RECRUITING

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

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Conditions

Ulcerative ColitisUlcerative Colitis ChronicInflammatory Bowel DiseasesCrohn's DiseasePediatric Ulcerative ColitisPediatric Crohn's DiseasePediatric UCPediatric CD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-05-26
Study Completion:2030-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04844606

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.

Ages Eligible for Study:2 Years to 19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.
  3. * Female participants must agree to contraception requirements.
  1. * 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.
  2. * 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.
  3. * Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.
  4. * 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.
  5. * Participants must not have adenomatous polyps that have not been removed.
  6. * Participants must not be pregnant or breastfeeding.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLilly (1-877-285-4559) or
CONTACT
1-317-615-4559
clinical_inquiry_hub@lilly.com

Principal Investigator

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 Locations (Sites)

UCSF Medical Center at Mission Bay
San Francisco, California, 94158
United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
United States
Emory University School of Medicine
Atlanta, Georgia, 30322
United States
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, 30342
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Massachusetts General Hospital
Waltham, Massachusetts, 02451
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Cook Children's Medical Center
Fort Worth, Texas, 76104
United States
Pediatric Specialists of Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-26
Study Completion Date2030-12

Study Record Updates

Study Start Date2021-05-26
Study Completion Date2030-12

Terms related to this study

Keywords Provided by Researchers

  • Pediatric Ulcerative Colitis
  • Pediatric Crohn's Disease
  • Pediatric UC
  • Pediatric CD

Additional Relevant MeSH Terms

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