The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics [PK]) in pediatric participants with moderately to severely active UC.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 2 Years - 17 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04630028 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Janssen Research & Development, LLC |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Janssen Research & Development, LLC Clinical Trial |
Principal Investigator Affiliation | Janssen Research & Development, LLC |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Belgium, Germany, Hungary, Israel, Japan, Poland, Russian Federation, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Colitis, Ulcerative |
Experimental: Induction Period (I): Ustekinumab
All participants will receive a single intravenous (IV) administration of ustekinumab at induction Week 0 (I-0) based on body surface area (BSA) (milligram per meter square [mg/m^2]) or weight-tiered induction dose (milligram per kilogram [mg/kg]).
Experimental: Maintenance (M) Period: Ustekinumab once every 8 Week (q8w)
Participants will receive subcutaneous (SC) administration of ustekinumab every 8 weeks (q8w) based on BSA (mg/m^2) or weight-tiered induction dose (mg/kg) at Weeks M-0, M-8, M-16, M-24, M-32, M-40 and matching placebo at Weeks M-12 and M-36 to maintain the blind.
Experimental: Maintenance (M) Period: Ustekinumab once every 12 Week (q12w)
Participants will receive SC administration of ustekinumab every 12 weeks (q12w) based on BSA (mg/m^2) or weight-tiered induction dose (mg/kg) at Weeks M-0, M-12, M-24, M-36 and matching placebo at Weeks M-8, M-16, M-32, and M-40 to maintain the blind.
Drug: - Ustekinumab Dose Based on BSA and Body Weight
As per BSA and body weight Ustekinumab will be administered SC and IV.
Drug: - Matching Placebo
Placebo will be administered subcutaneously.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Nemours DuPont Hospital for Children
Wilmington, Delaware, 19803
Status
Recruiting
Address
Children's Center for Digestive Health Care
Atlanta, Georgia, 30342
Status
Recruiting
Address
Mayo Clinic
Rochester, Minnesota, 55905
Status
Recruiting
Address
Morristown Memorial Hospital
Morristown, New Jersey, 07962
Status
Withdrawn
Address
Cohen Children's Medical Center
Lake Success, New York, 11042
Status
Recruiting
Address
Levine Children's at Atrium Health
Charlotte, North Carolina, 28207
Status
Recruiting
Address
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Status
Withdrawn
Address
Cleveland Clinic
Cleveland, Ohio, 44195
Status
Recruiting
Address
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, 17033
Status
Withdrawn
Address
Center For Digestive Health Systems-Greenville
Greenville, South Carolina, 29615
Status
Withdrawn
Address
Children's Medical Center of Dallas
Dallas, Texas, 75390-9063
Status
Not yet recruiting
Address
Cook Childrens Medical Center
Fort Worth, Texas, 76104
Status
Recruiting
Address
Pediatric Specialists Of Virginia
Fairfax, Virginia, 22031
Status
Withdrawn
Address
Seattle Children's Hospital
Seattle, Washington, 98105
Status
Recruiting
Address
Universitair Kinderziekenhuis Koningin Fabiola
Brussel, , 1020
Status
Recruiting
Address
Cliniques Universitaires Saint-Luc
Brussel, , 1200
Status
Recruiting
Address
UZ Gent
Gent, , 9000
Status
Recruiting
Address
UZ Brussel
Jette, , 1090
Status
Recruiting
Address
UZ Leuven
Leuven, , 3000
Status
Recruiting
Address
Universitätsklinikum Aachen
Aachen, , 52074
Status
Recruiting
Address
Charite-Universitätsmedizin Berlin - Berlin
Berlin, , 13353
Status
Not yet recruiting
Address
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , 01307
Status
Recruiting
Address
Universitatsklinikum Essen
Essen, , 45147
Status
Recruiting
Address
Medizinische Hochschule Hannover
Hannover, , 30625
Status
Not yet recruiting
Address
Universitätsklinikum Köln
Köln, , 50937
Status
Recruiting
Address
Dr. von Haunersches Kinderspital
Munich, , 80337
Status
Recruiting
Address
KUNO Klinik St. Hedwig
Regensburg, , 93049
Status
Completed
Address
Universitätsklinikum Ulm
Ulm, , 89075
Status
Recruiting
Address
Semmelweis Egyetem
Budapest, , 1083
Status
Recruiting
Address
Debreceni Egyetem Klinikai Kozpont
Debrecen, , 4032
Status
Recruiting
Address
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, , 3526
Status
Recruiting
Address
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz
Nyiregyhaza, , 4400
Status
Recruiting
Address
Szegedi Tudományegyetem, Gyermekgyógyászati Klinika és Gyermekegészségügyi Centrum
Szeged, , 6720
Status
Not yet recruiting
Address
Shamir Medical Center (Assaf Harofeh)
Be'er Ya'akov, , 70300
Status
Not yet recruiting
Address
Rambam Medical Center
Haifa, , 3109601
Status
Not yet recruiting
Address
Carmel Medical Center
Haifa, , 3436212
Status
Not yet recruiting
Address
Shaare Zedek Medical Center
Jerusalem, , 9103102
Status
Not yet recruiting
Address
Schneider Children's Medical Center
Petah Tikva, , 4920235
Status
Not yet recruiting
Address
Sheba Medical Center
Ramat Gan, , 30700
Status
Recruiting
Address
Juntendo University Hospital
Bunkyo-Ku, , 113-8431
Status
Recruiting
Address
Gunma University Hospital
Gunma, , 371-0034
Status
Recruiting
Address
Kindai University Nara Hospital
Ikoma, , 630-0293
Status
Withdrawn
Address
Osaka Women's and Children's Hospital
Izumi-shi, Osaka, , 594-1101
Status
Recruiting
Address
Kurume University Hospital
Kurume, , 830-0011
Status
Withdrawn
Address
Aichi Children's Health and Medical Center
Obu, , 474-0031
Status
Recruiting
Address
Saitama Children's Medical Center
Saitama-shi, , 330-8777
Status
Recruiting
Address
Miyagi Children'S Hospital
Sendai-shi, , 989-3126
Status
Recruiting
Address
National Center for Child Health and Development
Setagaya-ku, , 157-8535
Status
Recruiting
Address
Jichi Medical University Hospital
Shimotsuke, , 329-0498
Status
Recruiting
Address
Mie University Hospital
Tsu, , 514-8507
Status
Completed
Address
Szpital im. M. Kopernika
Gdansk, , 80-803
Status
Recruiting
Address
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, , 30-663
Status
Recruiting
Address
Korczowski Bartosz, Gabinet Lekarski
Rzeszow, , 35-302
Status
Recruiting
Address
GASTROMED Sp. z .o.o.
Torun, , 87-100
Status
Recruiting
Address
WIP Warsaw IBD Point Profesor Kierkus
Warszawa, , 00-728
Status
Recruiting
Address
Instytut Pomnik - Centrum Zdrowia Dziecka
Warszawa, , 04-730
Status
Withdrawn
Address
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, , 50-369
Status
Completed
Address
Kazan State Medical University
Kazan, , 420138
Status
Withdrawn
Address
Kemerovo Regional Clinical Hospital
Kemerovo, , 650066
Status
Completed
Address
Russian National Research Medical University named after N.I.Pirogov
Moscow, , 119571
Status
Completed
Address
FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences
Moscow, , 119991
Status
Completed
Address
Privolzhsky Research Medical University of Ministry of Health of Russian Federation
Nizhny Novgorod, , 603950
Status
Completed
Address
Saratov State Medical University
Saratov, , 410054
Status
Completed
Address
Yaroslavl Regional Children's Clinical Hospital
Yaroslavl, , 150032
Status
Recruiting
Address
Birmingham Children's Hospital
Birmingham, , B4 6NH
Status
Recruiting
Address
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , CB2 0QQ
Status
Not yet recruiting
Address
Royal Hospital for Children and Young People
Edinburgh, , EH16 4TJ
Status
Recruiting
Address
Royal London Hospital
London, , E1 2AT
Status
Withdrawn
Address
King's College Hospital
London, , SE5 9RS
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