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Juvenile psoriatic arthritis – Trials in Disease

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Ongoing Clinical Trials for Juvenile Psoriatic Arthritis

There are currently 6 clinical trials investigating new treatments for juvenile psoriatic arthritis across multiple European countries. These studies are testing various medications designed to reduce inflammation and improve joint symptoms in children and teenagers affected by this condition.

Clinical trial locations

Study on the Effects of Risankizumab and Adalimumab in Children with Active Juvenile Psoriatic Arthritis

This trial is evaluating risankizumab, a medication designed to reduce inflammation, in children aged 5 to under 18 years with active disease. The study compares risankizumab to adalimumab, which is already used to treat this condition. Both medications are administered as injections under the skin.

Main inclusion criteria: Participants must have been diagnosed with the condition for at least 6 months and have active disease in 3 or more joints at screening. They must have previously tried treatments such as methotrexate, sulfasalazine, leflunomide, or hydroxychloroquine, and found them either not effective or intolerable.

Main exclusion criteria: Children who have responded adequately to methotrexate or similar medications cannot participate. Those outside the age range of 5 to less than 18 years are also excluded, as are those without active disease.

Study focus: The primary goal is to evaluate whether participants achieve significant improvement in their arthritis symptoms by the 24th week. The study will also assess changes in pain levels, skin symptoms, and overall disease activity. The trial will last approximately 124 weeks, with regular check-ups to monitor progress and side effects.

Investigational drugs: Risankizumab works by targeting interleukin-23, a protein involved in inflammation. Adalimumab serves as the reference treatment and blocks tumor necrosis factor-alpha, another substance causing inflammation.

Study on the Long-term Safety of Guselkumab for Children with Crohn’s Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis

This long-term extension study focuses on evaluating the safety of guselkumab in children and teenagers who have previously participated in an initial study with this medication. The treatment is given as an injection under the skin using a pre-filled syringe.

Main inclusion criteria: Participants must have completed the planned treatment in the initial guselkumab study and shown improvement from continuing therapy. Parents or legal guardians must provide informed consent, and children capable of understanding must also agree to participate. Participants must be willing to follow lifestyle requirements and use appropriate birth control measures if applicable.

Main exclusion criteria: Children who are pregnant or breastfeeding cannot participate. Those with other medical conditions that might interfere with the study, recent participation in another clinical trial, or allergies to the study medication are also excluded.

Study focus: The main objective is to evaluate the long-term safety of guselkumab in pediatric participants. No primary or secondary endpoints will be collected, focusing solely on safety monitoring. The study is estimated to end in December 2031.

Investigational drug: Guselkumab is a monoclonal antibody that targets interleukin-23, a protein playing a role in inflammation. The study aims to understand how safe this medication is for children over an extended period.

Study on the Safety and Body Processing of Bimekizumab in Children with Juvenile Idiopathic Arthritis

This study examines bimekizumab in children with enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis. The medication is given as a solution for injection under the skin.

Main inclusion criteria: Participants must be between 2 and 17 years old and have a confirmed diagnosis for at least 6 months. They must have active disease, meaning at least 3 active joints and, for enthesitis-related arthritis, at least 1 site of inflammation where tendons or ligaments attach to bone. Participants must have had an inadequate response or intolerance to at least one nonsteroidal anti-inflammatory drug for at least 1 month. They must weigh at least 10 kg.

Main exclusion criteria: Patients with any other active autoimmune disease, serious infections in the past 3 months, or who received live vaccines within 4 weeks before the study cannot participate. Those with a history of cancer (except certain skin cancers), drug or alcohol abuse in the past year, or known allergies to the study medication are also excluded.

Study focus: The study aims to learn if bimekizumab is safe and how it moves throughout the body in children with these types of arthritis. Researchers will measure medication levels in the blood, monitor growth and vital signs, assess injection site reactions, and track any serious side effects. Response to treatment will be evaluated using specific criteria at week 16 and other timepoints.

Investigational drug: Bimekizumab is a monoclonal antibody that targets specific proteins involved in causing inflammation. By blocking these proteins, the medication aims to reduce symptoms such as pain and swelling.

Study of Ixekizumab and Adalimumab for Children with Juvenile Idiopathic Arthritis, Including Enthesitis-related Arthritis and Juvenile Psoriatic Arthritis

This trial evaluates ixekizumab compared to adalimumab in children with enthesitis-related arthritis and juvenile psoriatic arthritis. Both medications are administered through subcutaneous injection.

Main inclusion criteria: Participants must have active disease and weigh at least 10 kilograms. Children with juvenile psoriatic arthritis must be at least 2 years old, while those with enthesitis-related arthritis must be at least 6 years old. All immunizations must be up-to-date according to current guidelines.

Main exclusion criteria: Patients with arthritis types other than those being studied, those outside the specified age ranges, or those with other medical conditions that might interfere with the study cannot participate. Recent infections, participation in another clinical trial, pregnancy or breastfeeding, and allergic reactions to the study medication are also exclusionary.

Study focus: The primary goal is to assess the percentage of participants achieving a 30% improvement in symptoms, as defined by the Juvenile Idiopathic Arthritis American College of Rheumatology response criteria. The study will monitor efficacy, safety, and tolerability throughout the treatment period, with completion estimated by January 2029.

Investigational drugs: Ixekizumab targets and inhibits interleukin-17A, a protein involved in inflammation. Adalimumab serves as the reference treatment, blocking tumor necrosis factor-alpha to reduce inflammation.

Study on Long-term Safety of Ustekinumab for Children with Crohn’s Disease, Juvenile Psoriatic Arthritis, or Ulcerative Colitis

This extension study focuses on gathering information about the long-term safety of ustekinumab in young patients aged 2 to under 18 years who have already participated in a previous study with this medication. The medication is given as a solution for injection under the skin.

Main inclusion criteria: Participants must have completed the planned treatment in the initial pediatric ustekinumab study and shown benefit from continued therapy, such as clinical response or remission. Parents or legal guardians must sign an informed consent form, and children capable of understanding must also provide assent. Participants must be willing to follow lifestyle requirements specified in the study plan.

Main exclusion criteria: Patients with other serious health conditions that could interfere with the study, those who are pregnant or breastfeeding, or those who have had recent infections requiring antibiotic treatment cannot participate. Recent participation in another investigational drug study, severe allergic reactions to medications, and planned surgery during the study period are also exclusionary.

Study focus: The study will monitor any adverse events, serious adverse events, and injection site reactions. Regular clinical laboratory tests will be conducted to ensure safety, and participants’ conditions will be assessed to check for any worsening of disease. The study is estimated to end by December 2027.

Investigational drug: Ustekinumab is a monoclonal antibody that targets specific proteins in the immune system (interleukin-12 and interleukin-23) that can cause inflammation, helping to manage symptoms and improve quality of life.

Study on Ustekinumab and Guselkumab for Children with Active Juvenile Psoriatic Arthritis

This trial studies both ustekinumab and guselkumab in children and teenagers with active disease, evaluating how well these medications work, their safety, and how the body processes them. Both are administered as injections under the skin.

Main inclusion criteria: Participants must be between 5 and 17 years old and have a diagnosis that includes arthritis and psoriasis, or arthritis and at least two other specific features such as swelling of fingers or toes, nail pits, a family history of psoriasis, or a rash resembling psoriasis. They must have active disease in at least three joints and have shown inadequate response or intolerance to non-biologic disease-modifying drugs for at least 12 weeks or nonsteroidal anti-inflammatory drugs for at least 4 weeks.

Main exclusion criteria: Patients with other serious health conditions that could interfere with the study, those currently taking medications that might affect study results, or those with recent infections or illnesses cannot participate. Pregnant or breastfeeding patients, those with a history of allergic reactions to the study medications, and those unable to comply with study procedures are also excluded.

Study focus: The study monitors response to treatment and checks for side effects over a period of up to 52 weeks. Regular assessments occur at various intervals (Weeks 4, 8, 12, 16, 24, and 52) to track progress. The study also gathers data on the immune response to these medications and measures long-term effects on joint health.

Investigational drugs: Ustekinumab targets interleukin-12 and interleukin-23 proteins to reduce inflammation. Guselkumab works by blocking interleukin-23, also involved in the inflammatory response. Both are monoclonal antibodies designed to improve symptoms and quality of life for children with this type of arthritis.

Summary

The 6 ongoing clinical trials for juvenile psoriatic arthritis demonstrate a strong focus on biologic medications, specifically monoclonal antibodies that target different inflammatory proteins in the immune system. France, Germany, Spain, Italy, and Poland appear most frequently as trial locations, reflecting a concentration of pediatric rheumatology research infrastructure in these countries.

Several medications are being investigated, including risankizumab, guselkumab, bimekizumab, ixekizumab, and ustekinumab, all compared against or used alongside adalimumab, which serves as an established treatment reference. Two of the trials are long-term safety extension studies, highlighting the importance of understanding how these medications perform over extended periods in young patients.

Most trials require participants to have previously tried conventional treatments without adequate response, targeting children and teenagers who need alternative therapeutic options. The age ranges vary across studies, with some accepting children as young as 2 years old and others focusing on those aged 5 to 18 years. All studies emphasize safety monitoring alongside efficacy evaluation, recognizing the particular importance of careful assessment when treating pediatric populations.

Ongoing Clinical Trials on Juvenile psoriatic arthritis

  • Study on the Effects of Risankizumab and Adalimumab in Children with Active Juvenile Psoriatic Arthritis

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland Spain

  • Study on the Long-term Safety of Guselkumab for Children with Crohn’s Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy Norway Poland +2

  • Study on the Safety and Body Processing of Bimekizumab in Children with Juvenile Idiopathic Arthritis

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Poland Spain

  • Study of Ixekizumab and Adalimumab for Children with Juvenile Idiopathic Arthritis, Including Enthesitis-related Arthritis and Juvenile Psoriatic Arthritis

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Germany Italy The Netherlands +1

  • Study on Long-term Safety of Ustekinumab for Children with Crohn’s Disease, Juvenile Psoriatic Arthritis, or Ulcerative Colitis

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Hungary Italy Poland +1

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