A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)
NCT ID: NCT04630028
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
112 participants
INTERVENTIONAL
2021-03-17
2025-06-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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 \[mg/kg\]).
Ustekinumab Dose Based on BSA and Body Weight
As per BSA and body weight Ustekinumab will be administered SC and IV.
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.
Ustekinumab Dose Based on BSA and Body Weight
As per BSA and body weight Ustekinumab will be administered SC and IV.
Matching Placebo
Placebo will be administered subcutaneously.
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.
Ustekinumab Dose Based on BSA and Body Weight
As per BSA and body weight Ustekinumab will be administered SC and IV.
Matching Placebo
Placebo will be administered subcutaneously.
Interventions
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Ustekinumab Dose Based on BSA and Body Weight
As per BSA and body weight Ustekinumab will be administered SC and IV.
Matching Placebo
Placebo will be administered subcutaneously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 to the left side of the colon for \>= 10 years, must: a) have had a full colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study intervention or b) have a full colonoscopy with surveillance for dysplasia as the baseline endoscopy during the screening period. Results from these surveillance biopsies must be negative for dysplasia (low-grade, high-grade, or indeterminant) prior to the first administration of study intervention
* Females of childbearing potential must have a negative highly sensitive urine pregnancy test at screening and at Week I-0 prior to study intervention administration
Exclusion Criteria
* Presence or history of colonic or small bowel obstruction within 6 months prior to screening, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy)
* Have a history of latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to screening
* Presence or history of any malignancy including presence or history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (example, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas) and monoclonal gammopathy of undetermined significance, or clinically significant hepatomegaly or splenomegaly
* Has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients
2 Years
17 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Nemours DuPont Hospital for Children
Wilmington, Delaware, United States
Children's Center for Digestive Health Care
Atlanta, Georgia, United States
Mayo Clinic
Rochester, Minnesota, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Levine Childrens at Atrium Health
Charlotte, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States
Cook Childrens Medical Center
Fort Worth, Texas, United States
Pediatric Specialists Of Virginia
Fairfax, Virginia, United States
Universitair Kinderziekenhuis Koningin Fabiola
Brussels, , Belgium
Cliniques Universitaires Saint Luc
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
UZ Brussel
Jette, , Belgium
UZ Leuven
Leuven, , Belgium
Universitätsklinikum Aachen
Aachen, , Germany
Charite-Universitätsmedizin Berlin - Berlin
Berlin, , Germany
Universitatsklinikum Erlangen
Erlangen, , Germany
Universitatsklinikum Essen
Essen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Dr. von Haunersches Kinderspital
Munich, , Germany
KUNO Klinik St. Hedwig
Regensburg, , Germany
Universitatsklinikum Ulm
Ulm, , Germany
Semmelweis Egyetem
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc, , Hungary
Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
Nyíregyháza, , Hungary
Szegedi Tudományegyetem, Gyermekgyógyászati Klinika és Gyermekegészségügyi Centrum
Szeged, , Hungary
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov, , Israel
Rambam Medical Center
Haifa, , Israel
Carmel Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Schneider Children's Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Juntendo University Hospital
Bunkyō City, , Japan
Gunma University Hospital
Gunma, , Japan
Kindai University Nara Hospital
Ikoma, , Japan
Kurume University Hospital
Kurume, , Japan
Saitama Childrens Medical Center
Saitama Shi, , Japan
Miyagi Children's Hospital
Sendai, , Japan
National Center for Child Health and Development
Setagaya Ku, , Japan
Jichi Medical University Hospital
Shimotsuke, , Japan
Mie University Hospital
Tsu, , Japan
Szpital im. M. Kopernika
Gdansk, , Poland
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, , Poland
Korczowski Bartosz Gabinet Lekarski
Rzeszów, , Poland
GASTROMED Sp. z o.o.
Torun, , Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, , Poland
Kazan State Medical University
Kazan', , Russia
Russian National Research Medical University named after N.I.Pirogov
Moscow, , Russia
FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences
Moscow, , Russia
Privolzhsky Research Medical University of Ministry of Health of Russian Federation
Nizhny Novgorod, , Russia
Saratov State Medical University
Saratov, , Russia
Yaroslavl Regional Children's Clinical Hospital
Yaroslavl, , Russia
Birmingham Children's Hospital
Birmingham, , United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
Royal London Hospital
London, , United Kingdom
Countries
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Other Identifiers
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CNTO1275PUC3001
Identifier Type: OTHER
Identifier Source: secondary_id
2019-004224-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-504977-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR108865
Identifier Type: -
Identifier Source: org_study_id
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