Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Liliane Tchokouassoum Siewe
+49 69506027192
liliane.siewe@iqvia.com


Dr Sandrine Lacassagne
+44 20 7829 7899
Sandrine.Lacassagne@gosh.nhs.uk


Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Study to evaluate the efficacy, pharmacokinetics, safety, and immunogenicity of subcutaneously administered ustekinumab or guselkumab in pediatric participants with active juvenile psoriatic arthritis
Back

Study to evaluate the efficacy, pharmacokinetics, safety, and immunogenicity of subcutaneously administered ustekinumab or guselkumab in pediatric participants with active juvenile psoriatic arthritis

Recruiting

Open to: All Genders

Age: Child

$location.addressLine3

Medical Conditions

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.


Juvenile psoriatic arthritis (jPsA) is a type of arthritis that affects children and is characterized by severe joint inflammation (irritation and swelling) which can last for months and years.

Ustekinumab (study drug) is a medicine that binds to both human interleukin (IL)-12 and IL-23 and guselkumab binds to IL-23 and blocks its activity. By blocking the effects of IL-12 and/or IL-23, inflammation is reduced thus preventing disease from getting worse.

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:

27 Oct 2021 31 Mar 2026

This study will include:
1. Screening period (up to 6 weeks)
2. Treatment period (up to 52 weeks):
• Cohort 1: Participants will receive a weight-based dose of ustekinumab subcutaneously* (SC) at Week 0, Week 4 and then every 12 weeks up to Week 52.
• Cohort 2: Participants will receive guselkumab SC at Weeks 0 and 4 followed by either every 4 weeks (Q4W) (with historical radiographic evidence of joint damage) or every 8 weeks (Q8W) (without historical evidence of joint damage) dosing with the last dose at Week 52. Participants at high risk of joint damage can also be considered for Q4W dosing per investigator.
*Under the skin.
3. Safety follow-up period (at Week 68)
4. Long-Term Extension (LTE): Participants in both ustekinumab and guselkumab cohorts who complete the Week 52 evaluations, will have the option to enter a separate ustekinumab (CNTO1275ISD3001) or guselkumab (CNTO1959ISD3001) LTE study at Week
52, if the entry criteria for LTE are met.

Participants will undergo study assessments and tests, such as joint and skin exams, blood tests and questionnaires. Blood samples will be taken at multiple timepoints to understand how the body responds to treatment. All side effects will be recorded till study ends.

The overall duration of this study will be up to 1 year 4 months.


This study will include participants of 5 to <18 years with active jPsA.

You can take part if:



You may not be able to take part if:


1. Participants with enthesitis-related arthritis (ERA)2. Taken any disallowed therapies as noted in Section 6.8, Concomitant Therapy within the timeframe specified before the planned first dose of study intervention.3. If participants were non-responders to previously received biologic treatment with an overlapping mechanism including guselkumab, ustekinumab, tildrakizumab (MK3222) and risankizumab (BI-655066). Prior non-response to an anti-TNFα inhibitor, an IL-17 inhibitor or a Janus kinase (JAK) inhibitor is not an exclusion. Patients who previously discontinued ustekinumab for intolerance may be enrolled into the guselkumab cohort. Patients who previously discontinued guselkumab due to intolerance may be enrolled into the ustekinumab cohort.4. Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 4 weeks or 5 half-lives (whichever is longer) before the planned first dose of either study intervention or is currently enrolled in an investigational study. Receipt of an investigational vaccine for COVID-19 is not an automatic exclusion criterion; discuss with medical monitor.5. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening. An exception is made for participants currently receiving treatment for latent TB with no evidence of active TB, or who have a history of latent TB and documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of either study intervention (Section 5.1, Inclusion criterion 16.a of the study protocol).


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

  • -
    -

There is no established benefit to participants of this study. Based on scientific theory, administering ustekinumab and/or guselkumab to a patient may improve juvenile psoriatic arthritis (jPsA). However, this cannot be guaranteed because ustekinumab and guselkumab are
still under investigation as treatment and it is not known whether ustekinumab or guselkumab 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 jPsA 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 clinical worsening of jPsA, serious infection, hypersensitivity reaction including serious hypersensitivity reaction, malignancy, immunosuppression, liver injury (only for guselkumab) after getting the study drug. The participant information sheet and informed consent form, which will be signed by every
participant agreeing to participate in the study, includes a detailed section outlining the known risks to participating in the study.
Not all possible side effects and risks related to ustekinumab and guselkumab are known at this moment. During the study, the sponsor may learn new information about ustekinumab and guselkumab. The study doctor will tell participants as soon as possible about any new information that might make them change their mind about being in the study, such as new risks.
To minimize the risk associated with taking part in the study, participants are frequently assessed for any side effects and other medical events. Participants are educated to report any such events to the study doctor who will provide appropriate medical care.
Any serious side effects that are reported to the sponsor are thoroughly reviewed by a specialist drug safety team.
There are no costs to participants to be in the study. The sponsor will pay for the study drug and tests that are part of the study. The participant will receive reasonable reimbursement for study-related costs (e.g., travel/parking costs).

Dr Liliane Tchokouassoum Siewe
+49 69506027192
liliane.siewe@iqvia.com


Dr Sandrine Lacassagne
+44 20 7829 7899
Sandrine.Lacassagne@gosh.nhs.uk



The study is sponsored by Janssen-Cilag International NV and funded by Janssen-Cilag International NV.




We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: ISRCTN49107623

Or CPMS 53232

Last updated 02 November 2023

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top