Actively Recruiting
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
120
Participants Needed
85
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.
CONDITIONS
Official Title
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD with active colitis, ileitis, or ileocolitis confirmed by clinical, endoscopic, and histologic criteria
- Participants must have moderately to severely active CD with a Pediatric Crohn's Disease Activity Index (PCDAI) score of 30 or higher
- Participants must have endoscopy evidence of active CD with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of 6 or higher, or 4 or higher if isolated ileal disease, within 1 month before starting study treatment
- Participants must have a history of inadequate response, loss of response, or intolerance to immunomodulators (6-MP, AZA, or MTX), corticosteroids, biologic therapy/JAK inhibitors; OR corticosteroid dependence; OR inadequate response to exclusive enteral nutrition
You will not qualify if you...
- Participants with complications such as symptomatic strictures or stenosis, short gut syndrome, or other conditions expected to require surgery
- Participants with an abscess
- Participants who had bowel resection surgery within 26 weeks or other intra-abdominal surgery within 12 weeks before the study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 85 locations
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
3
Emory University
Atlanta, Georgia, United States, 30322
Active, Not Recruiting
4
Children's Center for Digestive Health Care
Atlanta, Georgia, United States, 30342
Actively Recruiting
5
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202-5225
Actively Recruiting
6
Boston Childrens Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
7
Goryeb Children's Hospital
Morristown, New Jersey, United States, 07960
Actively Recruiting
8
Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center
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, New York, United States, 10032
Actively Recruiting
11
The Children's Medical Center of Dayton
Dayton, Ohio, United States, 45404
Actively Recruiting
12
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
13
Cook Childrens Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
14
University of Vermont Medical Center
Colchester, Vermont, United States, 05446
Actively Recruiting
15
Perth Children's Hospital
Nedlands, Australia, 6009
Actively Recruiting
16
Mater Hospital Brisbane
South Brisbane, Australia, 4101
Actively Recruiting
17
The Children's Hospital at Westmead
Westmead, Australia, 2145
Actively Recruiting
18
AKH - Medizinische Universitat Wien
Vienna, Austria, 1090
Actively Recruiting
19
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
Actively Recruiting
20
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Actively Recruiting
21
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
22
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
23
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
Campinas, Brazil, 13060-904
Actively Recruiting
24
Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro
Curitiba, Brazil, 80250-060
Actively Recruiting
25
Universidade Federal de Goias - Hospital das Clinicas da UFG
Goiânia, Brazil, 74605-020
Actively Recruiting
26
Hospital De Clinicas De Porto Alegre
Porto Alegre, Brazil, 90035-007
Actively Recruiting
27
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil, 90035-074
Actively Recruiting
28
Centro de Ciencias e Saude da Universidade Federal do Espirito Santo-Nucleo de Doencas Infecciosas
Vitória, Brazil, 29040-091
Actively Recruiting
29
INTEGRAL Pesquisa e Ensino
Votuporanga, Brazil, 100000
Actively Recruiting
30
Iwk Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
31
London Health Sciences Centre Victoria Hospital
London, Ontario, Canada, N6A 5W9
Actively Recruiting
32
Hospital For Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
33
CHU Amiens-Hopital Nord
Amiens, France, 80054
Actively Recruiting
34
Hôpital Jeanne de FLANDRE, CHRU LILLE
Lille, France, 59037
Actively Recruiting
35
Hôpital Necker - Enfants Malades
Paris, France, 75015
Actively Recruiting
36
Hôpital Robert Debré
Paris, France, 75019
Actively Recruiting
37
Soroka University Medical Center
Beersheba, Israel, 84101
Actively Recruiting
38
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov, Israel, 70300
Actively Recruiting
39
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
40
Hadassah Medical Center
Jerusalem, Israel, 9124001
Actively Recruiting
41
Schneider Children's Medical Center
Petah Tikva, Israel, 4920235
Actively Recruiting
42
Kaplan Medical Center
Rehovot, Israel, 761001
Actively Recruiting
43
A.O. Santi Antonio e Biagio e Cesare Arrigo
Alessandria, Italy, 15121
Actively Recruiting
44
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, Italy, 24127
Actively Recruiting
45
Ospedale Bellaria, U.O.Cardiologia Az. USL di Bologna
Bologna, Italy, 40124
Actively Recruiting
46
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
Florence, Italy, 50139
Actively Recruiting
47
Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale dei Bambini Vittore Buzzi
Milan, Italy, 20154
Actively Recruiting
48
AOU Policlinico Umberto I
Roma, Italy, 161
Actively Recruiting
49
Hirosaki University Hospital
Hirosaki, Japan, 036-8563
Actively Recruiting
50
Kagoshima University Hospital
Kagoshima, Japan, 890-8544
Actively Recruiting
51
Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Japan, 277-0871
Actively Recruiting
52
Kobe University Hospital
Kobe, Japan, 650 0017
Actively Recruiting
53
Saga University Hospital
Saga, Japan, 849-8501
Actively Recruiting
54
Miyagi Children's Hospital
Sendai, Japan, 989-3126
Actively Recruiting
55
National Center for Child Health and Development
Setagaya Ku, Japan, 157 8535
Actively Recruiting
56
Juntendo University Hospital
Tokyo, Japan, 113-8431
Actively Recruiting
57
Mie University Hospital
Tsu, Japan, 514 8507
Actively Recruiting
58
Yamaguchi University Hospital
Ube, Japan, 755-8505
Actively Recruiting
59
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Japan, 230-8765
Actively Recruiting
60
Yokohama City University Medical Center
Yokohama, Japan, 232-0024
Actively Recruiting
61
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
62
Akershus Universitetssykehus HF
Nordbyhagen, Norway, 1474
Actively Recruiting
63
Oslo University Hospital
Oslo, Norway, 424
Actively Recruiting
64
Universitetssykehuset Nord-Norge HF
Tromsø, Norway, 9038
Actively Recruiting
65
St. Olavs Hospital
Trondheim, Norway, 7030
Actively Recruiting
66
Korczowski Bartosz Gabinet Lekarski
Rzeszów, Poland, 35-302
Actively Recruiting
67
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Poland, 04 501
Actively Recruiting
68
Instytut Pomnik Centrum Zdrowia
Warsaw, Poland, 04 730
Actively Recruiting
69
Hospital de Braga
Braga, Portugal, 4710-243
Actively Recruiting
70
Centro Hospitalar de Lisboa Norte Hospital Santa Maria
Lisbon, Portugal, 1649-035
Actively Recruiting
71
Centro Hospitalar de Sao Joao E.P.E.
Porto, Portugal, 4200-319
Actively Recruiting
72
Inje University Haeundae Paik Hospital
Busan, South Korea, 48108
Actively Recruiting
73
Kyungpook National University Chilgok Hospital
Daegu, South Korea, 41404
Actively Recruiting
74
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
75
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
76
Severance Hospital Yonsei University Health System
Seoul, South Korea, 120-752
Actively Recruiting
77
Hosp Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
78
Corporacio Sanitari Parc Tauli
Sabadell, Spain, 8208
Actively Recruiting
79
Hosp. Univ. I Politecni La Fe
Valencia, Spain, 46026
Actively Recruiting
80
Royal Hospital for Sick Children
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
81
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Actively Recruiting
82
Nowgen Centre, Research and Innovation
Manchester, United Kingdom, M13 9WL
Actively Recruiting
83
Royal Manchester Children's Hospital
Manchester, United Kingdom, M13 9WL
Actively Recruiting
84
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
85
Sheffield Children's Hospital
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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