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RecruitingPHASE3INTERVENTIONAL

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

This study is for children and teenagers aged 5 to 17 who have a medical condition called juvenile psoriatic arthritis (jPsA). This condition causes joint pain, swelling, and stiffness because the body's immune system mistakenly attacks healthy tissues. The study wants to find out how safe and effective a new medicine, risankizumab, is in treating jPsA, comparing it to an existing medicine, adalimumab. Both medicines are given as injections under the skin. Participants will be split into two groups, each receiving one of the medicines. The study will monitor changes in their jPsA symptoms and check for any side effects over a long period, potentially several years. Taking part involves regular hospital or clinic visits for check-ups and tests.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
AbbVie
Enrolment target
40
Start
08 Jul 2024
Estimated completion
01 Oct 2028

What is this study about?

This study is looking into a new medicine called risankizumab for children and teenagers who have juvenile psoriatic arthritis (jPsA). jPsA is a type of arthritis that starts before someone turns 16. It happens when the body's defence system, called the immune system, starts attacking healthy parts of the body, leading to joint pain, swelling, and stiffness. We sometimes call this an 'autoimmune' condition. Currently, another medicine called adalimumab is approved to treat jPsA, and this study aims to see how risankizumab compares.

The main goal of this research is to understand how safe risankizumab is for young people with jPsA and how well it helps to improve their symptoms. The study will also look at how the medicine moves through the body. By comparing it to an existing treatment, researchers hope to see if risankizumab could be another helpful option for children and teenagers living with jPsA.

Finding new and effective treatments is really important for young people with jPsA to help manage their symptoms, improve their quality of life, and reduce the long-term impact of the condition. This study is a 'Phase 3' trial, which means the medicine has already gone through earlier safety tests and is now being tested in a larger group of people to confirm its safety and effectiveness.

Key takeaways

  • A study for children/teens (5-17) with juvenile psoriatic arthritis (jPsA).
  • Compares two injected medicines: new risankizumab vs. existing adalimumab.
  • Aims to check safety and how well medicines improve jPsA symptoms.
  • Participation involves regular clinic visits, blood tests, and questionnaires.
  • Could be a long study, potentially over two years for some participants.

Who may be eligible?

To be considered for this study, children and teenagers generally need to be between 5 and 17 years old and have a confirmed diagnosis of juvenile psoriatic arthritis (jPsA) for at least three months. Importantly, their jPsA must currently be 'active', meaning they have swelling, pain, or tenderness in at least three of their joints.

Also, a key requirement is that a previous standard medicine for jPsA, such as methotrexate, sulfasalazine, leflunomide, or hydroxychloroquine, hasn't worked well enough for them, or they couldn't tolerate it. This helps ensure the study is looking at new options for those who might need them.

However, some conditions would mean someone couldn't join. For example, if they have other autoimmune conditions (like lupus or other types of juvenile arthritis), or if they haven't responded well to certain groups of medicines in the past, they might not be able to participate.

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.

  1. Are you between 5 and 17 years old?
  2. Have you been diagnosed with juvenile psoriatic arthritis (jPsA) for at least 3 months?
  3. Do you currently have active jPsA with at least three painful or swollen joints?
  4. Has a previous jPsA medicine (like methotrexate) not worked well for you or caused problems?
  5. Do you have any other types of autoimmune or rheumatic diseases?
  6. Have you previously tried and not responded to 'anti-TNF' or 'IL-23 inhibitor' medicines?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of two groups by chance, like flipping a coin. One group will receive risankizumab, and the other will receive adalimumab. There's a 1 in 4 chance you'd receive adalimumab. Both medicines are given as injections under the skin, with the dose adjusted based on body weight.

Initially, for 24 weeks, you'll receive your assigned treatment. If your jPsA improves during this period, you could continue on the same treatment for a much longer time – potentially another 100 weeks. If your jPsA gets worse during this longer period, you would stop taking the study medicine.

Taking part involves regular visits to a hospital or clinic. These visits will include check-ups by doctors, blood tests, and discussions about any side effects you might be experiencing. You'll also be asked to fill in questionnaires about how you're feeling and how your jPsA is affecting you. After your last dose of the study medicine, you'll be followed closely for safety for a period of either 70 days (if you received adalimumab) or 140 days (if you received risankizumab). This is to make sure any late side effects are noted. Because of all these checks and visits, taking part might mean more appointments than your usual care.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as receiving a new or existing treatment for your juvenile psoriatic arthritis that might help improve your symptoms. You will also receive very close medical attention and monitoring throughout the study. However, there are potential risks too, as with any medicine. Both risankizumab and adalimumab can have side effects, which will be carefully monitored by the study team. There might also be discomfort from injections and blood tests. It's important to remember that the new medicine might not work for everyone, and it's also possible that your condition might not improve or could even worsen. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (32)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Arkansas Children's Hospital /ID# 258776
    Verified postcode
    Little Rock, United States· Recruiting
  • Childrens National Medical Center /ID# 259284
    Verified postcode
    Washington D.C., United States· Recruiting
  • Joe Dimaggio Children's Hospital Hollywood /ID# 260634
    Verified postcode
    Hollywood, United States· Recruiting
  • Indiana University Health Riley Hospital for Children /ID# 259067
    Verified postcode
    Indianapolis, United States· Recruiting
  • M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111
    Verified postcode
    Minneapolis, United States· Recruiting
  • Columbia University Medical Center /ID# 262587
    Verified postcode
    New York, United States· Recruiting
  • Boston Childrens Health Physicians /ID# 258061
    Verified postcode
    Valhalla, United States· Recruiting
  • University of North Carolina - Children's Hospital /ID# 259286
    Verified postcode
    Chapel Hill, United States· Recruiting
  • MetroHealth Medical Center /ID# 262377
    Verified postcode
    Cleveland, United States· Recruiting
  • Child Neurology Consultants of Austin /ID# 260562
    Verified postcode
    Austin, United States· Recruiting
  • Monash Health - Monash Medical Centre /ID# 260255
    Verified postcode
    Clayton, Australia· Recruiting
  • Alberta Children's Hospital /ID# 257880
    Verified postcode
    Calgary, Canada· Recruiting

Common questions

What is juvenile psoriatic arthritis (jPsA)?

It's a type of arthritis in young people where the body's immune system attacks healthy joints, causing pain, swelling, and stiffness.

What medicines are being tested?

The study is testing a new medicine called risankizumab, comparing it to an existing medicine called adalimumab. Both are given as injections.

How old do I need to be to join?

Participants need to be between 5 and 17 years old.

How long will the study last?

Initially 24 weeks, but if your jPsA improves, you could continue on the study medicine for up to another 100 weeks, followed by a safety check-up period.

Will I have more hospital visits than usual?

Yes, taking part typically involves more regular hospital or clinic visits than your standard care for check-ups and tests.

How to find out more

ABBVIE CALL CENTER

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Assess Adverse Events, Change in Disease Activity…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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