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NCT04844606RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 7 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
150 (estimated)
First submitted
12 Apr 2021
Start date
26 May 2021
Primary completion date
31 Dec 2030
Lead sponsor
Eli Lilly and Company
NCT number
NCT04844606
EudraCT number
2020-005311-49

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 150
  • From 26 May 2021 to the primary completion date, 31 Dec 2030
  • 69 sites in 16 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 2 years to 19 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (69)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medizinische Universität Wien
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ViennaAustriaNot yet recruiting
UZ Brussel
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BrusselsBelgiumRecruiting
Cliniques universitaires Saint-Luc
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BrusselsBelgiumNot yet recruiting
Antwerp University Hospital
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EdegemBelgiumNot yet recruiting
UZ Gent
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GhentBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Centro de Pesquisa Sao Lucas
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CampinasBrazilNot yet recruiting
Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância
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CuritibaBrazilNot yet recruiting
Universidade Federal de Goias
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GoiâniaBrazilNot yet recruiting
Hospital de Clinicas de Porto Alegre
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Porto AlegreBrazilNot yet recruiting
Irmandade Da Santa Casa de Misericordia de Porto Alegre
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Porto AlegreBrazilNot yet recruiting
Hospital Universitário Cassiano Antônio de Moraes
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VitóriaBrazilNot yet recruiting
Integral Pesquisa e Ensino
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VotuporangaBrazilNot yet recruiting
London Health Sciences Centre
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LondonCanadaNot yet recruiting
The Hospital for Sick Children
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TorontoCanadaRecruiting
Universitätsmedizin Johannes Gutenberg Universität Mainz
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MainzGermanyRecruiting
Dr. von Haunersches Kinderspital
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MunichGermanyRecruiting
Hospital Universitario Reina Sofia
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CórdobaSpainNot yet recruiting
Hospital Sant Joan De Deu
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Esplugues de LlobregatSpainNot yet recruiting
Hospital Universitari Parc Taulí
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SabadellSpainNot yet recruiting
Hospital Universitari i Politécnic La Fe
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ValenciaSpainRecruiting
Royal London Hospital
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LondonUnited KingdomNot yet recruiting
The John Radcliffe Hospital
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OxfordUnited KingdomNot yet recruiting
Sheffield Children's Hospital
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SheffieldUnited KingdomRecruiting
Soroka Medical Center
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BeershebaIsraelNot yet recruiting
Rambam Health Care Campus
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HaifaIsraelNot yet recruiting
Shaare Zedek Medical Center
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JerusalemIsraelRecruiting
Hadassah medical Center
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JerusalemIsraelRecruiting
Schneider Children's Medical Center
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Petah TikvaIsraelRecruiting
Yitzhak Shamir Medical Center
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TsrifinIsraelRecruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyNot yet recruiting
Ospedale Maggiore Azienda USL di Bologna
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BolognaItalyNot yet recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
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FlorenceItalyRecruiting
Ospedale dei Bambini "Vittore Buzzi"
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MilanItalyRecruiting
AOU Policlinico Umberto I
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RomaItalyRecruiting
Ospedale Pediatrico Bambino Gesu Irccs
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RomeItalyNot yet recruiting
Institute of Science Tokyo Hospital
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BunkyōJapanRecruiting
Juntendo University Hospital
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Bunkyō CityJapanRecruiting
Tsujinaka Hospital Kashiwanoha
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KashiwaJapanRecruiting
Kobe University Hospital
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KobeJapanRecruiting
National Center for Child Health and Development
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TokyoJapanRecruiting
Yokohama City University Medical Center
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YokohamaJapanRecruiting
Kyungpook National University Chilgok Hospital
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DeaguSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Erasmus Medisch Centrum
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RotterdamNetherlandsNot yet recruiting
Akershus universitetssykehus
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LørenskogNorwayNot yet recruiting
Oslo Universitetssykehus Ullevål
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OsloNorwayNot yet recruiting
Universitetssykehuset Nord-Norge HF
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TromsøNorwayNot yet recruiting
St Olavs Hospital
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TrondheimNorwayNot yet recruiting
Korczowski Bartosz, Gabinet Lekarski
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RzeszówPolandRecruiting
Twoja Przychodnia SCM
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SzczecinPolandRecruiting
Centrum Zdrowia Dziecka w Warszawie
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WarsawPolandRecruiting
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
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WarsawPolandRecruiting
Centrum Medyczne Oporow
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WroclawPolandRecruiting
2Ca Braga
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BragaPortugalNot yet recruiting
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
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LisbonPortugalNot yet recruiting
Centro Hospitalar de Sao Joao - Hospital de Sao Joao
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PortoPortugalRecruiting
Emory University School of Medicine
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AtlantaUnited StatesRecruiting
Children's Center for Digestive Health Care, LLC
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AtlantaUnited StatesRecruiting
Boston Children's Hospital
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BostonUnited StatesRecruiting
Pediatric Specialists Of Virginia
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FairfaxUnited StatesNot yet recruiting
Cook Children's Medical Center
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Fort WorthUnited StatesRecruiting
Connecticut Children's Medical Center
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HartfordUnited StatesRecruiting
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesRecruiting
Children's Hospital of Philadelphia (CHOP)
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PhiladelphiaUnited StatesNot yet recruiting
UCSF Medical Center at Mission Bay
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San FranciscoUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
Massachusetts General Hospital
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WalthamUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.