Actively Recruiting
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
Led by Eli Lilly and Company · Updated on 2026-03-27
90
Participants Needed
81
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease. Study periods for the intervention-specific appendix (ISA) will be as follows: * A 12-week induction period * A maintenance period from Week 12 to Week 52, and * A safety follow-up period up to 16 weeks. The study will last about 74 weeks and may include up to 19 visits.
CONDITIONS
Official Title
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Crohn's disease or fistulizing Crohn's disease with active colitis, ileitis, or ileocolitis confirmed by clinical, endoscopic, and histologic criteria
- Moderately to severely active Crohn's disease with a baseline Pediatric Crohn's Disease Activity Index (PCDAI) score of 30 or higher
- Endoscopy within 1 month before starting study treatment showing active disease with a Simple Endoscopic Score for Crohn's Disease (SES-CD) of 6 or more, or 4 or more for isolated ileal disease
- History of inadequate response, loss of response, or intolerance to at least one Crohn's disease medication such as immunomodulators, corticosteroids, biologics, or JAK inhibitors
You will not qualify if you...
- Presence of Crohn's disease complications like symptomatic strictures, stenosis, short gut syndrome, or other conditions likely to require surgery
- Presence of an abscess
- Bowel resection surgery within 26 weeks before baseline or any intra-abdominal surgery within 12 weeks before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 81 locations
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Not Yet Recruiting
2
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06032
Actively Recruiting
3
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, United States, 30342
Actively Recruiting
5
Riley Childrens Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
6
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
7
Atlantic Children's Health--Pediatric Gastroenterology
Morristown, New Jersey, United States, 07960
Not Yet Recruiting
8
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
New York, New York, United States, 10021-5663
Actively Recruiting
9
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
10
Columbia University Medical Center/New York Presbyterian
New York, New York, United States, 10032
Actively Recruiting
11
Childrens Medical Center
Dayton, Ohio, United States, 45404
Actively Recruiting
12
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19146
Actively Recruiting
13
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
14
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
15
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Not Yet Recruiting
16
AKH - Medizinische Universtität Wien
Vienna, Austria, 1090
Actively Recruiting
17
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
Actively Recruiting
18
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
19
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
20
UZ Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
21
Hospital PUC-CAMPINAS
Campinas, Brazil, 13060-904
Actively Recruiting
22
Hospital Pequeno Príncipe
Curitiba-PR, Brazil, 80250-060
Actively Recruiting
23
Hospital das Clínicas - UFG (Universidade Federal de Goiás)
Goiânia, Brazil, 74605-050
Actively Recruiting
24
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil, 90035-903
Actively Recruiting
25
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil, 90050-170
Actively Recruiting
26
NDI - Nucleo de Doenças Infecciosas
Santos Dumont, Brazil, 29040-091
Actively Recruiting
27
Integral Pesquisa e Ensino
Votuporanga, Brazil, 15501 405
Actively Recruiting
28
IWK Health Centre
Halifax, Canada, B3K 6R8
Not Yet Recruiting
29
London Health Sciences Centre (LHSC) - Victoria Hospital
London, Canada, N6A 5W9
Not Yet Recruiting
30
The Hospital for Sick Children
Toronto, Canada, M5G 1X8
Not Yet Recruiting
31
Children's & Women's Health Centre of British Columbia
Vancouver, Canada, V6H 3V4
Not Yet Recruiting
32
URC CIC
Paris, France, 75015
Terminated
33
Soroka Medical Center
Beersheba, Israel, 8410101
Actively Recruiting
34
Shamir Medical Center (Assaf Harofeh)
Israel, Israel, 70300
Actively Recruiting
35
Shaare Zedek
Jerusalem, Israel, 9103102
Actively Recruiting
36
Hadassah University Hospital, Ein Kerem,
Jerusalem, Israel, 9112001
Actively Recruiting
37
Schneider Children's Medical Center
Petah Tikva, Israel, 4920235
Actively Recruiting
38
Kaplan Medical Center, Pediatric Gastroenterology Dept.
Rehovot, Israel, 7661041
Not Yet Recruiting
39
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e C. Arrigo
Alessandria, Italy, 15121
Not Yet Recruiting
40
Asst Papa Giovanni Xxiii Bergamo
Bergamo, Italy, 24127
Actively Recruiting
41
Azienda USL di Bologna
Bologna, Italy, 40133
Actively Recruiting
42
SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato)
Florence, Italy, 50139
Actively Recruiting
43
Ospedale dei Bambini Vittore Buzzi
Milan, Italy, 20154
Actively Recruiting
44
Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica)
Roma, Italy, CAP 00161
Actively Recruiting
45
Juntendo University Hospital
Bunkyō City, Japan, 113-8431
Actively Recruiting
46
Hirosaki University Hospital
Hirosaki, Japan, 036
Actively Recruiting
47
Kagoshima University Hospital
Kagoshima, Japan, 890-8520
Not Yet Recruiting
48
Kokikai Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Japan, 277-0871
Actively Recruiting
49
Kobe University Hospital
Kobe, Japan, 650-0017
Not Yet Recruiting
50
Saga University Hospital
Saga, Japan, 849-8501
Actively Recruiting
51
Miyagi Children's Hospital
Sendai, Japan, 989 3126
Actively Recruiting
52
National Center for Child Health and Development
Setagaya-ku, Japan, 157-8535
Actively Recruiting
53
Mie University Hospital
Tsu, Japan, 514-8507
Not Yet Recruiting
54
Yamaguchi University Hospital
Ube, Japan, 755-8505
Not Yet Recruiting
55
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Japan, 2308765
Not Yet Recruiting
56
Yokohama City University Medical Center, Center of IBD
Yokohama, Japan, 232-0024
Actively Recruiting
57
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 CN
Actively Recruiting
58
Akershus Universitetssykehus
Nordbyagen, Norway, 01474
Actively Recruiting
59
Oslo University Hospital
Oslo, Norway, 0450
Actively Recruiting
60
Universitetssykehuset Nord-Norge
Tromsø, Norway, 9038
Actively Recruiting
61
St-Olavs Hospital
Trondheim, Norway, 7030
Actively Recruiting
62
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Poland, 35-302
Actively Recruiting
63
Warsaw IBD Point Profesor Kierkus
Warsaw, Poland, 00-728
Actively Recruiting
64
Instytut Pomnik-Centrum Zdrowia Dziecka
Warsaw, Poland, 04-730
Actively Recruiting
65
Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
Braga, Portugal, 4710-243
Actively Recruiting
66
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, Portugal, 1649-035
Actively Recruiting
67
Centro Hospitalar de São João, E.P.E.
Porto, Portugal, 4200 319
Actively Recruiting
68
Inje University Haeundae Paik Hospital
Busan, South Korea, 48108
Actively Recruiting
69
Kyungpook National University Chilgok Hospital
Daegu, South Korea, 41404
Actively Recruiting
70
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
71
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
72
Seoul National University Hospital
Seoul, South Korea, 3080
Actively Recruiting
73
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
74
Corporacio Sanitaria Parc Tauli
Sabadell, Spain, 08208
Actively Recruiting
75
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
76
Royal Hospital for Children and Young People
Edinburgh, United Kingdom, EH16 4TJ
Actively Recruiting
77
Oxford University Hospitals NHS trust John Radcliffe hospital
Headington, United Kingdom, OX3 9DU
Actively Recruiting
78
Great Ormond Street Hospital For Children NHS Foundation Trust
London, United Kingdom, WC1N 3JH
Actively Recruiting
79
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M139WL
Actively Recruiting
80
Sheffield Children's Hospital
Sheffield, United Kingdom, S10 2RX
Actively Recruiting
81
Royal London Hospital
Whitechapel, United Kingdom, E1 1FR
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
3
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