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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of two medications, Ustekinumab and Guselkumab, in children and teenagers with Juvenile Psoriatic Arthritis. Juvenile Psoriatic Arthritis is a type of arthritis that affects children and is associated with the skin condition psoriasis, which causes red, scaly patches on the skin. The purpose of the study is to evaluate how well these medications work, how safe they are, and how the body processes them when given as an injection under the skin.

Participants in the study will receive either Ustekinumab or Guselkumab over a period of up to 52 weeks. The study will monitor the participants' response to the treatment, including any changes in their arthritis symptoms and any side effects they may experience. The study will also look at how the body absorbs and breaks down the medications, which is known as pharmacokinetics. This information will help determine the best dosage and frequency for these medications in treating Juvenile Psoriatic Arthritis.

Throughout the study, participants will have regular check-ups to assess their health and the effectiveness of the treatment. The study aims to provide valuable information on the use of Ustekinumab and Guselkumab in young patients with Juvenile Psoriatic Arthritis, potentially leading to better treatment options for managing this condition. The study will also gather data on the immune response to these medications, which is important for understanding their long-term safety and effectiveness.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age between 5 and 18 years and a diagnosis of juvenile psoriatic arthritis.

    The assessment checks for active disease in at least three joints and previous treatment history with non-biologic DMARDs or NSAIDs.

  2. Step 2

    Medication administration

    Participants receive either ustekinumab or guselkumab through subcutaneous injections. The specific medication and dosage depend on the study group assignment.

    Ustekinumab is administered as a 45 mg or 90 mg solution, while guselkumab is provided as a 100 mg/mL solution.

  3. Step 3

    Treatment schedule

    The treatment involves regular injections over a specified period. Ustekinumab is given every 12 weeks, while guselkumab is administered every 4 or 8 weeks.

    The schedule is designed to maintain steady levels of the medication in the body.

  4. Step 4

    Monitoring and evaluation

    Participants undergo regular monitoring to evaluate the effectiveness and safety of the treatment. This includes measuring the response to treatment and checking for any side effects.

    Assessments occur at various intervals, such as Weeks 4, 8, 12, 16, 24, and 52, to track progress and adjust treatment if necessary.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment is conducted to evaluate the overall outcomes of the treatment.

    This includes measuring the long-term effects on joint health and any potential development of antibodies against the medications.

Who can join the trial?

5 criteria

  • Must be between 5 and 17 years old.
  • Must have a diagnosis of juvenile psoriatic arthritis (jPsA). This means having arthritis and psoriasis, or arthritis and at least two of the following: dactylitis (swelling of fingers or toes), nail pits (small dents in the nails), a family history of psoriasis, or a rash that looks like psoriasis.
  • Must have active disease in at least three joints. This means the joints are swollen or have limited movement with pain or tenderness.
  • Must have active disease even after trying non-biologic DMARD (disease-modifying antirheumatic drugs) for at least 12 weeks or showing intolerance, and/or NSAID (non-steroidal anti-inflammatory drugs) for at least 4 weeks or showing intolerance.
  • If previously treated with an anti-TNFα agent (a type of medication for inflammation) or other biologic agents, these should have been stopped before starting the study, following specific guidelines for how long to wait after stopping the medication.

Who cannot join the trial?

8 criteria

  • Patients who have any other serious health conditions that could interfere with the study.
  • Patients who are currently taking medications that might affect the study results.
  • Patients who have had a recent infection or illness that could impact their participation.
  • Patients who have a history of allergic reactions to the study medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a history of substance abuse.
  • Patients who are unable to comply with the study procedures.
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Investigated drugs

  • Ustekinumab

    is a medication used in this trial to treat children with active juvenile psoriatic arthritis. It works by targeting specific proteins in the immune system that contribute to inflammation and the symptoms of arthritis. The goal is to reduce joint pain and swelling, improve physical function, and slow down joint damage.

  • Guselkumab

    is another medication being tested in the trial for its effectiveness in treating juvenile psoriatic arthritis. Like ustekinumab, it targets certain proteins in the immune system to help reduce inflammation and alleviate the symptoms associated with the condition. The study aims to assess how well it works in improving the health and quality of life for children with this type of arthritis.

What is already known about the treatment

  • Ustekinumab

    Ustekinumab is administered through subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating juvenile psoriatic arthritis. It is a well-established medication in medical literature, primarily used for conditions like psoriasis and psoriatic arthritis. The main therapeutic indication for ustekinumab is to reduce inflammation and alleviate symptoms associated with autoimmune conditions. At the molecular level, it works by targeting and inhibiting specific proteins, interleukin-12 and interleukin-23, which play a role in inflammatory processes. Ustekinumab is classified as a monoclonal antibody.

  • Guselkumab

    Guselkumab is also administered via subcutaneous injection and is under investigation in clinical trials for its potential benefits in treating juvenile psoriatic arthritis. It is recognized in medical literature for its use in managing plaque psoriasis. The primary therapeutic indication for guselkumab is to decrease inflammation and improve symptoms in autoimmune diseases. Its mechanism of action involves blocking the protein interleukin-23, which is involved in the inflammatory response. Guselkumab is categorized as a monoclonal antibody.

Investigated diseases

Juvenile Psoriatic Arthritis – Juvenile psoriatic arthritis is a type of inflammatory arthritis that affects children and is associated with the skin condition psoriasis. It typically causes joint pain, swelling, and stiffness, often in the fingers and toes, and may also lead to changes in the nails. The disease can progress with periods of increased symptoms, known as flares, and periods of remission where symptoms improve. Over time, it can lead to joint damage if not managed properly. The condition may also involve other symptoms such as fatigue and eye inflammation. It is considered a rare disease in the pediatric population.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-507144-36-00Protocol codeCNTO1275JPA3001Estimated enrolment56 patientsSponsorJanssen - Cilag International

sourced from the EU Clinical Trials Register and site verification

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