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Dr Medical Information -
+44(0)800 7318450
medinfo@its.jnj.com


Dr Robert Heuschkel


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Be Part of Research - Trial Details - A long-term extension study of ustekinumab in pediatric participants with different medical conditions
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A long-term extension study of ustekinumab in pediatric participants with different medical conditions

Recruiting

Open to: All Genders

Age: Child

Southampton Cambridge London London Sheffield Birmingham

Medical Conditions

Moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis, juvenile psoriatic arthritis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

22 Aug 2021 10 Feb 2026

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.


Participants who successfully completed one of four primary studies, aged 2 – 17 years old

You can take part if:



You may not be able to take part if:


1. Are pregnant, nursing, or planning pregnancy or fathering a child2. 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 test2.1. Obtained at least 2 weeks after conditions (a), (b), (c) above (timed from resolution of key clinical features if present, eg, fever, cough, dyspnea)AND2.2. With absence of ALL conditions (a), (b), (c) above during the period between the negative test result and the baseline study visitNOTES 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 carePrecaution: 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.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Southampton General Hospital
    Tremona Road
    Southampton
    SO16 6YD
  • Addenbrookes
    Addenbrookes Hospital Hills Road
    Cambridge
    CB2 0QQ
  • Great Ormond Street Hospital
    Great Ormond Street
    London
    WC1N 3JH
  • Royal London Hospital
    Whitechapel Road
    London
    E1 1FR
  • Sheffield Childrens Hospital
    Western Bank
    Sheffield
    S10 2TH
  • Birmingham Children's Hospital
    Steelhouse Lane
    Birmingham
    B4 6NH

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.

Dr Medical Information -
+44(0)800 7318450
medinfo@its.jnj.com


Dr Robert Heuschkel



The study is sponsored by Janssen (Netherlands) and funded by Janssen Research and Development.



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Read full details for Trial ID: ISRCTN36985527

Or CPMS 52012

Last updated 01 May 2025

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