Phase
Condition
Ulcerative Colitis
Colic
Bowel Dysfunction
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 prior or current CD medication history that includes eitherinadequate response, loss of response to or failure to tolerate current treatmentimmunomodulators or with oral or intravenously (IV) corticosteroids or have receivedbiologic therapy/JAK inhibitor for the treatment of CD and have a documented historyof inadequate response, loss of response (LOR), or intolerance to the biologictherapy/JAK inhibitor
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
AustraliaSite Not Available
Women's and Children's Hospital
North Adelaide, 5006
AustraliaSite Not Available
Mater Hospital Brisbane
South Brisbane, 4101
AustraliaSite Not Available
AKH - Medizinische Universitat Wien
Vienna, 1090
AustriaActive - Recruiting
AKH - Medizinische Universität Wien
Vienna, 1090
AustriaActive - Recruiting
Cliniques Universitaires Saint-Luc
Brussel, 1200
BelgiumSite Not Available
Universitair Ziekenhuis Brussel
Brussels, 1090
BelgiumActive - Recruiting
Cliniques Universitaires Saint Luc
Bruxelles, 1200
BelgiumActive - Recruiting
Universitair Ziekenhuis Gent
Gent, 9000
BelgiumActive - Recruiting
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro
Campinas, 13060-904
BrazilSite Not Available
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, 80.250-060
BrazilActive - Recruiting
Universidade Federal de Goias - Hospital das Clinicas da UFG
Goiania, 74605-020
BrazilActive - Recruiting
Universidade Federal de Goias - Hospital das Clinicas da UFG
Goiânia, 74605-020
BrazilSite Not Available
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90035-074
BrazilActive - Recruiting
Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
Ribeirao Preto, 14098-900
BrazilSite Not Available
Centro de Ciências e Saúde da Universidade Federal do Espirito Santo-Núcleo de Doenças Infecciosas
Vitória, 29040-091
BrazilActive - Recruiting
INTEGRAL Pesquisa e Ensino
Votuporanga, 100000
BrazilActive - Recruiting
British Columbia Children's Hospital
Vancouver, British Columbia V6H 3N1
CanadaSite Not Available
Iwk Health Centre
Halifax, Nova Scotia B3K 6R8
CanadaSite Not Available
London Health Sciences Centre - Victoria Hospital
London, Ontario N6A 5W9
CanadaSite Not Available
Hospital For Sick Children
Toronto, Ontario M5G 1X8
CanadaSite Not Available
Fakultni nemocnice v Motole
Praha 5, 150 06
CzechiaSite Not Available
CHU Amiens-Hopital Nord
Amiens Cedex 1, 80054
FranceActive - Recruiting
Hôpital Jeanne de FLANDRE, CHRU LILLE
Lille, 59037
FranceActive - Recruiting
Hôpital Robert Debré
Paris, 75019
FranceActive - Recruiting
Hôpital Necker - Enfants Malades
Paris cedex 15, 75015
FranceActive - Recruiting
Shamir Medical Center Assaf Harofeh
Be Er Ya Akov, 70300
IsraelActive - Recruiting
Shamir Medical Center (Assaf Harofeh)
Be'er Ya'akov, 70300
IsraelSite Not Available
Soroka University Medical Center
Beersheba, 84101
IsraelActive - Recruiting
Rambam Health Care Campus
Haifa, 3109601
IsraelSite Not Available
Hadassah Medical Center
Jerusalem, 9124001
IsraelActive - Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
IsraelActive - Recruiting
Schneider Children's Medical Center
Petach-Tikva, 4920235
IsraelActive - 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
Firenze, 50139
ItalyActive - Recruiting
Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale dei Bambini Vittore Buzzi
Milano, 20154
ItalyActive - Recruiting
AOU Policlinico Umberto I
Roma, 161
ItalyActive - Recruiting
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, 00165
ItalySite Not Available
Hirosaki University Hospital
Hirosaki, 036-8563
JapanActive - Recruiting
Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, 277-0871
JapanActive - Recruiting
Saga University Hospital
Saga, 849-8501
JapanActive - Recruiting
Miyagi Children's 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
Yokohama City University Medical Center
Yokohama-shi, 232-0024
JapanActive - Recruiting
Inje University Haeundae Paik Hospital
Busan, 48108
Korea, Republic ofActive - Recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
Korea, Republic ofActive - 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 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
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, 30-663
PolandSite Not Available
Korczowski Bartosz Gabinet Lekarski
Rzeszow, 35-302
PolandActive - Recruiting
Korczowski Bartosz, Gabinet Lekarski
Rzeszow, 35-302
PolandSite Not Available
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434
PolandSite Not Available
Centrum Zdrowia MDM
Warszawa, 00-635
PolandActive - Recruiting
Instytut Pomnik Centrum Zdrowia
Warszawa, 04 730
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
Lisboa, 1649-035
PortugalSite Not Available
Centro Hospitalar de Lisboa Norte Hospital Santa Maria
Lisboa, 1649-035
PortugalActive - Recruiting
Centro Hospitalar de Sao Joao E.P.E.
Porto, 4200-319
PortugalActive - Recruiting
Centro Hospitalar de São João, E.P.E.
Porto, 4200-319
PortugalSite Not Available
Hosp Reina Sofia
Córdoba, 14004
SpainActive - Recruiting
Hosp. Reina Sofia
Córdoba, 14004
SpainSite Not Available
Hosp. Infantil Univ. Niño Jesus
Madrid, 28009
SpainSite Not Available
Hosp. Univ. de La Paz
Madrid, 28046
SpainSite Not Available
Corporacio Sanitari Parc Tauli
Sabadell, 8208
SpainActive - Recruiting
Hosp. Univ. I Politecni La Fe
Valencia, 46026
SpainActive - Recruiting
INSELSPITAL, Universitätsspital Bern
Bern, 3010
SwitzerlandSite Not Available
Kinderspital Zürich
Zürich, 8032
SwitzerlandSite Not Available
King's College Hospital
Denmark Hill, SE5 9RS
United KingdomSite Not Available
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 KingdomSite Not Available
Royal Manchester Children's Hospital
Manchester, M13 9WL
United KingdomActive - Recruiting
John Radcliffe Hospital
Oxford, OX3 9DU
United KingdomActive - Recruiting
Sheffield Children's Hospital
Sheffield, S1 0 2TH
United KingdomActive - Recruiting
Phoenix Children's Hospital
Phoenix, Arizona 85016
United StatesSite Not Available
Arkansas Childrens Hospital Research Institute
Little Rock, Arkansas 72202
United StatesSite Not Available
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
University of California San Francisco
San Francisco, California 94143
United StatesSite Not Available
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 StatesActive - Recruiting
Riley Hospital for Children
Indianapolis, Indiana 46202-5225
United StatesActive - Recruiting
Boston Children's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
The Retina Inst. William Beaumont Hospital
Royal Oak, Michigan 48073
United StatesSite Not Available
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 StatesSite Not Available
Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center
New York, New York 10021-5663
United StatesActive - Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514
United StatesSite Not Available
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Palmetto Pediatric Gastroenterology & Nutrition
Columbia, South Carolina 29203
United StatesSite Not Available
East Tennessee Children's Hospital
Knoxville, Tennessee 37916
United StatesSite Not Available
Cook Childrens Medical Center
Fort Worth, Texas 76104
United StatesSite Not Available
Texas Children's Hospital
Houston, Texas 77030
United StatesSite Not Available
University of Vermont Medical Center
Colchester, Vermont 05446
United StatesActive - Recruiting
Children's Hospital of Wisconsin
Milwaukee, Wisconsin 53226-4874
United StatesSite Not Available
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