RecruitingPhase IIIInterventional

A long-term extension (LTE) study of guselkumab in pediatric participants

This study is checking the long-term safety of a medicine called guselkumab in children and young people aged 2-17. It's for those who have moderately to severely active ulcerative colitis, Crohn's disease, or juvenile psoriatic arthritis. These conditions cause inflammation and pain in the gut or joints, and can also cause skin rashes or ulcers. Guselkumab works by blocking a specific protein in the body that causes inflammation. This study aims to see how safe this medicine is over a longer period for participants who have already found it helpful in a previous trial. Participants will continue to receive guselkumab, with regular check-ups to monitor their health and any side effects.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Janssen-Cilag International NV

Enrolment target

196

Start

20 Oct 2024

Estimated completion

05 Jun 2028

Moderately to severely active ulcerative colitis (UC), moderately to severely active Crohn's disease (CD), Juvenile psoriatic arthritis (jPsA)

What is this study about?

This study is all about understanding how safe a medicine called guselkumab is when given over a longer time to children and young people. This medication is for those who have already been taking it in a different study and have found it helpful for conditions like ulcerative colitis (UC), Crohn's disease (CD), or juvenile psoriatic arthritis (jPsA). UC and CD are conditions where parts of the digestive system become inflamed and can develop sores. Juvenile psoriatic arthritis is a type of arthritis in young people that causes joint pain and swelling, often with a skin rash.

Guselkumab works by targeting a specific protein in the body that causes inflammation. By blocking this protein, the medicine aims to reduce the inflammation and symptoms of these conditions. Since guselkumab is still being studied for these uses, this particular trial is important to gather more information on its safety when used for several years.

Taking part in this study means you would continue to receive guselkumab, and your health would be closely monitored by a medical team. This helps them understand any effects the medicine might have, both good and bad, over time. The information gathered from this study will help doctors and researchers learn more about guselkumab, potentially helping many more children and young people with these conditions in the future.

Key takeaways

This study is for children and young people (2-17 years old) with specific gut or joint conditions.
It's an extension study, meaning you must have already used guselkumab in a previous trial and found it helpful.
The main goal is to safely continue giving guselkumab and see how it affects health over a longer period.
You will receive regular check-ups and medical care, with no cost to you.
There are known side effects, but you will be closely monitored, and new information will be shared.

Who may be eligible?

This study is specifically designed for children and young people between 2 and 17 years old. You could be eligible if you have moderately to severely active ulcerative colitis, Crohn's disease, or juvenile psoriatic arthritis.

Importantly, to join this study, you must have already taken part in one of the previous guselkumab studies for these conditions and your doctor believes that guselkumab has been beneficial for you and you continue to need it. Your doctor will make the final decision on whether you are suitable.

There are also some requirements regarding birth control or donating eggs/sperm, if applicable, to ensure safety during the study. If you're a parent, both you and your child will need to agree to take part after fully understanding the study. If your child is old enough (usually 7 years or older), they will also need to give their agreement.

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.

Are you between 2 and 17 years old?
Do you have ulcerative colitis, Crohn's disease, or juvenile psoriatic arthritis?
Have you already been in a guselkumab study for one of these conditions?
Does your current doctor believe guselkumab is helping you?
Are you able to follow specific guidelines about birth control or donating eggs/sperm, if they apply to you?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will continue to receive guselkumab, the same medicine you were given in the previous study. The medicine will be given either every 8 weeks or every 4 weeks, depending on what you were receiving before. Your doctor might be able to change how often you receive the medicine in some cases, but generally, the dosing schedule will stay the same.

Throughout the study, your health will be carefully checked. This involves regular appointments where you'll have blood tests, physical examinations, and your vital signs (like heart rate and blood pressure) checked. Doctors will also watch out for any signs of suicidal thoughts or behaviours and other side effects. All possible side effects will be recorded until the study finishes. The study is expected to last about 7 years. You will receive regular check-ups and medical care from the study team. There are no costs for participating, and the study will cover the cost of the medicine and tests. You'll also be paid back for reasonable travel costs, such as parking.

Potential risks and benefits

While there's no guarantee that participating will directly benefit you, some people feel better just by having their health monitored so closely. The information from this study will also be very valuable in helping other children and young people with these conditions in the future. However, it's important to know that all medicines can have side effects. With guselkumab, common side effects can include infections (like colds or sore throats), headaches, joint pain, tummy upset, or skin rashes. More serious but less common risks include severe infections, certain types of cancer, allergic reactions, reactions where you get the injection, or liver problems. Not all possible side effects are known yet, but you will be closely monitored, and the study doctor will tell you immediately about any new risks that come to light. You can stop taking part in the study at any time.

Locations (1)

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Approximate
-, England

Common questions

What is guselkumab and what does it do?

Guselkumab is a medicine that helps reduce inflammation in the body. It works by blocking a specific protein involved in causing inflammation, which can help people with conditions like ulcerative colitis, Crohn's disease, and juvenile psoriatic arthritis.

Who is funding this study?

This study is funded by Janssen-Cilag International NV, a pharmaceutical company.

Will I have to pay anything to be in the study?

No, you won't have to pay anything. The study will cover the cost of the medicine and any tests you need, and you'll be reimbursed for things like travel expenses.

Can I stop being part of the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason. Your doctor and the study team will support you.

How long will I be in this study?

The study is expected to run for about 7 years, but your individual participation will be discussed with the study team.

How to find out more

Jack Alden

JanssenUKRegistryQueries@its.jnj.com +44 7345 062227 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.