Actively Recruiting
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
Led by Eli Lilly and Company · Updated on 2026-05-14
150
Participants Needed
66
Research Sites
496 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants from specified prior studies who may benefit from continued mirikizumab treatment
- Participants who completed assessments and treatments in the originating study and remain on study drug
- Female participants must agree to contraception requirements
You will not qualify if you...
- Participants who developed serious adverse events or conditions posing unreasonable risk before first visit
- Participants who stopped study drug in the originating study and restarting poses unacceptable risk
- Participants with unstable or uncontrolled illnesses affecting safety
- Participants whose study participation would compromise safety or data integrity
- Participants with adenomatous polyps not removed
- Participants who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 66 locations
1
UCSF Medical Center at Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
2
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
3
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, United States, 30342
Actively Recruiting
5
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
6
Massachusetts General Hospital
Waltham, Massachusetts, United States, 02451
Actively Recruiting
7
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
9
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
10
Pediatric Specialists of Virginia
Fairfax, Virginia, United States, 22031
Not Yet Recruiting
11
Medizinische Universität Wien
Vienna, Austria, 1090
Not Yet Recruiting
12
UZ Brussel
Brussels, Belgium, 1090
Not Yet Recruiting
13
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Not Yet Recruiting
14
Antwerp University Hospital
Edegem, Belgium, 2650
Not Yet Recruiting
15
UZ Gent
Ghent, Belgium, 9000
Not Yet Recruiting
16
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
17
Centro de Pesquisa Sao Lucas
Campinas, Brazil, 13060-803
Not Yet Recruiting
18
Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância
Curitiba, Brazil, 80250-060
Not Yet Recruiting
19
Universidade Federal de Goias
Goiânia, Brazil, 74605-020
Not Yet Recruiting
20
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil, 90035-903
Not Yet Recruiting
21
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil, 90050-170
Not Yet Recruiting
22
Hospital Universitario Cassiano Antonio de Moraes
Vitória, Brazil, 29040-091
Not Yet Recruiting
23
Integral Pesquisa e Ensino
Votuporanga, Brazil, 15500-269
Not Yet Recruiting
24
London Health Sciences Centre
London, Canada, N6A 5W9
Not Yet Recruiting
25
The Hospital for Sick Children
Toronto, Canada, M5G 1X8
Actively Recruiting
26
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Germany, 55131
Actively Recruiting
27
Dr. von Haunersches Kinderspital
Munich, Germany, 80337
Actively Recruiting
28
Rambam Health Care Campus
Haifa, Israel, 3109601
Not Yet Recruiting
29
Shaare Zedek Medical Center
Jerusalem, Israel, 9013102
Actively Recruiting
30
Hadassah Medical Center
Jerusalem, Israel, 9112001
Actively Recruiting
31
Schneider Children's Medical Center
Petah Tikva, Israel, 49202
Actively Recruiting
32
Yitzhak Shamir Medical Center
Ẕerifin, Israel, 70300
Actively Recruiting
33
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Italy, 24127
Not Yet Recruiting
34
Ospedale Maggiore Azienda USL di Bologna
Bologna, Italy, 40133
Not Yet Recruiting
35
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, Italy, 50139
Actively Recruiting
36
Ospedale dei Bambini Vittore Buzzi
Milan, Italy, 20154
Actively Recruiting
37
AOU Policlinico Umberto I
Roma, Italy, 00161
Actively Recruiting
38
Ospedale Pediatrico Bambino Gesù IRCCS
Rome, Italy, 00165
Not Yet Recruiting
39
Institute of Science Tokyo Hospital
Bunkyō, Japan, 113-8519
Actively Recruiting
40
Juntendo University Hospital
Bunkyō City, Japan, 113-8431
Actively Recruiting
41
Tsujinaka Hospital - Kashiwanoha
Kashiwa, Japan, 273-0011
Actively Recruiting
42
Kobe University Hospital
Kobe, Japan, 650-0017
Not Yet Recruiting
43
National Center for Child Health and Development
Tokyo, Japan, 157-8535
Not Yet Recruiting
44
Yokohama City University Medical Center
Yokohama, Japan, 232-0024
Actively Recruiting
45
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
46
Akershus Universitetssykehus
Lørenskog, Norway, 1478
Not Yet Recruiting
47
Oslo Universitetssykehus Ullevål
Oslo, Norway, 0450
Not Yet Recruiting
48
Universitetssykehuset Nord-Norge HF
Tromsø, Norway, 9038
Not Yet Recruiting
49
St. Olavs Hospital
Trondheim, Norway, 7030
Not Yet Recruiting
50
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Poland, 35-302
Actively Recruiting
51
Twoja Przychodnia SCM
Szczecin, Poland, 71-434
Actively Recruiting
52
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Poland, 04-501
Actively Recruiting
53
Centrum Zdrowia Dziecka w Warszawie
Warsaw, Poland, 04-730
Actively Recruiting
54
Centrum Medyczne Oporów
Wroclaw, Poland, 52-416
Actively Recruiting
55
2Ca Braga
Braga, Portugal, 4710-243
Not Yet Recruiting
56
Centro Hospitalar de Sao Joao - Hospital de Sao Joao
Porto, Portugal, 4200-319
Actively Recruiting
57
Kyungpook National University Chilgok Hospital
Deagu, South Korea, 41404
Actively Recruiting
58
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
59
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
60
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Not Yet Recruiting
61
Hospital Sant Joan de Déu
Esplugues de Llobregat, Spain, 08950
Not Yet Recruiting
62
Hospital Universitari Parc Tauli
Sabadell, Spain, 08208
Not Yet Recruiting
63
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Not Yet Recruiting
64
Royal London Hospital
London, United Kingdom, E1 1BB
Not Yet Recruiting
65
The John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Not Yet Recruiting
66
Sheffield Children's Hospital
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here