At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Adalimumab (drug), Risankizumab (drug)
- How long the study runs
- Study runs about 51 months (dates as stated)
- About the drug or intervention
- Adalimumab — drug: SC Injection · Risankizumab — drug: Subcutaneous (SC) Injection
- Patient visit burden
- Not specified by the sponsor
In plain English
This study tests two medicines, risankizumab and adalimumab, in children with juvenile psoriatic arthritis (jPsA). Both medicines are given as an injection under the skin. Researchers will check for side effects, see whether the medicines change how active the arthritis is, and look at how the medicines move through the body. The study is run by AbbVie.
Who can take part
- Your child has had juvenile psoriatic arthritis for at least 3 months before screening, based on set rules from the International League of Associations for Rheumatology (ILAR).
- Your child's arthritis is active in 3 or more joints at screening and at the start of the study. This means the joints are swollen, or they cannot move fully and are painful, tender, or both.
- Your child's current or past arthritis medicine did not work well enough, or your child could not tolerate it. This must be at least one of these common medicines: methotrexate, sulfasalazine, leflunomide, or hydroxychloroquine. These are called conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).
Who may not be able to
- Your child has another autoimmune disease, another rheumatic disease, or an overlap syndrome. This includes other types of juvenile idiopathic arthritis (JIA), such as systemic JIA, polyarticular JIA, oligoarticular JIA, enthesitis-related arthritis, and undifferentiated JIA.
- Your child has not responded well enough in the past to medicines in the anti-tumour necrosis factor (anti-TNF) group or the interleukin-23 (IL-23) group.
What taking part involves
- • Receiving one of two study medicines, risankizumab or adalimumab, as an injection under the skin.
- • Checks for side effects.
- • Checks on how active the arthritis is.
- • Checks on how the medicine moves through the body.
Time commitment: Taking part means having injections under the skin; the number of visits, how long the study lasts, and how often injections are given are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 5 Years to 17 Years
- Who
- All
- Number of participants
- 40
- Started
- 2024-07-08
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for juvenile psoriatic arthritis
- • Phase3 - 40 participants
- • Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling
Who can take part?
- • Ages 5 Years to 17 Years
- • Diagnosed with juvenile psoriatic arthritis
Where?
- • Sheffield - Sheffield Children's Hospital NHS Foundation Trust /ID# 258848
- • Bristol - University Hospitals Bristol and Weston NHS Foundation Trust /ID# 258847
- • Liverpool - Alder Hey Children's NHS Foundation Trust /ID# 262770
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient's 16th birthday is called juvenile PsA (jPsA).This study will evaluate how safe risankizumab is for the treatment of psoriatic arthritis and to assess change in disease symptoms. Risankizumab is being studied for the treatment of jPsA and adalimumab is approved for the treatment of jPsA. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to receive adalimumab. Approximately 40 juvenile participants with jPsA will be enrolled at approximately 30 sites worldwide. Participants will receive risankizumab and adalimumab as subcutaneous (SC) injections based on body weight. At the start of Period 1, participants are randomized to receive risankizumab or adalimumab for 24 weeks. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study. Participants who receive adalimumab are followed for safety for 70 days after the last study treatment. Participants who receive risankizumab are followed for 140 days after the last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 5 Years - 17 Years
- Who can join: All genders
What the study is looking for
- ✓Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology...
- ✓Active Disease in \>= 3 joints at screening and at Baseline (swelling not due to deformity, or limitation of motion...
Who cannot take part
- ✗Prior inadequate response to treatments in the anti-TNF or IL-23 inhibitor classes.
See the full criteria
Where Is This Study? (3 UK sites)
Sheffield Children's Hospital NHS Foundation Trust /ID# 258848
Sheffield S10 2TH, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust /ID# 258847
Bristol BS2 8BJ, United Kingdom
Alder Hey Children's NHS Foundation Trust /ID# 262770
Liverpool L12 2AP, United Kingdom
How to Get in Touch
ABBVIE CALL CENTER
Sponsor contactCONTACT