Phase
Condition
Inflammatory Bowel Disease
Crohn's Disease
Treatment
Guselkumab
Guselkumab Subcutaneous
Guselkumab Intravenous
Clinical Study ID
Ages 2-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Weight greater than or equal to (>=) 10 kilogram (kg) at the time of consent forscreening
A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) mustbe available in the source documents. There is no maximum duration for which aparticipant needs to be diagnosed with UC. If the pathology report to support adocumented diagnosis of UC is not available in the source documents, the screeningendoscopy with biopsies (obtained within 3 weeks before first study interventionadministration) needs to support the diagnosis of UC.
Moderately to severely active UC, defined by a baseline modified Mayo (withoutphysician's global assessment) score of 5 through 9 inclusive, with a screening Mayoendoscopy subscore >= 2 as determined by a central review of the video of theendoscopy
Medically stable based on physical examination, medical history, and vital signs,performed at screening. Any abnormalities must be consistent with the underlyingillness in the study population and this determination must be recorded in theparticipant's source documents and acknowledged by the investigator
Participants must have had an inadequate response and/or intolerance to biologictherapy and/or conventional therapies or be dependent upon corticosteroids
Exclusion
Exclusion Criteria:
Have UC limited to the rectum only or to less than (<) 20 centimeter of the colon
Presence of a stoma
Has had any kind of bowel resection within 6 months or any other intra-abdominalsurgery within 3 months of baseline
Have severe colitis or have evidence of Crohn's Disease (CD)
Study Design
Connect with a study center
Perth Children's Hospital
Nedlands, 6009
AustraliaActive - Recruiting
The Kids Research Institute Australia on behalf of the Centre for Child Health Research
Nedlands, 6009
AustraliaActive - Recruiting
Mater Hospital Brisbane Inflammatory Bowel Diseases
South Brisbane, 4101
AustraliaActive - Recruiting
The Children's Hospital at Westmead
Westmead, 2145
AustraliaActive - Recruiting
CHU Charleroi Chimay
Charleroi, 6042
BelgiumActive - Recruiting
UZ Gent
Gent, 9000
BelgiumActive - Recruiting
UZ Brussel
Jette, 1090
BelgiumActive - Recruiting
UZ Leuven
Leuven, 3000
BelgiumActive - Recruiting
Capital Institute of Pediatrics
Beijing, 100020
ChinaActive - Recruiting
Peking University Third Hospital
Beijing, 100191
ChinaActive - Recruiting
Changzhou No 2 Peoples Hospital
Changzhou City, 213004
ChinaActive - Recruiting
Changzhou No.2 People's Hospital
Changzhou City, 213004
ChinaActive - Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310016
ChinaActive - Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, 310016
ChinaActive - Recruiting
The Childrens Hospital Zhejiang University School Of Medicine
Hangzhou, 310005
ChinaActive - Recruiting
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, 200025
ChinaActive - Recruiting
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai, 200025
ChinaActive - Recruiting
Shengjing Hospital Of China Medical University
Shenyang, 110004
ChinaActive - Recruiting
Henan Children's Hospital, Zhengzhou Children's Hospital
ZhengZhou, 450018
ChinaActive - Recruiting
Aarhus Universitetshospital
Aarhus N, 8200
DenmarkActive - Recruiting
Hvidovre Hospital
Hvidovre, 2650
DenmarkActive - Recruiting
Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
Bron cedex, 69677
FranceActive - Recruiting
Hospices Civils de Lyon - Groupement Hospitalier Est - Hôpital Femme Mère Enfant
Bron cedex, 69677
FranceActive - Recruiting
Hopital Francois Mitterand
Dijon, 21000
FranceActive - Recruiting
CHRU Lille
Lille Cedex, 59037
FranceActive - Recruiting
APHP Hopital Robert Debre
Paris, 75019
FranceActive - Recruiting
CHU Toulouse
Toulouse, 31059
FranceActive - Recruiting
Azienda USL di Bologna - Ospedale Maggiore
Bologna, 40133
ItalyActive - Recruiting
AOU Meyer
Firenze, 50139
ItalyActive - Recruiting
Ospedale S. Spirito, Azienda Sanitaria Pescara
Pescara, 65124
ItalyActive - Recruiting
AOU Policlinico Umberto I
Roma, 00161
ItalyActive - Recruiting
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, 00165
ItalyActive - Recruiting
Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013
ItalyActive - Recruiting
IRCCS Materno Infantile Burlo Garofolo
Trieste, 34137
ItalyActive - Recruiting
Tokyo Metropolitan Children's Medical Center
Fuchu, 183 8561
JapanActive - Recruiting
Kanazawa University Hospital
Kanazawa, 920 8641
JapanActive - Recruiting
Kobe University Hospital
Kobe, 650 0017
JapanActive - Recruiting
Japanese Red Cross Kumamoto Hospital
Kumamoto, 861 8520
JapanActive - Recruiting
Shinshu University Hospital
Matsumoto, 390 8621
JapanActive - Recruiting
Saga University Hospital
Saga, 849-8501
JapanActive - Recruiting
National Center for Child Health and Development
Setagaya Ku, 157 8535
JapanActive - Recruiting
Tokyo Medical University Hospital
Shinjuku, 160-0023
JapanActive - Recruiting
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, 569-8686
JapanActive - Recruiting
Saiseikai Yokohamashi Tobu Hospital
Yokohama, 230-8765
JapanActive - Recruiting
Akershus Universitetssykehus
Lørenskog, 1478
NorwayActive - Recruiting
Oslo University Hospital
Oslo, 0450
NorwayActive - Recruiting
Universitetssykehuset Nord-Norge HF
Tromso, 9030
NorwayActive - Recruiting
St. Olavs Hospital
Trondheim, 7030
NorwayActive - Recruiting
Korczowski Bartosz Gabinet Lekarski
Rzeszow, 35-302
PolandActive - Recruiting
Instytut Pomnik Centrum Zdrowia Dziecka
Warszawa, 04 730
PolandActive - Recruiting
Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
Warszawa, 04 501
PolandActive - Recruiting
Chln - Hosp. Santa Maria
Lisboa, 1649-035
PortugalActive - Recruiting
Uls Santa Maria - Hosp. Santa Maria
Lisboa, 1649-035
PortugalActive - Recruiting
Chp - Centro Materno Infantil Do Norte
Porto, 4050-651
PortugalActive - Recruiting
Chsj - Hosp. Sao Joao
Porto, 4200 319
PortugalActive - Recruiting
Uls Santo Antonio - Cmin
Porto, 4050-651
PortugalActive - Recruiting
Uls Sao Joao - Hosp. Sao Joao
Porto, 4200 319
PortugalActive - Recruiting
Hosp. Infantil Univ. Nino Jesus
Madrid, 28009
SpainActive - Recruiting
Corporacio Sanitari Parc Tauli
Sabadell, 08208
SpainActive - Recruiting
Hosp. Univ. I Politecni La Fe
València, 46026
SpainActive - Recruiting
Ankara University Medical Faculty
Ankara, 6620
TurkeyActive - Recruiting
Gazi University Medical Faculty
Ankara, 06560
TurkeyActive - Recruiting
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34098
TurkeyActive - Recruiting
Marmara University Pendik Training Hospital
Istanbul, 34899
TurkeyActive - Recruiting
Riley Hospital for Children
Indianapolis, Indiana 46202
United StatesActive - Recruiting
NYU Langone Health
Lake Success, New York 11042
United StatesActive - Recruiting
NYU Langone Long Island Clinical Research Associates
Lake Success, New York 11042
United StatesActive - Recruiting
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