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
- Diseases
- Crohn's disease, Ulcerative colitis
- 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
Sites (69)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universität Wien Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| UZ Brussel Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Not yet recruiting |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Not yet recruiting |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Centro de Pesquisa Sao Lucas Coordinator of this site? Confirm its status | Campinas | Brazil | Not yet recruiting |
| Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância Coordinator of this site? Confirm its status | Curitiba | Brazil | Not yet recruiting |
| Universidade Federal de Goias Coordinator of this site? Confirm its status | Goiânia | Brazil | Not yet recruiting |
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Not yet recruiting |
| Irmandade Da Santa Casa de Misericordia de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Not yet recruiting |
| Hospital Universitário Cassiano Antônio de Moraes Coordinator of this site? Confirm its status | Vitória | Brazil | Not yet recruiting |
| Integral Pesquisa e Ensino Coordinator of this site? Confirm its status | Votuporanga | Brazil | Not yet recruiting |
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Not yet recruiting |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Universitätsmedizin Johannes Gutenberg Universität Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Dr. von Haunersches Kinderspital Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Not yet recruiting |
| Hospital Sant Joan De Deu Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Not yet recruiting |
| Hospital Universitari Parc Taulí Coordinator of this site? Confirm its status | Sabadell | Spain | Not yet recruiting |
| Hospital Universitari i Politécnic La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Royal London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| The John Radcliffe Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Not yet recruiting |
| Sheffield Children's Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Soroka Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Not yet recruiting |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Not yet recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Schneider Children's Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Yitzhak Shamir Medical Center Coordinator of this site? Confirm its status | Tsrifin | Israel | Recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Not yet recruiting |
| Ospedale Maggiore Azienda USL di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Ospedale dei Bambini "Vittore Buzzi" Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| AOU Policlinico Umberto I Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Ospedale Pediatrico Bambino Gesu Irccs Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Institute of Science Tokyo Hospital Coordinator of this site? Confirm its status | Bunkyō | Japan | Recruiting |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Recruiting |
| Tsujinaka Hospital Kashiwanoha Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
| Kobe University Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Recruiting |
| National Center for Child Health and Development Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Yokohama City University Medical Center Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Deagu | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Erasmus Medisch Centrum Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
| Akershus universitetssykehus Coordinator of this site? Confirm its status | Lørenskog | Norway | Not yet recruiting |
| Oslo Universitetssykehus Ullevål Coordinator of this site? Confirm its status | Oslo | Norway | Not yet recruiting |
| Universitetssykehuset Nord-Norge HF Coordinator of this site? Confirm its status | Tromsø | Norway | Not yet recruiting |
| St Olavs Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Not yet recruiting |
| Korczowski Bartosz, Gabinet Lekarski Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
| Twoja Przychodnia SCM Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| Centrum Zdrowia Dziecka w Warszawie Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Centrum Medyczne Oporow Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| 2Ca Braga Coordinator of this site? Confirm its status | Braga | Portugal | Not yet recruiting |
| Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria Coordinator of this site? Confirm its status | Lisbon | Portugal | Not yet recruiting |
| Centro Hospitalar de Sao Joao - Hospital de Sao Joao Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Emory University School of Medicine Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Children's Center for Digestive Health Care, LLC Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Pediatric Specialists Of Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Not yet recruiting |
| Cook Children's Medical Center Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Connecticut Children's Medical Center Coordinator of this site? Confirm its status | Hartford | United States | Recruiting |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Children's Hospital of Philadelphia (CHOP) Coordinator of this site? Confirm its status | Philadelphia | United States | Not yet recruiting |
| UCSF Medical Center at Mission Bay Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Waltham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.