Crohn DiseasePhase 3UNITEDNCT05092269
A Long-term Extension Study of Ustekinumab in Pediatric Participants
A Phase 3 study testing Ustekinumab in people with Crohn Disease and Colitis, Ulcerative, run by Janssen Research & Development, LLC at 48 sites in 13 countries.
Trial summary
The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic
- What is being tested?
- Ustekinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 48 sitesin 13 countries
- Study dates
- 18 Oct 2021to 15 Mar 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Must have completed the dosing planned in the primary pediatric ustekinumab study
- 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
Who cannot join
- Are pregnant, nursing, or planning pregnancy or fathering a child
- 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
Trial locations and contacts
48 sites in 13 countries.
48 sites in 13 countries
Japan8 sites
Juntendo University Hospital
Bunkyō City, 113 8431
Gunma University Hospital
Gunma, 371-0034
Kindai University Nara Hospital
Ikoma, 630 0293
Kurume University Hospital
Kurume, 830-0011
Saitama Childrens Medical Center
Saitama Shi, 330-8777
Miyagi Childrens Hospital
Sendai, 989-3126
National Center for Child Health and Development
Setagaya Ku, 157 8535
Mie University Hospital
Tsu, 514 8507
Poland7 sites
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, 30 663
Korczowski Bartosz Gabinet Lekarski
Rzeszów, 35-302
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
Sosnowiec, 41 200
GASTROMED Sp. z o.o.
Torun, 87 100
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, 04 730
Medical Network 1
Warsaw, 04-501
Medical Network
Warsaw, 04-501
United Kingdom6 sites
Birmingham Children's Hospital
Birmingham, B4 6NH
Addenbrookes Hospital
Cambridge, Cb2 2qq
Royal London Hospital
London, E1 1BB
Great Ormond Street Hospital
London, WC1N 3JH
Sheffield Children's Hospital
Sheffield, S10 2TH
Southampton University Hospital
Southampton, SO16 6YD
Belgium5 sites
Huderf
Brussels, 1020
Cliniques Universitaires Saint Luc
Brussels, 1200
UZ Gent
Ghent, 9000
UZ Brussel
Jette, 1090
Uz Gasthuisberg
Leuven, 3000
Hungary5 sites
Semmelweis Egyetem
Budapest, 1083
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526
Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
Nyíregyháza, 4400
Szegedi Tudomanyegyetem
Szeged, 6720
United States4 sites
Children's Center For Digestive Healthcare, Llc
Atlanta, Georgia, 30342
Levine Childrens at Atrium Health
Charlotte, North Carolina, 28207
Pediatric Specialists Of Virginia
Fairfax, Virginia, 22031
Mount Sinai
New York, New York, 10029
Argentina3 sites
STAT Research S A
Buenos Aires, C1060
Hospital de Ninos de Cordoba
Córdoba, X5014FTO
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, T4000AXL
Israel3 sites
Yitzhak Shamir Medical Center
Beer Yaakov, 70300
Shaare Zedek Medical Center
Jerusalem, 9103102
Sheba Medical Center
Ramat Gan, 5266202
Germany2 sites
Universitaetsklinikum der RWTH Aachen
Aachen, 52074
Charite Universitatsmedizin Berlin Campus Virchow Klinikum
Berlin, 13353
Turkey (Türkiye)2 sites
Hacettepe University Medical Faculty
Ankara, 06230
Cerrahpasa Medical Faculty Hospital
Istanbul, 34098
Italy1 site
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
Milan, 20122
About this study
Official title: A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age)
The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab
- Conditions
- Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic
- Being tested
- Ustekinumab
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Also called STELARA
Ustekinumab will be administered as a SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Ustekinumab | Experimental | 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. Receives: Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
Measured: Up to 6 years and 4 months
Number of Participants With Serious Adverse Events (SAEs)
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Up to 6 years and 4 months
Number of Participants with AEs Leading to Discontinuation of Study Intervention
Number of participants with AEs leading to discontinuation of study intervention will be reported.
Measured: Up to 6 years and 4 months
Number of Participants with AEs of Interest
Number of participants with AEs of special interest (any newly identified malignancy case of active tuberculosis [TB], or opportunistic infection occurring after the first administration of study intervention[s]) will be reported.
Measured: Up to 6 years and 4 months
Number of Participants with Abnormalities in Clinical Laboratory Parameters
Number of participants with abnormalities in clinical laboratory parameters (such as hematology and serum chemistry) will be reported.
Measured: Up to 6 years and 4 months
Number of Participants with Injection-site Reactions
Number of participants with injection-site reactions will be reported. An injection-site reaction is any adverse reaction at a subcutaneous (SC) study intervention injection-site.
Measured: Up to 6 years and 4 months
Number of Participants With AEs of Worsening of the Disease
Number of participants with AEs of worsening of the disease will be reported.
Measured: Up to 6 years and 4 months
Number of Participants With Concomitant Therapy due to Loss of Response
Number of participants with concomitant therapy due to loss of response will be reported.
Measured: Up to 6 years and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start18 Oct 2021
- Primary completion29 Sep 2027 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092269
- Sponsor's protocol ID
- CR109074
- Other IDs
- CNTO1275ISD3001, 2020-004457-76, 2022-501067-40-00
- Acronym
- UNITED
- Status last verified
- Sep 2026
- First submitted
- 13 Oct 2021
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu