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
- Diseases
- Ulcerative colitis
- 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
Sites (57)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Childrens Hospital Queen Fabiola Coordinator of this site? Confirm its status | Brussels | Belgium | Completed |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Completed |
| Universitaetsklinikum Aachen AöR Coordinator of this site? Confirm its status | Aachen | Germany | Completed |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Completed |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Completed |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Ludwig Maximilian University Of Munich Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH Coordinator of this site? Confirm its status | Regensburg | Germany | Completed |
| Birmingham Children's Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| University Hospitals Bristol and Weston NHS Foundation Trust Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Cambridge University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Royal London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Completed |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Coordinator of this site? Confirm its status | Miskolc | Hungary | Completed |
| Szabolcs Szatmár Bereg Vármegyei Oktatókórház Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Completed |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Completed |
| Shamir Medical Center Assaf Harofeh Coordinator of this site? Confirm its status | Be’er Ya‘aqov | Israel | Unknown status |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Schneider Children's Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| Gunma University Hospital Coordinator of this site? Confirm its status | Gunma | Japan | Unknown status |
| Kindai University Nara Hospital Coordinator of this site? Confirm its status | Ikoma | Japan | Unknown status |
| Kurume University Hospital Coordinator of this site? Confirm its status | Kurume | Japan | Unknown status |
| Saitama Childrens Medical Center Coordinator of this site? Confirm its status | Saitama Shi | Japan | Unknown status |
| Miyagi Children's Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| National Center for Child Health and Development Coordinator of this site? Confirm its status | Setagaya-Ku | Japan | Unknown status |
| Jichi Medical University Hospital Coordinator of this site? Confirm its status | Shimotsuke | Japan | Unknown status |
| Mie University Hospital Coordinator of this site? Confirm its status | Tsu | Japan | Unknown status |
| Uniwersytecki Szpital Dzieciecy W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Copernicus Podmiot Leczniczy Sp. z o.o Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Korczowski Bartosz, Gabinet Lekarski Coordinator of this site? Confirm its status | Rzeszów | Poland | Completed |
| GASTROMED Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Completed |
| Instytut Pomnik Centrum Zdrowia Dziecka Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| WIP Warsaw IBD Point Profesor Kierkuś Coordinator of this site? Confirm its status | Warszawa | Poland | Completed |
| Kazan State Medical University Coordinator of this site? Confirm its status | Kazan' | Russia | Unknown status |
| Russian National Research Medical University named after N.I.Pirogov Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Privolzhsky Research Medical University of Ministry of Health of Russian Federation Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Unknown status |
| Saratov State Medical University Coordinator of this site? Confirm its status | Saratov | Russia | Unknown status |
| Yaroslavl Regional Children's Clinical Hospital Coordinator of this site? Confirm its status | Yaroslavl | Russia | Unknown status |
| Children's Center for Digestive Health Care Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Levine Childrens at Atrium Health Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Pediatric Specialists Of Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Cook Childrens Medical Center Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Penn State Hershey Children's Hospital Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Morristown Memorial Hospital Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Nemours DuPont Hospital for Children Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.