Phase
Condition
Ulcerative Colitis
Crohn's Disease
Inflammatory Bowel Disease
Treatment
Guselkumab
Placebo
Clinical Study ID
Ages 2-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, withactive colitis, ileitis, or ileocolitis, confirmed at any time in the past byclinical, endoscopic, and histologic criteria.
Participants must have moderately to severely active CD (as defined by a baselinePediatric Crohn's Disease Activity Index [PCDAI] score greater than or equal to [>=]
Participants must have endoscopy with evidence of active CD defined as SimpleEndoscopic Score for Crohn's Disease (SES-CD) score greater than or equal to (>=) 6 (or >=4 for participants with isolated ileal disease) within 1 month of receivingstudy intervention at Week 0
Participants must have a history of inadequate response, loss of response, orintolerance to immunomodulators (6-MP, AZA, or MTX), oral or IV corticosteroids, orbiologic therapy/JAK inhibitor therapy; OR have a history of corticosteroiddependence; OR have a history of inadequate response to exclusive enteral nutrition (EEN)
Exclusion
Exclusion Criteria:
Participants has complications of CD such as symptomatic strictures or stenosis,short gut syndrome, or any other manifestation that might be anticipated to requiresurgery.
Participants must not have an abscess
Participants must not have any kind of bowel resection within 26 weeks or any otherintra-abdominal surgery within 12 weeks of baseline
Study Design
Connect with a study center
Perth Children's Hospital
Nedlands, 6009
AustraliaActive - Recruiting
Mater Hospital Brisbane
South Brisbane, 4101
AustraliaActive - Recruiting
The Children's Hospital at Westmead
Westmead, 2145
AustraliaActive - Recruiting
AKH - Medizinische Universitat Wien
Vienna, 1090
AustriaActive - Recruiting
AKH - Medizinische Universität Wien
Vienna, 1090
AustriaActive - Recruiting
Cliniques Universitaires Saint Luc
Brussels, 1200
BelgiumActive - Recruiting
Universitair Ziekenhuis Brussel
Brussels, 1090
BelgiumActive - Recruiting
Cliniques Universitaires Saint Luc
Brussels 2800866, 1200
BelgiumActive - Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
BelgiumActive - Recruiting
UZ Leuven
Leuven, 3000
BelgiumActive - Recruiting
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
Campinas, 13060-904
BrazilActive - Recruiting
Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro
Curitiba, 80250-060
BrazilActive - Recruiting
Universidade Federal de Goias - Hospital das Clinicas da UFG
Goiânia, 74605-020
BrazilActive - Recruiting
Hospital De Clinicas De Porto Alegre
Porto Alegre, 90035-007
BrazilActive - Recruiting
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90035-074
BrazilActive - Recruiting
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre 3452925, 90035-074
BrazilActive - Recruiting
Centro de Ciencias e Saude da Universidade Federal do Espirito Santo-Nucleo de Doencas Infecciosas
Vitória, 29040-091
BrazilActive - Recruiting
INTEGRAL Pesquisa e Ensino
Votuporanga, 100000
BrazilActive - Recruiting
Iwk Health Centre
Halifax, Nova Scotia B3K 6R8
CanadaActive - Recruiting
London Health Sciences Centre Victoria Hospital
London, Ontario N6A 5W9
CanadaActive - Recruiting
Hospital For Sick Children
Toronto, Ontario M5G 1X8
CanadaActive - Recruiting
CHU Amiens-Hopital Nord
Amiens, 80054
FranceActive - Recruiting
Hôpital Jeanne de FLANDRE, CHRU LILLE
Lille, 59037
FranceActive - Recruiting
Hôpital Necker - Enfants Malades
Paris, 75015
FranceActive - Recruiting
Hôpital Robert Debré
Paris, 75019
FranceActive - Recruiting
Hôpital Necker - Enfants Malades
Paris 2988507, 75015
FranceActive - Recruiting
Soroka University Medical Center
Beersheba, 84101
IsraelActive - Recruiting
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov, 70300
IsraelActive - Recruiting
Hadassah Medical Center
Jerusalem, 9124001
IsraelActive - Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
IsraelActive - Recruiting
Shaare Zedek Medical Center
Jerusalem 281184, 9103102
IsraelActive - Recruiting
Schneider Children's Medical Center
Petah Tikva, 4920235
IsraelActive - Recruiting
Kaplan Medical Center
Rehovot, 761001
IsraelActive - Recruiting
A.O. Santi Antonio e Biagio e Cesare Arrigo
Alessandria, 15121
ItalyActive - Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, 24127
ItalyActive - Recruiting
Ospedale Bellaria, U.O.Cardiologia Az. USL di Bologna
Bologna, 40124
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
Florence, 50139
ItalyActive - Recruiting
Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale dei Bambini Vittore Buzzi
Milan, 20154
ItalyActive - Recruiting
AOU Policlinico Umberto I
Roma, 161
ItalyActive - Recruiting
Hirosaki University Hospital
Hirosaki, 036-8563
JapanActive - Recruiting
Kagoshima University Hospital
Kagoshima, 890-8544
JapanActive - Recruiting
Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, 277-0871
JapanActive - Recruiting
Kobe University Hospital
Kobe, 650 0017
JapanActive - Recruiting
Saga University Hospital
Saga, 849-8501
JapanActive - Recruiting
Miyagi Children's Hospital
Sendai, 989-3126
JapanActive - Recruiting
Miyagi Childrens Hospital
Sendai, 989-3126
JapanActive - Recruiting
National Center for Child Health and Development
Setagaya Ku, 157 8535
JapanActive - Recruiting
Juntendo University Hospital
Tokyo, 113-8431
JapanActive - Recruiting
Mie University Hospital
Tsu, 514 8507
JapanActive - Recruiting
Yamaguchi University Hospital
Ube, 755-8505
JapanActive - Recruiting
Saiseikai Yokohamashi Tobu Hospital
Yokohama, 230-8765
JapanActive - Recruiting
Yokohama City University Medical Center
Yokohama, 232-0024
JapanActive - Recruiting
Yokohama City University Medical Center
Yokohama 1848354, 232-0024
JapanActive - Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 120-752
Korea, Republic ofSite Not Available
Erasmus Medisch Centrum
Rotterdam, 3015 GD
NetherlandsActive - Recruiting
Akershus Universitetssykehus HF
Nordbyhagen, 1474
NorwayActive - Recruiting
Oslo University Hospital
Oslo, 424
NorwayActive - Recruiting
Universitetssykehuset Nord-Norge HF
Tromsø, 9038
NorwayActive - Recruiting
St. Olavs Hospital
Trondheim, 7030
NorwayActive - Recruiting
Korczowski Bartosz Gabinet Lekarski
Rzeszów, 35-302
PolandActive - Recruiting
Instytut Pomnik Centrum Zdrowia
Warsaw, 04 730
PolandActive - Recruiting
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04 501
PolandActive - Recruiting
Instytut Pomnik Centrum Zdrowia
Warsaw 756135, 04 730
PolandActive - Recruiting
Centrum Zdrowia MDM
Warszawa, 00-635
PolandActive - Recruiting
WIP Warsaw IBD Point Profesor Kierkus
Warszawa, 04 501
PolandActive - Recruiting
Hospital de Braga
Braga, 4710-243
PortugalActive - Recruiting
Centro Hospitalar de Lisboa Norte Hospital Santa Maria
Lisbon, 1649-035
PortugalActive - Recruiting
Centro Hospitalar de Sao Joao E.P.E.
Porto, 4200-319
PortugalActive - Recruiting
Inje University Haeundae Paik Hospital
Busan, 48108
South KoreaActive - Recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
South KoreaActive - Recruiting
Samsung Medical Center
Seoul, 06351
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul, 03080
South KoreaActive - Recruiting
Severance Hospital Yonsei University Health System
Seoul, 120-752
South KoreaActive - Recruiting
Samsung Medical Center
Seoul 1835848, 06351
South KoreaActive - Recruiting
Severance Hospital Yonsei University Health System
Seoul 1835848, 120-752
South KoreaActive - Recruiting
Hosp Reina Sofia
Córdoba, 14004
SpainActive - Recruiting
Hosp. Infantil Univ. Niño Jesus
Madrid, 28009
SpainSite Not Available
Corporacio Sanitari Parc Tauli
Sabadell, 8208
SpainActive - Recruiting
Hosp. Univ. I Politecni La Fe
Valencia, 46026
SpainActive - Recruiting
Royal Hospital for Sick Children
Glasgow, G51 4TF
United KingdomActive - Recruiting
Great Ormond Street Hospital
London, WC1N 3JH
United KingdomActive - Recruiting
Nowgen Centre, Research and Innovation
Manchester, M13 9WL
United KingdomActive - Recruiting
Royal Manchester Children's Hospital
Manchester, M13 9WL
United KingdomActive - Recruiting
Royal Manchester Children's Hospital
Manchester 2643123, M13 9WL
United KingdomActive - Recruiting
John Radcliffe Hospital
Oxford, OX3 9DU
United KingdomActive - Recruiting
Sheffield Children's Hospital
Sheffield, S10 2TH
United KingdomActive - Recruiting
Cedars Sinai Medical Center
Los Angeles, California 90048
United StatesActive - Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut 06106
United StatesActive - Recruiting
Children's Center for Digestive Health Care
Atlanta, Georgia 30342
United StatesActive - Recruiting
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Children's Center for Digestive Health Care
Atlanta 4180439, Georgia 4197000 30342
United StatesActive - Recruiting
Riley Hospital for Children
Indianapolis, Indiana 46202-5225
United StatesActive - Recruiting
Boston Childrens Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Goryeb Children's Hospital
Morristown, New Jersey 07960
United StatesActive - Recruiting
Columbia University Medical Center
New York, New York 10032
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center
New York, New York 10021-5663
United StatesActive - Recruiting
Columbia University Medical Center
New York 5128581, New York 5128638 10032
United StatesActive - Recruiting
Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center
New York 5128581, New York 5128638 10021-5663
United StatesActive - Recruiting
The Children's Medical Center of Dayton
Dayton, Ohio 45404
United StatesActive - Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Cook Childrens Medical Center
Fort Worth, Texas 76104
United StatesActive - Recruiting
University of Vermont Medical Center
Colchester, Vermont 05446
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.