A long-term extension study of ustekinumab in pediatric participants with different medical conditions
| ISRCTN | ISRCTN36985527 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36985527 |
| EudraCT/CTIS number | 2020-004457-76 |
| IRAS number | 1005154 |
| ClinicalTrials.gov number | NCT05092269 |
| Secondary identifying numbers | CNTO1275ISD3001, IRAS 1005154, CPMS 52012 |
- Submission date
- 20/01/2023
- Registration date
- 09/08/2023
- Last edited
- 01/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Ustekinumab is a study drug that has been studied in adult participants with Crohn’s disease, ulcerative colitis and psoriatic arthritis. It is now being studied in paediatric participants with the conditions of paediatric Crohn’s disease, paediatric ulcerative colitis and juvenile psoriatic arthritis. The purpose of this study is to collect long‐term safety data in those paediatric study participants and to provide continued access to the study drug ustekinumab to the paediatric study participants, who in the opinion of the investigator, will continue to benefit from ustekinumab therapy. This study is considered a long‐term extension (LTE) study.
Who can participate?
Participants who successfully completed one of four primary studies, aged 2 – 17 years old
What does the study involve?
The study has three parts:
Enrolment visit (W‐0): eligible participants will sign the informed consent to join the study
Treatment period: participants will be seen at least once every 6 months and continue to take ustekinumab during this time, based on the protocol specified dosing schedule
Safety follow-up visit: participants will be seen 20 weeks after the last administration of ustekinumab
During study visits a variety of tests will be carried out including, but not limited to, vital signs, physical exam, questionnaires and blood and urine samples.
What are the possible benefits and risks of participating?
There is no established benefit to participants of this study. Based on scientific theory, taking ustekinumab may improve the participants' condition (paediatric Crohn’s disease, paediatric ulcerative colitis or juvenile psoriatic arthritis). However, this cannot be guaranteed because ustekinumab is still under investigation as a treatment and it is not known whether ustekinumab will work.
Participants may experience some benefit from participation in the study that is not due to receiving study drug, but due to regular visits and assessments monitoring overall health. Participation may help other people with paediatric Crohn’s disease, paediatric ulcerative colitis or
juvenile psoriatic arthritis in the future.
Participants may have side effects from the drugs or procedures used in this study that may be mild to severe and even life‐threatening, and they can vary from person to person. The most common, known risks are getting symptoms such as headache, sore throat, tiredness, vomiting or diarrhea after getting the study drug. There are other, less frequent risks. The participant information sheet and informed consent form include a detailed section outlining the known risks of participating in the study.
Where is the study run from?
Janssen-Cilag International NV (Netherlands)
When is the study starting and how long is it expected to run for?
January 2023 to September 2027
Who is funding the study?
Janssen Research & Development
Who is the main contact?
medinfo@its.jnj.com
Contact information
Public, Scientific
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-
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United Kingdom
| Phone | +44(0)800 7318450 |
|---|---|
| medinfo@its.jnj.com |
Principal Investigator
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Study information
| Study design | Non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment, Safety |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A Phase III, multicenter, open-label, basket, long-term extension study of ustekinumab in pediatric clinical study participants (2 to <18 years of age) |
| Study acronym | UNITED |
| Study objectives | Long-term safety data on ustekinumab in pediatric clinical study participants (2 to <18 years of age) |
| Ethics approval(s) |
Approved 09/08/2023, West Midlands - Edgbaston Research Ethics Committee (3rd Floor, Barlow House, Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)2071048248; edgbaston.rec@hra.nhs.uk), ref: 23/WM/0019 |
| Health condition(s) or problem(s) studied | Moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis, juvenile psoriatic arthritis |
| Intervention | Participants will have continued access to ustekinumab if they complete the primary parent study (CNTO1275PUC3001, CNTO1275CRD3004) and in the opinion of the investigator will continue to benefit from ustekinumab therapy. Participants will either be given Q8W or Q4W ustekinumab subcutaneously, depending on the regimen that they were receiving in the primary study. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Ustekinumab |
| Primary outcome measure | 1. Adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation of study intervention, and AEs of special interest (as determined for each indication) 2. Clinical laboratory hematology and chemistry 3. Injection-site reactions 4. AEs of worsening of the disease under study 5. An addition of concomitant therapy due to loss of response Collected from patients' medical records from enrolment to the end of study participation |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 18/01/2023 |
| Completion date | 29/09/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 180 |
| Key inclusion criteria | 1. Males or females 2 to <18 years of age, inclusive (at the time of the first administration of study intervention during the LTE) 2. Must have completed the dosing planned in the primary pediatric ustekinumab study 3. Benefit of continued ustekinumab therapy (i.e., a clinical response or clinical remission as defined in the primary study at the final efficacy last visit of the primary study) 4. Parent(s) (preferably both if available or as per local requirements), legal guardian(s) or their legally acceptable representative must sign an 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 in protocol Appendix 3 (Section 10.3). 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 participate in the study. Please refer to study protocol section 5.1 for full list of inclusion criteria. |
| Key exclusion criteria | 1. Are pregnant, nursing, or planning pregnancy or fathering a child 2. 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: may be included with a documented negative result for a validated SARS-CoV-2 test 2.1. Obtained at least 2 weeks after conditions (a), (b), (c) above (timed from resolution of key clinical features if present, eg, fever, cough, dyspnea) AND 2.2. With absence of ALL conditions (a), (b), (c) above during the period between the negative test result and the baseline study visit NOTES on COVID-related exclusion: The field of COVID-related testing (for presence of, and immunity to, the SARS-CoV-2 virus) is rapidly evolving. Additional testing may be performed as part of screening and/or during the study if deemed necessary by the investigator and in accordance with current regulations/guidance from authorities/standards of care Precaution: for those who may carry a higher risk for severe COVID-19 illness, follow guidance from local health authorities when weighing the potential benefits and risks of enrolling in the study, and during participation in the study (protocol Appendix 8 [Section 10.8]). 3. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments 4. 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 SARS CoV-2 vaccine (against the virus that causes COVID-19) is not automatically an exclusion criterion and must be discussed with the medical monitor Please refer to study protocol section 5.2 for full list of exclusion criteria. |
| Date of first enrolment | 22/08/2021 |
| Date of final enrolment | 10/02/2026 |
Locations
Countries of recruitment
- Argentina
- Belgium
- England
- France
- Germany
- Hungary
- Italy
- Japan
- Poland
- Russian Federation
- Scotland
- Spain
- Türkiye
- United Kingdom
Study participating centres
London
E1 1FR
United Kingdom
Birmingham
B4 6NH
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
London
WC1N 3JH
United Kingdom
Sheffield
S10 2TH
United Kingdom
Southampton
SO16 6YD
United Kingdom
Sponsor information
Industry
Archimedesweg 29
Leiden
2333CM
Netherlands
| ClinicalTrialsEU@its.jnj.com | |
| Website | https://www.janssen.com/netherlands/ |
"ROR" |
https://ror.org/04cxegr21 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Janssen R&D, Janssen Research & Development, Janssen Research & Development, LLC, Janssen Research & Development LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Research & Development at Janssen, JRD, J&J PRD
- Location
- United States of America
Results and Publications
| Intention to publish date | 29/09/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Peer-reviewed scientific journals 2. Internal report 3. Conference presentation 4. Submission to regulatory authorities The results of the study will be available to the wider scientific community via publication in scientific journals and presentation at scientific meetings. Study results will be available to participants via provision of a Plain Language Summary at the end of the study and in addition results will be published in the EudraCT database. |
| IPD sharing plan | The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at https://www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through the Yale Open Data Access (YODA) Project site at https://yoda.yale.edu/. |
Editorial Notes
01/05/2025: The following updates were made:
1. Study contacts were updated.
2. Study Participating centres: Royal Hospital for Children and Young People and Bristol Royal Hospital for Children were removed. Great Ormond Street Hospital, Sheffield Childrens Hospital, and Southampton General Hospital were added.
15/02/2024: Contact details updated.
05/09/2023: Internal review.
09/08/2023: ISRCTN received notification of combined HRA/MHRA approval for this trial on 09/08/2023.
20/01/2023: Trial's existence confirmed by the HRA.
