12