Clinical trialNCT04844606RecruitingPhase 3Interventional

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

SponsorEli Lilly and CompanyEnrollment150Crohn's DiseaseInflammatory Bowel DiseasesUlcerative ColitisUlcerative Colitis Chronic

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

68 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Austria

Medizinische Universität Wien
Vienna, Austria
Wolf-Dietrich Huber
Not, yet, recruiting

Belgium

Cliniques Universitaires Saint-Luc
Brussels, Belgium
Isabelle Scheers
Not, yet, recruiting
Uz Brussel
Brussels, Belgium
Elisabeth De Greef
Not, yet, recruiting
Antwerp University Hospital
Edegem, Belgium
Els Van de Vijver
Not, yet, recruiting
Uz Gent
Ghent, Belgium
Pauline De Bruyne
Recruiting
Uz Leuven
Leuven, Belgium
Ilse Hoffman
Recruiting

Brazil

Centro de Pesquisa Sao Lucas
Campinas, Brazil
Joaquim Simoes Neto
Not, yet, recruiting
Hospital Pequeno Príncipe / Associação Hospitalar de Proteção À Infância
Curitiba, Brazil
Sabine Truppel
Not, yet, recruiting
Universidade Federal de Goias
Goiânia, Brazil
Naflesia O. Correa
Not, yet, recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
Luciana Harlacher
Not, yet, recruiting
Irmandade Da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil
Vanessa Scheffer
Not, yet, recruiting
Hospital Universitario Cassiano Antonio de Moraes
Vitória, Brazil
Ana Daniela Sadovsky
Not, yet, recruiting
Integral Pesquisa E Ensino
Votuporanga, Brazil
HERLON VALÉRIO
Not, yet, recruiting

Canada

London Health Sciences Centre
London, Canada
Dhandapani Ashok
Not, yet, recruiting
the Hospital for Sick Children
Toronto, Canada
Thomas Walters
Recruiting

Germany

Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Germany
Stephan Gehring
Recruiting
Dr. Von Haunersches Kinderspital
Munich, Germany
Tobias Schwerd
Recruiting

Israel

Soroka Medical Center
Beersheba, Israel
Gadi Howard
Not, yet, recruiting
Rambam Health Care Campus
Haifa, Israel
Ramit Magen Rimon
Not, yet, recruiting
Hadassah Medical Center
Jerusalem, Israel
Zev Davidovics
Recruiting
Shaare Zedek Medical Center
Jerusalem, Israel
Dan Turner
Recruiting
Schneider Children'S Medical Center
Petah Tikva, Israel
Dror Shouval
Recruiting
Yitzhak Shamir Medical Center
Ẕerifin, Israel
EFRAT BROIDE
Recruiting

Italy

Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Bergamo, Italy
Naire Sansotta
Not, yet, recruiting
Ospedale Maggiore Azienda Usl Di Bologna
Bologna, Italy
Patrizia Alvisi
Not, yet, recruiting
Azienda Ospedaliera Universitaria Meyer Irccs
Florence, Italy
Paolo Lionetti
Recruiting
Ospedale Dei Bambini Vittore Buzzi
Milan, Italy
Lorenzo Norsa
Recruiting
Aou Policlinico Umberto I
Roma, Italy
Salvatore Oliva
Recruiting
Ospedale Pediatrico Bambino Gesù Irccs
Rome, Italy
Fiammetta Bracci
Not, yet, recruiting

Japan

Institute of Science Tokyo Hospital
Bunkyō, Japan
Masakazu Nagahori
Recruiting
Juntendo University Hospital
Bunkyō City, Japan
Takahiro Kudo
Recruiting
Tsujinaka Hospital - Kashiwanoha
Kashiwa, Japan
Ken Takeuchi
Recruiting
Kobe University Hospital
Kobe, Japan
Tomoko Horinouchi
Not, yet, recruiting
National Center for Child Health and Development
Tokyo, Japan
Katsuhiro Arai
Recruiting
Yokohama City University Medical Center
Yokohama, Japan
Reiko Kunisaki
Recruiting

Netherlands

Erasmus Medisch Centrum
Rotterdam, Netherlands
Lissy De Ridder
Not, yet, recruiting

Norway

Akershus Universitetssykehus
Lørenskog, Norway
Christopher Inchley
Not, yet, recruiting
Oslo Universitetssykehus Ullevål
Oslo, Norway
Gori Perminow
Not, yet, recruiting
Universitetssykehuset Nord-Norge Hf
Tromsø, Norway
Lene Nymo Trulsen
Not, yet, recruiting
St. Olavs Hospital
Trondheim, Norway
Henrik Døllner
Not, yet, recruiting

28 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Mirikizumab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 26 May 2021
Primary completion: 31 Dec 2030
Completion: 31 Dec 2030
Last update posted: 7 Aug 2026
Registered enrollment: 150
Registry id: NCT04844606

Cross-registrations

EU-CTR / CTIS (EudraCT)2020-005311-49

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.