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Clinical Trials in Canada / NCT04844606
Recruiting Phase 3

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

NCT04844606 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2021-05-26
Last updated
2026-09-22

Condition(s) studied

Ulcerative ColitisUlcerative Colitis ChronicInflammatory Bowel DiseasesCrohn's Disease

Investigational drug(s) / intervention(s)

Mirikizumab →Mirikizumab →

Mirikizumab: Administered SC

Mirikizumab: Administered IV

Study 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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
19 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (69)

FacilityCityRegionStatus
UCSF Medical Center at Mission Bay San Francisco California Recruiting
Connecticut Children's Medical Center Hartford Connecticut Recruiting
Emory University School of Medicine Atlanta Georgia Recruiting
Children's Center for Digestive Health Care, LLC Atlanta Georgia Recruiting
Boston Children's Hospital Boston Massachusetts Recruiting
Massachusetts General Hospital Waltham Massachusetts Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Icahn School of Medicine at Mount Sinai New York New York Recruiting
Children's Hospital of Philadelphia (CHOP) Philadelphia Pennsylvania Not Yet Recruiting
Cook Children's Medical Center Fort Worth Texas Recruiting
Pediatric Specialists of Virginia Fairfax Virginia Not Yet Recruiting
Medizinische Universität Wien Vienna Austria Not Yet Recruiting
UZ Brussel Brussels Belgium Not Yet Recruiting
Cliniques universitaires Saint-Luc Brussels Belgium Not Yet Recruiting
Antwerp University Hospital Edegem Belgium Not Yet Recruiting
UZ Gent Ghent Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
Centro de Pesquisa Sao Lucas Campinas Brazil Not Yet Recruiting
Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância Curitiba Brazil Not Yet Recruiting
Universidade Federal de Goias Goiânia Brazil Not Yet Recruiting
Hospital de Clinicas de Porto Alegre Porto Alegre Brazil Not Yet Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre Porto Alegre Brazil Not Yet Recruiting
Hospital Universitario Cassiano Antonio de Moraes Vitória Brazil Not Yet Recruiting
Integral Pesquisa e Ensino Votuporanga Brazil Not Yet Recruiting
London Health Sciences Centre London Canada Not Yet Recruiting
The Hospital for Sick Children Toronto Canada Recruiting
Universitätsmedizin Johannes Gutenberg Universität Mainz Mainz Germany Recruiting
Dr. von Haunersches Kinderspital Munich Germany Recruiting
Soroka Medical Center Beersheba Israel Not Yet Recruiting
Rambam Health Care Campus Haifa Israel Not Yet Recruiting
Shaare Zedek Medical Center Jerusalem Israel Recruiting
Hadassah Medical Center Jerusalem Israel Recruiting
Schneider Children's Medical Center Petah Tikva Israel Recruiting
Yitzhak Shamir Medical Center Ẕerifin Israel Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Bergamo Italy Not Yet Recruiting
Ospedale Maggiore Azienda USL di Bologna Bologna Italy Not Yet Recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy Recruiting
Ospedale dei Bambini Vittore Buzzi Milan Italy Recruiting
AOU Policlinico Umberto I Roma Italy Recruiting
Ospedale Pediatrico Bambino Gesù IRCCS Rome Italy Not Yet Recruiting

+ 29 more sites — see the full list on the official registry below.

On this site

📄 Omvoh (mirikizumab) drug profile →

More Eli Lilly and Company trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04844606 on ClinicalTrials.gov ↗ ← All trials in Canada