RecruitingPHASE3INTERVENTIONAL

Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

This research study is investigating a new oral medication called apremilast for children and young people aged 5 to 17 years who are living with active juvenile psoriatic arthritis (JPsA). JPsA is a condition where young people have both psoriasis (a skin condition) and arthritis (joint inflammation). The main goal is to find out how effective apremilast is compared to a 'dummy' pill (placebo) in helping to improve their arthritis symptoms. Participants will be closely monitored to see if the new medicine provides real benefits. This type of study, known as apremilast, a 'Phase 3' trial, is an important step in determining if a new treatment is safe and effective enough to be considered for wider use, especially when other treatments haven't worked well or caused problems.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Amgen

Enrolment target

Start

17 Mar 2022

Estimated completion

29 Dec 2028

Active Juvenile Psoriatic Arthritis

What is this study about?

This research study is focused on children and young people aged 5 to 17 who have a condition called juvenile psoriatic arthritis (JPsA). JPsA is a type of arthritis that affects young people and is often linked to psoriasis, a skin condition that causes red, scaly patches. In JPsA, the immune system mistakenly attacks healthy joints, leading to pain, swelling, and stiffness. This study is testing a medication called apremilast to see if it can help reduce these symptoms and improve the lives of young people with JPsA.

The study aims to compare apremilast with a 'placebo' – which is a dummy pill that looks just like the real medicine but contains no active drug. By comparing the effects of apremilast to a placebo, researchers can get a clear idea of whether the medicine itself is causing any improvements. This is a common and important way to test new treatments fairly.

This is a 'Phase 3' study, which means it's one of the final stages of testing a new medicine before it might be considered for wider use. It's a key step in understanding if apremilast is both safe and effective for treating juvenile psoriatic arthritis in this age group, particularly when other treatments haven't been successful or have caused side effects for patients.

Key takeaways

Tests a new medicine (apremilast) for children and young people with active juvenile psoriatic arthritis (JPsA).
Compares apremilast to a dummy pill (placebo) to see how well it works.
For those aged 5 to 17 who haven't improved with other treatments.
Requires regular clinic visits and careful monitoring.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, children and young people need to be between 5 and under 18 years old. They must have a confirmed diagnosis of juvenile psoriatic arthritis that they've had for at least 6 months. This diagnosis means they either have both arthritis and psoriasis, or arthritis plus at least two other signs like swollen fingers or toes, changes in their nails, or a close family member who has psoriasis. Critically, their arthritis must currently be active, meaning at least three of their joints are still affected. They also need to have tried and not responded well to, or had problems with, at least one other arthritis medication (like methotrexate or biologic drugs) for at least two months.

There are also some reasons why someone might not be able to join. For example, if they have other specific types of arthritis that are not psoriatic arthritis, or other serious health conditions beyond JPsA, they would not be eligible. This includes conditions like lupus, fibromyalgia, or certain types of inflammatory joint disease.

Quick self-check

Is your child aged between 5 and 17 years?
Does your child have a confirmed diagnosis of juvenile psoriatic arthritis for at least 6 months?
Does your child currently have at least three active, painful or swollen joints?
Has your child tried at least one other arthritis medicine with limited success or side effects?
Does your child NOT have other specific types of arthritis or certain other serious health conditions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, your child would receive either the study medicine (apremilast) or a dummy pill (placebo). You wouldn't know which one they are getting until the end of the study. Your child would need to attend regular clinic visits where doctors and nurses would monitor their progress, check their symptoms, and make sure they are feeling well. These visits would likely include physical examinations, blood tests, and discussions about how your child is doing. The full length of the study, including the different treatment and follow-up periods, would be explained to you in detail by the study team. They will ensure you understand what each visit involves and how long your child would be participating overall.

Potential risks and benefits

Taking part in a clinical study could offer potential benefits, such as receiving a new treatment that might improve your child's condition, as well as close medical monitoring and care. However, there are also potential risks, including possible side effects from the study medication, or the chance that the dummy pill may not improve their condition. All potential side effects will be fully explained before you agree to participate. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (45)

Landeskrankenhaus Bregenz
Bregenz, Austria· Recruiting
Universitair Ziekenhuis Gent
Ghent, Belgium· Terminated
Centre Hospitalier Regional de la Citadelle
Liège, Belgium· Terminated
Ziekenhuis Netwerk Antwerpen Jan Palfijn
Merksem, Belgium· Terminated
Hospices Civils de Lyon Hopital Femme Mere Enfant
Bron, France· Recruiting
Hopital Jeanne de Flandre
Lille, France· Recruiting
Charite - Universitaetsmedizin Berlin, Campus Virchow
Berlin, Germany· Recruiting
Universitaetsklinikum Dresden
Dresden, Germany· Recruiting
An der Schoen Klinik Hamburg Eilbek
Hamburg, Germany· Recruiting
Asklepios Kinderklinik Sankt Augustin GmbH
Sankt Augustin, Germany· Completed
Agia Sofia Children Hospital
Athens, Greece· Recruiting
Attikon University General Hospital
Athens, Greece· Recruiting

+33 more sites — see the official record for the full list.

Common questions

What is juvenile psoriatic arthritis (JPsA)?

JPsA is a type of arthritis that affects children and young people, often linked to a skin condition called psoriasis. It causes joint pain, swelling, and stiffness.

What is apremilast?

Apremilast is a medicine being tested. It's designed to help reduce inflammation in the body that causes conditions like arthritis.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the study medicine but doesn't contain any active drug. It helps researchers see if the real medicine is truly effective.

Why is this study important?

This study aims to find out if apremilast can be a safe and effective new treatment option for children and young people with JPsA who haven't responded well to other medicines.

Will my child definitely get the new medicine?

No, your child will either receive the study medicine (apremilast) or a placebo. You won't know which one they are getting during the study.

How to find out more

Amgen Call Center

medinfo@amgen.com 866-572-6436 Official trial record

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