Phase
Condition
Crohn's Disease
Inflammatory Bowel Disease
Treatment
Guselkumab Intravenous
Guselkumab Subcutaneous
Matching Placebo
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
AustraliaSite Not Available
The Kids Research Institute Australia on behalf of the Centre for Child Health Research
Nedlands 2064874, 6009
AustraliaSite Not Available
Mater Hospital Brisbane Inflammatory Bowel Diseases
South Brisbane, 4101
AustraliaSite Not Available
Mater Hospital Brisbane Inflammatory Bowel Diseases
South Brisbane 2207259, 4101
AustraliaSite Not Available
The Children's Hospital at Westmead
Westmead, 2145
AustraliaSite Not Available
The Children's Hospital at Westmead
Westmead 2143973, 2145
AustraliaSite Not Available
CHU Charleroi Chimay
Charleroi, 6042
BelgiumSite Not Available
CHU Charleroi Chimay
Charleroi 2800481, 6042
BelgiumSite Not Available
UZ Gent
Gent, 9000
BelgiumSite Not Available
UZ Gent
Ghent 2797656, 9000
BelgiumSite Not Available
UZ Brussel
Jette, 1090
BelgiumSite Not Available
UZ Brussel
Jette 2794914, 1090
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
UZ Leuven
Leuven 2792482, 3000
BelgiumSite Not Available
Capital Institute of Pediatrics
Beijing, 100020
ChinaSite Not Available
Peking University Third Hospital
Beijing, 100191
ChinaActive - Recruiting
Capital Center For Children's health Capital Medical University
Beijing 1816670, 100020
ChinaSite Not Available
Peking University Third Hospital
Beijing 1816670, 100191
ChinaSite Not Available
Changzhou No 2 Peoples Hospital
Changzhou 1815456, 213004
ChinaSite Not Available
Changzhou No 2 Peoples Hospital
Changzhou City, 213004
ChinaSite Not Available
Changzhou No.2 People's Hospital
Changzhou City, 213004
ChinaActive - Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310016
ChinaSite Not Available
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
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou 1808926, 310016
ChinaSite Not Available
The Childrens Hospital Zhejiang University School Of Medicine
Hangzhou 1808926, 310005
ChinaSite Not Available
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, 200025
ChinaSite Not Available
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai, 200025
ChinaActive - Recruiting
Ruijin Hospital Shanghai Jiao Tong University
Shanghai 1796236, 200025
ChinaSite Not Available
Shengjing Hospital of China Medical University
Shenyang, 110004
ChinaSite Not Available
Shengjing Hospital Of China Medical University
Shenyang 2034937, 110004
ChinaSite Not Available
Henan Children's Hospital, Zhengzhou Children's Hospital
ZhengZhou, 450018
ChinaSite Not Available
Henan Children's Hospital, Zhengzhou Children's Hospital
Zhengzhou 1784658, 450052
ChinaSite Not Available
Aarhus Universitetshospital
Aarhus N, 8200
DenmarkSite Not Available
Aarhus Universitetshospital
Aarhus N 11746890, 8200
DenmarkSite Not Available
Hvidovre Hospital
Hvidovre, 2650
DenmarkSite Not Available
Hvidovre Hospital
Hvidovre 2619528, 2650
DenmarkSite Not Available
Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
Bron 3029931, 69677
FranceSite Not Available
Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
Bron cedex, 69677
FranceSite Not Available
Hospices Civils de Lyon - Groupement Hospitalier Est - Hôpital Femme Mère Enfant
Bron cedex, 69677
FranceActive - Recruiting
Hopital Francois Mitterand
Dijon, 21000
FranceSite Not Available
Hopital Francois Mitterand
Dijon 3021372, 21000
FranceSite Not Available
CHRU Lille
Lille 2998324, 59037
FranceSite Not Available
CHRU Lille
Lille Cedex, 59037
FranceSite Not Available
APHP Hopital Robert Debre
Paris, 75019
FranceSite Not Available
APHP Hopital Robert Debre
Paris 2988507, 75019
FranceSite Not Available
CHU Toulouse
Toulouse, 31059
FranceSite Not Available
CHU Toulouse
Toulouse 2972315, 31059
FranceSite Not Available
ASST Papa Giovanni XXIII Bergamo
Bergamo, 24127
ItalySite Not Available
ASST Papa Giovanni XXIII Bergamo
Bergamo 3182164, 24127
ItalySite Not Available
Azienda USL di Bologna - Ospedale Maggiore
Bologna, 40133
ItalySite Not Available
Azienda USL di Bologna - Ospedale Maggiore
Bologna 3181928, 40133
ItalySite Not Available
AOU Meyer
Firenze, 50139
ItalySite Not Available
AOU Meyer
Florence 3176959, 50139
ItalySite Not Available
Ospedale S. Spirito, Azienda Sanitaria Pescara
Pescara, 65124
ItalySite Not Available
Ospedale S. Spirito, Azienda Sanitaria Pescara
Pescara 3171168, 65124
ItalySite Not Available
AOU Policlinico Umberto I
Roma, 00161
ItalyActive - Recruiting
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, 00165
ItalySite Not Available
AOU Policlinico Umberto I
Roma 8957247, 00161
ItalySite Not Available
IRCCS Ospedale Pediatrico Bambino Gesu
Roma 8957247, 00165
ItalySite Not Available
Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013
ItalySite Not Available
Casa Sollievo della Sofferenza
San Giovanni Rotondo 3168234, 71013
ItalySite Not Available
IRCCS Materno Infantile Burlo Garofolo
Trieste, 34137
ItalySite Not Available
IRCCS Materno Infantile Burlo Garofolo
Trieste 3165185, 34137
ItalySite Not Available
Tokyo Metropolitan Children's Medical Center
Fuchu, 183 8561
JapanSite Not Available
Tokyo Metropolitan Children's Medical Center
Fuchū 11611632, 183 8561
JapanSite Not Available
Kanazawa University Hospital
Kanazawa, 920 8641
JapanSite Not Available
Kanazawa University Hospital
Kanazawa 1860243, 920 8641
JapanSite Not Available
Kobe University Hospital
Kobe, 650 0017
JapanSite Not Available
Kobe University Hospital
Kobe 1859171, 650 0017
JapanSite Not Available
Japanese Red Cross Kumamoto Hospital
Kumamoto, 861 8520
JapanSite Not Available
Japanese Red Cross Kumamoto Hospital
Kumamoto 1858421, 861 8520
JapanSite Not Available
Shinshu University Hospital
Matsumoto, 390 8621
JapanSite Not Available
Shinshu University Hospital
Matsumoto 1857519, 390 8621
JapanSite Not Available
Saga University Hospital
Saga, 849-8501
JapanSite Not Available
Saga University Hospital
Saga 1853303, 849-8501
JapanSite Not Available
National Center for Child Health and Development
Setagaya Ku, 157 8535
JapanSite Not Available
Tokyo Medical University Hospital
Shinjuku, 160 0023
JapanSite Not Available
Tokyo Medical University Hospital
Shinjuku 11790353, 160 0023
JapanSite Not Available
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, 569-8686
JapanSite Not Available
Osaka Medical and Pharmaceutical University Hospital
Takatsuki 1850910, 569-8686
JapanSite Not Available
Saiseikai Yokohamashi Tobu Hospital
Yokohama, 230-8765
JapanSite Not Available
Saiseikai Yokohamashi Tobu Hospital
Yokohama 1848354, 230-8765
JapanSite Not Available
Akershus Universitetssykehus
Lørenskog, 1478
NorwaySite Not Available
Oslo University Hospital
Oslo, 0450
NorwaySite Not Available
Oslo University Hospital
Oslo 3143244, 0450
NorwaySite Not Available
Universitetssykehuset Nord-Norge HF
Tromso, 9030
NorwaySite Not Available
Universitetssykehuset Nord-Norge HF
Tromsø 3133895, 9030
NorwaySite Not Available
St. Olavs Hospital
Trondheim, 7030
NorwaySite Not Available
St. Olavs Hospital
Trondheim 3133880, 7030
NorwaySite Not Available
Copernicus Podmiot Leczniczy Sp. z o.o
Gdansk, 80 803
PolandSite Not Available
Szpital im. M. Kopernika
Gdansk, 80 803
PolandActive - Recruiting
Copernicus Podmiot Leczniczy Sp. z o.o
Gdansk 3099434, 80 803
PolandSite Not Available
Korczowski Bartosz Gabinet Lekarski
Rzeszow, 35-302
PolandSite Not Available
Korczowski Bartosz Gabinet Lekarski
Rzeszów 759734, 35-302
PolandSite Not Available
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw 756135, 04 730
PolandSite Not Available
Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
Warsaw 756135, 04 501
PolandSite Not Available
Instytut Pomnik Centrum Zdrowia Dziecka
Warszawa, 04 730
PolandSite Not Available
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
PortugalSite Not Available
Uls Santa Maria - Hosp. Santa Maria
Lisbon 2267057, 1649-035
PortugalSite Not Available
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
PortugalSite Not Available
Uls Santo Antonio - Cmin
Porto 2735943, 4050-651
PortugalSite Not Available
Uls Sao Joao - Hosp. Sao Joao
Porto 2735943, 4200 319
PortugalSite Not Available
Hosp. Infantil Univ. Nino Jesus
Madrid, 28009
SpainSite Not Available
Hosp. Infantil Univ. Nino Jesus
Madrid 3117735, 28009
SpainSite Not Available
Corporacio Sanitari Parc Tauli
Sabadell, 08208
SpainSite Not Available
Corporacio Sanitari Parc Tauli
Sabadell 3111199, 08028
SpainSite Not Available
Hosp. Univ. I Politecni La Fe
Valencia 2509954, 46026
SpainSite Not Available
Hosp. Univ. I Politecni La Fe
València, 46026
SpainSite Not Available
Ankara University Medical Faculty
Ankara, 6620
TurkeySite Not Available
Gazi University Medical Faculty
Ankara, 06560
TurkeyActive - Recruiting
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34098
TurkeyActive - Recruiting
Marmara University Pendik Training Hospital
Istanbul, 34899
TurkeySite Not Available
Ankara University Medical Faculty
Ankara 323786, 6620
Turkey (Türkiye)Site Not Available
Gazi University Medical Faculty
Ankara 323786, 06560
Turkey (Türkiye)Site Not Available
Istanbul University Cerrahpasa Medical Faculty
Istanbul 745044, 34098
Turkey (Türkiye)Site Not Available
Marmara University Pendik Training Hospital
Istanbul 745044, 34899
Turkey (Türkiye)Site Not Available
Children's Hospital Oakland
Oakland, California 94609
United StatesSite Not Available
Children's Hospital Oakland
Oakland 5378538, California 5332921 94609
United StatesSite Not Available
Riley Hospital for Children
Indianapolis, Indiana 46202
United StatesSite Not Available
Riley Hospital for Children
Indianapolis 4259418, Indiana 4921868 46202
United StatesSite Not Available
NYU Langone Health
Lake Success, New York 11042
United StatesSite Not Available
NYU Langone Long Island Clinical Research Associates
Lake Success, New York 11042
United StatesActive - Recruiting
NYU Langone Health
Lake Success 5123853, New York 5128638 11042
United StatesSite Not Available

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