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NCT04630028CompletedPhase 3

A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 Apr 2025

Brief summary (registry, in English)

To evaluate the efficacy of ustekinumab dosing in inducing clinical remission in pediatric participants with moderately to severely active UC. To evaluate the safety profile of ustekinumab in pediatric participants with moderately to severely active UC. To evaluate ustekinumab exposure (PK).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
49 (actual)
First submitted
30 Jun 2023
Start date
15 Mar 2021
Lead sponsor
Janssen - Cilag International
EU CT number
2023-504977-19-00
EudraCT number
2019-004224-38

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 49
  • 23 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • Have UC limited to the rectum only or to less than (\<) 20 centimeter (cm) of the colon

Who the study is looking for

  • Medically stable on the basis of physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in 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 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

Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (57)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Childrens Hospital Queen Fabiola
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BrusselsBelgiumCompleted
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
UZ Brussel
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JetteBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumCompleted
Universitaetsklinikum Aachen AöR
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AachenGermanyCompleted
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
University Hospital Cologne AöR
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CologneGermanyCompleted
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyCompleted
Universitaetsklinikum Essen (AoR)
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EssenGermanyCompleted
Ludwig Maximilian University Of Munich
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MunichGermanyCompleted
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
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RegensburgGermanyCompleted
Birmingham Children's Hospital
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BirminghamUnited KingdomUnknown status
University Hospitals Bristol and Weston NHS Foundation Trust
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BristolUnited KingdomUnknown status
Cambridge University Hospitals NHS Foundation Trust
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CambridgeUnited KingdomUnknown status
Royal London Hospital
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LondonUnited KingdomUnknown status
Semmelweis University
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Budapest VIIIHungaryCompleted
University of Debrecen
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DebrecenHungaryCompleted
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
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MiskolcHungaryCompleted
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
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NyíregyházaHungaryCompleted
University of Szeged
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SzegedHungaryCompleted
Shamir Medical Center Assaf Harofeh
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Be’er Ya‘aqovIsraelUnknown status
Carmel Medical Center
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HaifaIsraelUnknown status
Rambam Medical Center
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HaifaIsraelUnknown status
Shaare Zedek Medical Center
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JerusalemIsraelUnknown status
Schneider Children's Medical Center
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Petah TikvaIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Juntendo University Hospital
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Bunkyō CityJapanUnknown status
Gunma University Hospital
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GunmaJapanUnknown status
Kindai University Nara Hospital
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IkomaJapanUnknown status
Kurume University Hospital
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KurumeJapanUnknown status
Saitama Childrens Medical Center
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Saitama ShiJapanUnknown status
Miyagi Children's Hospital
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SendaiJapanUnknown status
National Center for Child Health and Development
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Setagaya-KuJapanUnknown status
Jichi Medical University Hospital
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ShimotsukeJapanUnknown status
Mie University Hospital
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TsuJapanUnknown status
Uniwersytecki Szpital Dzieciecy W Krakowie
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CracowPolandCompleted
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandCompleted
Korczowski Bartosz, Gabinet Lekarski
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RzeszówPolandCompleted
GASTROMED Sp. z o.o.
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TorunPolandCompleted
Instytut Pomnik Centrum Zdrowia Dziecka
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WarsawPolandCompleted
WIP Warsaw IBD Point Profesor Kierkuś
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WarszawaPolandCompleted
Kazan State Medical University
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Kazan'RussiaUnknown status
Russian National Research Medical University named after N.I.Pirogov
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MoscowRussiaUnknown status
FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences
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MoscowRussiaUnknown status
Privolzhsky Research Medical University of Ministry of Health of Russian Federation
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Nizhny NovgorodRussiaUnknown status
Saratov State Medical University
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SaratovRussiaUnknown status
Yaroslavl Regional Children's Clinical Hospital
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YaroslavlRussiaUnknown status
Children's Center for Digestive Health Care
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AtlantaUnited StatesUnknown status
Levine Childrens at Atrium Health
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CharlotteUnited StatesUnknown status
University Hospitals Cleveland Medical Center*
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ClevelandUnited StatesUnknown status
Pediatric Specialists Of Virginia
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FairfaxUnited StatesUnknown status
Cook Childrens Medical Center
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Fort WorthUnited StatesUnknown status
Penn State Hershey Children's Hospital
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HersheyUnited StatesUnknown status
Morristown Memorial Hospital
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MorristownUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
Nemours DuPont Hospital for Children
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WilmingtonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.