A Long-term Extension Study of Ustekinumab in Pediatric Participants
NCT ID: NCT05092269
Last Updated: 2025-11-10
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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RECRUITING
PHASE3
151 participants
INTERVENTIONAL
2021-10-18
2027-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Ustekinumab
Participants will have continued access to ustekinumab for primary study (CNTO1275CRD1001, CNTO1275PUC3001, CNTO1275CRD3004, CNTO1275JPA3001) participants who in the opinion of the investigator will continue to benefit from ustekinumab therapy. All blinded participants who enroll in the long-term extension (LTE) from blinded primary studies with both every 8 weeks (q8w) and every 12 weeks (q12w) dosing groups just prior to the end of the primary study will be assigned to the q8w dosing regimen. Participants enrolling in the LTE from an unblinded primary study will remain on the final dosing regimen that they were receiving in the primary study. Participants enrolling from the Exposure Optimization Substudy may be eligible to remain on the every 4 weeks (q4w) dosing regimen.
Ustekinumab
Ustekinumab will be administered as a SC injection.
Interventions
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Ustekinumab
Ustekinumab will be administered as a SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Benefit of continued ustekinumab therapy (that is, a clinical response or clinical remission as defined in the primary study at the final efficacy visit of the primary study)
* Parent(s) (preferably both if available or as per local requirements), legal guardian(s) or their legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) as described in Informed Consent Process. An adolescent who signs the assent form will be given the opportunity to sign an adult ICF at a later visit when they reach the age of majority during the study to indicate that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
* Females of childbearing potential must have a negative urine pregnancy test at enrollment and prior to study intervention administration
Exclusion Criteria
* Have had any of (a) confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2 \[COVID-19\]) infection (test positive), or (b) suspected SARS-CoV-2 infection (clinical features without documented test results), or (c) close contact with a person with known or suspected SARS-CoV-2 infection: Exception: (i) may be included with a documented negative result for a validated SARS-CoV-2 test: obtained at least 2 weeks after conditions (a), (b), (c) above (timed from resolution of key clinical features if present, example, fever, cough, dyspnea) and (ii) with absence of all conditions (a), (b), (c) above during the period between the negative test result and the baseline study visit
* Taken any disallowed therapies as noted in the primary study, before the planned first long-term extension (LTE) dose of study intervention
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Participants who receive a live vaccination may be permitted to remain in the study, if approved by the sponsor and study intervention is held for a period of time specified by the sponsor. Receipt of a live severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) vaccine (against the virus that causes Coronavirus Disease 2019 \[COVID-19\]) is not automatically an exclusion criterion and must be discussed with the medical monitor
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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Children's Center For Digestive Healthcare, Llc
Atlanta, Georgia, United States
Mount Sinai
New York, New York, United States
Levine Childrens at Atrium Health
Charlotte, North Carolina, United States
Pediatric Specialists Of Virginia
Fairfax, Virginia, United States
STAT Research S A
Buenos Aires, , Argentina
Hospital de Ninos de Cordoba
Córdoba, , Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, , Argentina
Huderf
Brussels, , Belgium
Cliniques Universitaires Saint Luc
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
UZ Brussel
Jette, , Belgium
Uz Gasthuisberg
Leuven, , Belgium
Hôpital Necker
Paris, , France
Universitaetsklinikum der RWTH Aachen
Aachen, , Germany
Charite Universitatsmedizin Berlin Campus Virchow Klinikum
Berlin, , 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 Tudomanyegyetem
Szeged, , Hungary
Yitzhak Shamir Medical Center
Beer Yaakov, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
Milan, , Italy
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
Mie University Hospital
Tsu, , Japan
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, , Poland
Korczowski Bartosz Gabinet Lekarski
Rzeszów, , Poland
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
Sosnowiec, , Poland
GASTROMED Sp. z o.o.
Torun, , Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, , Poland
Medical Network
Warsaw, , Poland
Hosp. Univ. I Politecni La Fe
Valencia, , Spain
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Cerrahpasa Medical Faculty Hospital
Istanbul, , Turkey (Türkiye)
Birmingham Children's Hospital
Birmingham, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Royal London Hospital
London, , United Kingdom
Great Ormond Street Hospital
London, , United Kingdom
Sheffield Children's Hospital
Sheffield, , United Kingdom
Southampton University Hospital
Southampton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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CNTO1275ISD3001
Identifier Type: OTHER
Identifier Source: secondary_id
2020-004457-76
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-501067-40-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109074
Identifier Type: -
Identifier Source: org_study_id