Actively Recruiting
A Master Protocol for a Phase 3, Open-label, Long-term Extension Study of Mirikizumab in Children and Adolescents with Moderate-to-Severe Ulcerative Colitis or Crohn's Disease
Led by Eli Lilly and Company · Updated on 2026-06-03
150
Participants Needed
67
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term efficacy and safety of mirikizumab in children and adolescents with moderate-to-severe ulcerative colitis (UC) or Crohn's disease (CD). This Phase 3, open-label, multicenter study aims to understand how well mirikizumab works over an extended period, lasting about 172 weeks with up to 44 visits. The study is sponsored by Eli Lilly and Company and includes participants aged 2 to 19 years who have previously been treated with mirikizumab in earlier studies. Participants receive mirikizumab administered subcutaneously (under the skin), with dosing based on their weight. There are multiple doses, numbered Dose 1 through Dose 6, with an additional intravenous rescue dose available if a participant loses response to the treatment. The study follows an open-label design without randomization or masking. Throughout the study, participants undergo regular assessments including clinical remission and response measured by the Modified Mayo Score for UC and the Pediatric Crohn's Disease Activity Index for CD at Week 52. Other outcomes include endoscopic remission and response, corticosteroid-free remission, and changes in inflammatory markers. Safety is monitored continuously, and additional treatment may be offered during a continued access period. The total participation time can last over three years, with extensive follow-up visits and evaluations.
CONDITIONS
Brief 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 must have previously participated in specified originating studies and be expected to benefit from further mirikizumab treatment
- Participants must have completed last visit assessments and remain on mirikizumab treatment
- Female participants must agree to contraception requirements
You will not qualify if you...
- Participants who had serious adverse events or other conditions posing unreasonable risk from mirikizumab before the study
- Participants who permanently or temporarily stopped mirikizumab in the originating study making restart unsafe
- Participants with unstable or uncontrolled illnesses affecting safety
- Participants whose study participation would compromise safety or data interpretation
- Participants with adenomatous polyps that have not been removed
- Participants who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 52 weeks
Participants receive doses of Mirikizumab subcutaneously based on their weight. Intravenous rescue dosing may be given if response is lost.
Multiple visits for dosing and assessments during treatment
Trial Site Locations
Total: 67 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
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
10
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
11
Pediatric Specialists of Virginia
Fairfax, Virginia, United States, 22031
Not Yet Recruiting
12
Medizinische Universität Wien
Vienna, Austria, 1090
Not Yet Recruiting
13
UZ Brussel
Brussels, Belgium, 1090
Not Yet Recruiting
14
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Not Yet Recruiting
15
Antwerp University Hospital
Edegem, Belgium, 2650
Not Yet Recruiting
16
UZ Gent
Ghent, Belgium, 9000
Not Yet Recruiting
17
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
18
Centro de Pesquisa Sao Lucas
Campinas, Brazil, 13060-803
Not Yet Recruiting
19
Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância
Curitiba, Brazil, 80250-060
Not Yet Recruiting
20
Universidade Federal de Goias
Goiânia, Brazil, 74605-020
Not Yet Recruiting
21
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil, 90035-903
Not Yet Recruiting
22
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil, 90050-170
Not Yet Recruiting
23
Hospital Universitario Cassiano Antonio de Moraes
Vitória, Brazil, 29040-091
Not Yet Recruiting
24
Integral Pesquisa e Ensino
Votuporanga, Brazil, 15500-269
Not Yet Recruiting
25
London Health Sciences Centre
London, Canada, N6A 5W9
Not Yet Recruiting
26
The Hospital for Sick Children
Toronto, Canada, M5G 1X8
Actively Recruiting
27
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Germany, 55131
Actively Recruiting
28
Dr. von Haunersches Kinderspital
Munich, Germany, 80337
Actively Recruiting
29
Rambam Health Care Campus
Haifa, Israel, 3109601
Not Yet Recruiting
30
Shaare Zedek Medical Center
Jerusalem, Israel, 9013102
Actively Recruiting
31
Hadassah Medical Center
Jerusalem, Israel, 9112001
Actively Recruiting
32
Schneider Children's Medical Center
Petah Tikva, Israel, 49202
Actively Recruiting
33
Yitzhak Shamir Medical Center
Ẕerifin, Israel, 70300
Actively Recruiting
34
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Italy, 24127
Not Yet Recruiting
35
Ospedale Maggiore Azienda USL di Bologna
Bologna, Italy, 40133
Not Yet Recruiting
36
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, Italy, 50139
Actively Recruiting
37
Ospedale dei Bambini Vittore Buzzi
Milan, Italy, 20154
Actively Recruiting
38
AOU Policlinico Umberto I
Roma, Italy, 00161
Actively Recruiting
39
Ospedale Pediatrico Bambino Gesù IRCCS
Rome, Italy, 00165
Not Yet Recruiting
40
Institute of Science Tokyo Hospital
Bunkyō, Japan, 113-8519
Actively Recruiting
41
Juntendo University Hospital
Bunkyō City, Japan, 113-8431
Actively Recruiting
42
Tsujinaka Hospital - Kashiwanoha
Kashiwa, Japan, 273-0011
Actively Recruiting
43
Kobe University Hospital
Kobe, Japan, 650-0017
Not Yet Recruiting
44
National Center for Child Health and Development
Tokyo, Japan, 157-8535
Not Yet Recruiting
45
Yokohama City University Medical Center
Yokohama, Japan, 232-0024
Actively Recruiting
46
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
47
Akershus Universitetssykehus
Lørenskog, Norway, 1478
Not Yet Recruiting
48
Oslo Universitetssykehus Ullevål
Oslo, Norway, 0450
Not Yet Recruiting
49
Universitetssykehuset Nord-Norge HF
Tromsø, Norway, 9038
Not Yet Recruiting
50
St. Olavs Hospital
Trondheim, Norway, 7030
Not Yet Recruiting
51
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Poland, 35-302
Actively Recruiting
52
Twoja Przychodnia SCM
Szczecin, Poland, 71-434
Actively Recruiting
53
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Poland, 04-501
Actively Recruiting
54
Centrum Zdrowia Dziecka w Warszawie
Warsaw, Poland, 04-730
Actively Recruiting
55
Centrum Medyczne Oporów
Wroclaw, Poland, 52-416
Actively Recruiting
56
2Ca Braga
Braga, Portugal, 4710-243
Not Yet Recruiting
57
Centro Hospitalar de Sao Joao - Hospital de Sao Joao
Porto, Portugal, 4200-319
Actively Recruiting
58
Kyungpook National University Chilgok Hospital
Deagu, South Korea, 41404
Actively Recruiting
59
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
60
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
61
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Not Yet Recruiting
62
Hospital Sant Joan de Déu
Esplugues de Llobregat, Spain, 08950
Not Yet Recruiting
63
Hospital Universitari Parc Tauli
Sabadell, Spain, 08208
Not Yet Recruiting
64
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
65
Royal London Hospital
London, United Kingdom, E1 1BB
Not Yet Recruiting
66
The John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Not Yet Recruiting
67
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
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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