RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT04844606

Registry updated: 2026-10-07

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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.

Interventions

Mirikizumab (Drug)
Administered SC
Mirikizumab (Drug)
Administered IV

Eligibility criteria

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.

Conditions

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

Locations

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
Washington University School of Medicine — St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
Children's Hospital of Philadelphia (CHOP) — Philadelphia, Pennsylvania, United States
Cook Children's Medical Center — Fort Worth, Texas, United States
Pediatric Specialists of Virginia — Fairfax, Virginia, United States
Medizinische Universität Wien — Vienna, Austria
UZ Brussel — Brussels, Belgium
Cliniques universitaires Saint-Luc — Brussels, Belgium
Antwerp University Hospital — Edegem, Belgium
UZ Gent — Ghent, Belgium
UZ Leuven — Leuven, Belgium
Centro de Pesquisa Sao Lucas — Campinas, Brazil
Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância — Curitiba, Brazil
Universidade Federal de Goias — Goiânia, Brazil
Hospital de Clinicas de Porto Alegre — Porto Alegre, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre — Porto Alegre, Brazil
Hospital Universitario Cassiano Antonio de Moraes — Vitória, Brazil
Integral Pesquisa e Ensino — Votuporanga, Brazil
London Health Sciences Centre — London, Canada
The Hospital for Sick Children — Toronto, Canada
Universitätsmedizin Johannes Gutenberg Universität Mainz — Mainz, Germany
Dr. von Haunersches Kinderspital — Munich, Germany
Soroka Medical Center — Beersheba, Israel
Rambam Health Care Campus — Haifa, Israel
Shaare Zedek Medical Center — Jerusalem, Israel
Hadassah Medical Center — Jerusalem, Israel
Schneider Children's Medical Center — Petah Tikva, Israel
Yitzhak Shamir Medical Center — Ẕerifin, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII — Bergamo, Italy
Ospedale Maggiore Azienda USL di Bologna — Bologna, Italy
Azienda Ospedaliera Universitaria Meyer IRCCS — Florence, Italy
Ospedale dei Bambini Vittore Buzzi — Milan, Italy
AOU Policlinico Umberto I — Roma, Italy
Ospedale Pediatrico Bambino Gesù IRCCS — Rome, Italy
Institute of Science Tokyo Hospital — Bunkyō, Japan
Juntendo University Hospital — Bunkyō City, Japan
Tsujinaka Hospital - Kashiwanoha — Kashiwa, Japan
Kobe University Hospital — Kobe, Japan
National Center for Child Health and Development — Tokyo, Japan
Yokohama City University Medical Center — Yokohama, Japan
Erasmus Medisch Centrum — Rotterdam, Netherlands
Akershus Universitetssykehus — Lørenskog, Norway
Oslo Universitetssykehus Ullevål — Oslo, Norway
Universitetssykehuset Nord-Norge HF — Tromsø, Norway
St. Olavs Hospital — Trondheim, Norway
Korczowski Bartosz, Gabinet Lekarski — Rzeszów, Poland
Twoja Przychodnia SCM — Szczecin, Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś — Warsaw, Poland
Centrum Zdrowia Dziecka w Warszawie — Warsaw, Poland
Centrum Medyczne Oporów — Wroclaw, Poland
2Ca Braga — Braga, Portugal
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria — Lisbon, Portugal
Centro Hospitalar de Sao Joao - Hospital de Sao Joao — Porto, Portugal
Kyungpook National University Chilgok Hospital — Deagu, South Korea
Seoul National University Hospital — Seoul, South Korea
Samsung Medical Center — Seoul, South Korea
Hospital Universitario Reina Sofia — Córdoba, Spain
Hospital Sant Joan de Déu — Esplugues de Llobregat, Spain
Hospital Universitari Parc Tauli — Sabadell, Spain
Hospital Universitari i Politecnic La Fe — Valencia, Spain
Royal London Hospital — London, United Kingdom
The John Radcliffe Hospital — Oxford, United Kingdom
Sheffield Children's Hospital — Sheffield, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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