Phase
Condition
Inflammatory Bowel Disease
Crohn's Disease
Treatment
Matching Placebo
Ustekinumab Dose Based on BSA and Body Weight
Clinical Study ID
Ages 2-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Medically stable on the basis of physical examination, medical history, and vitalsigns, performed at screening. Any abnormalities must be consistent with theunderlying illness in the study population and this determination must be recordedin the participant's source documents and acknowledged by the investigator
Must have had UC diagnosed prior to screening
Have moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with a screening Mayo endoscopy subscore greater than or equal to (>=) 2 as determined by a central review of the video of the endoscopy
A participant who has had extensive colitis for >= 8 years, or disease limited tothe left side of the colon for >= 10 years, must: a) have had a full colonoscopy toassess for the presence of dysplasia within 1 year before the first administrationof study intervention or b) have a full colonoscopy with surveillance for dysplasiaas the baseline endoscopy during the screening period. Results from thesesurveillance biopsies must be negative for dysplasia (low-grade, high-grade, orindeterminant) prior to the first administration of study intervention
Females of childbearing potential must have a negative highly sensitive urinepregnancy test at screening and at Week I-0 prior to study interventionadministration
Exclusion
Exclusion Criteria:
Have UC limited to the rectum only or to less than (<) 20 centimeter (cm) of thecolon
Presence or history of colonic or small bowel obstruction within 6 months prior toscreening, confirmed by objective radiographic or endoscopic evidence of a stricturewith resulting obstruction (dilation of the colon or small bowel proximal to thestricture on barium radiograph or an inability to traverse the stricture atendoscopy)
Have a history of latent or active granulomatous infection, histoplasmosis, orcoccidioidomycosis, or have had a nontuberculous mycobacterial infection prior toscreening
Presence or history of any malignancy including presence or history oflymphoproliferative disease including lymphoma, or signs and symptoms suggestive ofpossible lymphoproliferative disease, such as lymphadenopathy of unusual size orlocation (example, nodes in the posterior triangle of the neck, infraclavicular,epitrochlear, or periaortic areas) and monoclonal gammopathy of undeterminedsignificance, or clinically significant hepatomegaly or splenomegaly
Has known allergies, hypersensitivity, or intolerance to ustekinumab or itsexcipients
Study Design
Connect with a study center
Cliniques Universitaires Saint-Luc
Brussel, 1200
BelgiumSite Not Available
Universitair Kinderziekenhuis Koningin Fabiola
Brussel, 1020
BelgiumSite Not Available
Cliniques Universitaires Saint Luc
Bruxelles, 1200
BelgiumSite Not Available
Cliniques Universitaires Saint-Luc
Bruxelles, 1200
BelgiumActive - Recruiting
UZ Gent
Gent, 9000
BelgiumSite Not Available
UZ Brussel
Jette, 1090
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
Universitätsklinikum Aachen
Aachen, 52074
GermanySite Not Available
Charite-Universitätsmedizin Berlin - Berlin
Berlin, 13353
GermanySite Not Available
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
GermanySite Not Available
Universitatsklinikum Erlangen
Erlangen, 91054
GermanySite Not Available
Universitätsklinikum Erlangen
Erlangen, 91054
GermanyActive - Recruiting
Universitatsklinikum Essen
Essen, 45147
GermanySite Not Available
Medizinische Hochschule Hannover
Hannover, 30625
GermanySite Not Available
Universitätsklinikum Köln
Köln, 50937
GermanySite Not Available
Dr. von Haunersches Kinderspital
Munich, 80337
GermanySite Not Available
KUNO Klinik St. Hedwig
Regensburg, 93049
GermanySite Not Available
Universitatsklinikum Ulm
Ulm, 89075
GermanySite Not Available
Universitätsklinikum Ulm
Ulm, 89075
GermanyCompleted
Semmelweis Egyetem
Budapest, 1083
HungarySite Not Available
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
HungarySite Not Available
Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526
HungarySite Not Available
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526
HungaryActive - Recruiting
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526
HungarySite Not Available
Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
Nyiregyhaza, 4400
HungarySite Not Available
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz
Nyiregyhaza, 4400
HungaryActive - Recruiting
Szegedi Tudományegyetem, Gyermekgyógyászati Klinika és Gyermekegészségügyi Centrum
Szeged, 6720
HungarySite Not Available
Shamir Medical Center Assaf Harofeh
Be Er Ya Akov, 70300
IsraelSite Not Available
Shamir Medical Center (Assaf Harofeh)
Be'er Ya'akov, 70300
IsraelSite Not Available
Carmel Medical Center
Haifa, 3436212
IsraelSite Not Available
Rambam Medical Center
Haifa, 3109601
IsraelSite Not Available
Shaare Zedek Medical Center
Jerusalem, 9103102
IsraelSite Not Available
Schneider Children's Medical Center
Petah Tikva, 4920235
IsraelSite Not Available
Sheba Medical Center
Ramat Gan, 30700
IsraelSite Not Available
Juntendo University Hospital
Bunkyo Ku, 113 8431
JapanSite Not Available
Juntendo University Hospital
Bunkyo-Ku, 113-8431
JapanSite Not Available
Kurume University Hospital
Fukuoka, 830-0011
JapanSite Not Available
Gunma University Hospital
Gunma, 371-0034
JapanSite Not Available
Kindai University Nara Hospital
Ikoma, 630-0293
JapanSite Not Available
Osaka Women's and Children's Hospital
Izumi-shi, Osaka, 594-1101
JapanSite Not Available
Kurume University Hospital
Kurume, 830-0011
JapanSite Not Available
Aichi Children's Health and Medical Center
Obu, 474-0031
JapanSite Not Available
Saitama Childrens Medical Center
Saitama shi, 330-8777
JapanSite Not Available
Saitama Children's Medical Center
Saitama-shi, 330-8777
JapanSite Not Available
Miyagi Children's Hospital
Sendai, 989-3126
JapanSite Not Available
Miyagi Children'S Hospital
Sendai-shi, 989-3126
JapanSite Not Available
National Center for Child Health and Development
Setagaya Ku, 157 8535
JapanSite Not Available
National Center for Child Health and Development
Setagaya-ku, 157-8535
JapanSite Not Available
Jichi Medical University Hospital
Shimotsuke, 329-0498
JapanSite Not Available
Mie University Hospital
Tsu, 514 8507
JapanSite Not Available
Szpital im. M. Kopernika
Gdansk, 80 803
PolandSite Not Available
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, 30 663
PolandSite Not Available
Korczowski Bartosz Gabinet Lekarski
Rzeszow, 35-302
PolandSite Not Available
Korczowski Bartosz, Gabinet Lekarski
Rzeszow, 35-302
PolandActive - Recruiting
GASTROMED Sp. z o.o.
Torun, 87 100
PolandSite Not Available
Instytut Pomnik - Centrum Zdrowia Dziecka
Warszawa, 04-730
PolandActive - Recruiting
Instytut Pomnik Centrum Zdrowia Dziecka
Warszawa, 04 730
PolandSite Not Available
Medical Network
Warszawa, 04-501
PolandSite Not Available
WIP Warsaw IBD Point Profesor Kierkus
Warszawa, 04 501
PolandSite Not Available
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-369
PolandSite Not Available
Kazan State Medical University
Kazan, 420138
Russian FederationSite Not Available
Kemerovo Regional Clinical Hospital
Kemerovo, 650066
Russian FederationSite Not Available
Krasnoyarsk State Medical University
Krasnoyarsk, 660022
Russian FederationSite Not Available
FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences
Moscow, 119991
Russian FederationSite Not Available
Russian National Research Medical University named after N.I.Pirogov
Moscow, 119571
Russian FederationSite Not Available
Privolzhsky Research Medical University of Ministry of Health of Russian Federation
Nizhny Novgorod, 603950
Russian FederationSite Not Available
Saratov State Medical University
Saratov, 410054
Russian FederationSite Not Available
Yaroslavl Regional Children's Clinical Hospital
Yaroslavl, 150032
Russian FederationSite Not Available
Birmingham Children's Hospital
Birmingham, B4 6NH
United KingdomSite Not Available
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, BS2 8BJ
United KingdomSite Not Available
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
United KingdomSite Not Available
Royal Hospital for Children and Young People
Edinburgh, EH16 4TJ
United KingdomSite Not Available
King's College Hospital
London, SE5 9RS
United KingdomSite Not Available
Royal London Hospital
London, E1 2AT
United KingdomSite Not Available
Nemours DuPont Hospital for Children
Wilmington, Delaware 19803
United StatesSite Not Available
Children's Center for Digestive Health Care
Atlanta, Georgia 30342
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Morristown Memorial Hospital
Morristown, New Jersey 07962
United StatesSite Not Available
Cohen Children's Medical Center
Lake Success, New York 11042
United StatesSite Not Available
Levine Children's at Atrium Health
Charlotte, North Carolina 28207
United StatesActive - Recruiting
Levine Childrens at Atrium Health
Charlotte, North Carolina 28207
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Penn State Hershey Children's Hospital
Hershey, Pennsylvania 17033
United StatesSite Not Available
Center For Digestive Health Systems-Greenville
Greenville, South Carolina 29615
United StatesSite Not Available
Children's Medical Center of Dallas
Dallas, Texas 75207
United StatesSite Not Available
Cook Childrens Medical Center
Fort Worth, Texas 76104
United StatesSite Not Available
Pediatric Specialists Of Virginia
Fairfax, Virginia 22031
United StatesSite Not Available
Seattle Children's Hospital
Seattle, Washington 98105
United StatesSite Not Available
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