Active not recruitingOBSERVATIONAL

A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis

This research study aims to understand the long-term safety of a treatment called ustekinumab when used in children and teenagers (aged 6 to 17) who have moderate to severe plaque psoriasis. The main goal is to carefully watch for any serious side effects that might be linked to how the medication affects the immune system, such as severe infections, certain types of cancers, or autoimmune conditions. Researchers will also be tracking how ustekinumab might affect a child's growth (their weight, height, and body mass index) and their development, including sexual maturity. This helps us get a clearer picture of the medication's overall profile for younger patients over time.

At a glance

Status

Active not recruiting

Sponsor

Janssen-Cilag International NV

Enrolment target

135

Start

25 Oct 2017

Estimated completion

31 Aug 2032

Psoriasis

What is this study about?

This study is designed to gather more information about a medicine called ustekinumab, which is used to treat a skin condition called plaque psoriasis. Psoriasis can be quite challenging, especially for children and teenagers, and ustekinumab is one of the treatments available.

The main purpose of this study is to closely monitor the long-term safety of ustekinumab in young people aged 6 to 17 years old who have moderate to severe plaque psoriasis. Researchers are particularly interested in seeing if there are any long-term effects on the immune system, such as a higher risk of serious infections, certain cancers, or conditions where the immune system mistakenly attacks healthy parts of the body (autoimmune conditions).

Beyond immune system effects, the study will also track important aspects of a child's well-being, like their growth (height, weight, and body mass index) and how they develop sexually. This is crucial because children and teenagers are still growing and changing, and it's important to understand how medications might affect these processes. This study helps healthcare professionals and families make informed decisions about psoriasis treatment for younger patients.

Key takeaways

This study focuses on the long-term safety of ustekinumab for children and teenagers with psoriasis.
Researchers will monitor for serious infections, cancers, and autoimmune issues.
The study also tracks the medication's effects on growth and development.
Participants will already be taking ustekinumab for their condition.
Participation involves ongoing health monitoring and completing questionnaires.
You can withdraw your child from the study at any time.

Who may be eligible?

To join this study, a child or teenager must have been diagnosed with moderate to severe chronic plaque psoriasis. They should either be starting ustekinumab treatment for their psoriasis within two months of joining the study, or they might have already started this treatment in the three months before the study began. The decision to use ustekinumab must have been made by their doctor independently, before deciding to participate in this study.

It's important that the participant (and their parent or guardian, if applicable) agrees to take part and can understand and complete any questionnaires about their health and how they are feeling. This includes giving permission for their health information to be collected and checked.

Children or teenagers cannot take part if they are already involved in another clinical study where they are receiving an experimental treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 6 and 17?
Does your child have a confirmed diagnosis of moderate to severe plaque psoriasis?
Is your child just starting ustekinumab or has started it in the last 3 months?
Are you and your child willing to sign a consent form and complete occasional questionnaires?
Is your child NOT currently taking part in another experimental medical study?

Answer every question to see your result.

What does participation involve?

This study will primarily involve monitoring your child's health over time. This means attending regular appointments where healthcare professionals will check for any serious infections, changes in their immune system, or other health issues. They will also measure your child's growth, including their height, weight, and body mass index. In addition, they will assess your child's stage of sexual development. You and your child will be asked to complete questionnaires about your child's health and how their psoriasis affects their daily life. The total duration of the study is not specified, but it focuses on long-term monitoring, which typically means several years of follow-up.

Potential risks and benefits

Participating in this study will help us learn more about the long-term safety of ustekinumab in young people, which could benefit others with psoriasis in the future. While individual benefits are not guaranteed, receiving careful medical monitoring is part of the study. Potential risks include those associated with ustekinumab treatment itself, such as side effects like infections, and the possibility of discovering new risks as part of the long-term monitoring. There are also risks associated with data privacy, though all efforts will be made to keep your child's information confidential. You are free to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (30)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Uniklinik Graz
Verified postcode
Graz, Austria
UCL Hopital Saint-Luc
Verified postcode
Brussels, Belgium
UZ Leuven
Verified postcode
Leuven, Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman
Verified postcode
Liège, Belgium
Grand Hôpital de Charleroi
Verified postcode
Loverval, Belgium
Bispebjerg Hospital
Verified postcode
Copenhagen, Denmark
Gentofte Herlev Hospital
Verified postcode
Hellerup, Denmark
CH Victor Dupouy Argenteuil
Verified postcode
Argenteuil, France
CHRU Besancon Hopital Jean Minjoz
Verified postcode
Besançon, France
Groupe Hospitalier Pellegrin CHU de Bordeaux
Verified postcode
Bordeaux, France
ICH Hopital A. Morvan
Verified postcode
Brest, France
Le Bateau Blanc
Verified postcode
Martigues, France

Common questions

What is ustekinumab?

Ustekinumab is a medicine used to treat moderate to severe plaque psoriasis by targeting specific parts of the immune system.

Who can join this study?

Children and teenagers aged 6 to 17 with moderate to severe plaque psoriasis who are starting or have recently started ustekinumab can join.

What will researchers be looking for?

They will monitor for serious infections, cancers, autoimmune conditions, and track how the medicine affects growth and development.

Will my child get a new treatment in this study?

No, this study is about monitoring the long-term safety of ustekinumab, which your child would already be taking for psoriasis, not starting a new or experimental treatment.

Can I withdraw my child from the study?

Yes, you can withdraw your child from the study at any time without it affecting their medical care.