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Study of apremilast compared to placebo in children aged 5-17 years with juvenile psoriatic arthritis

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What is this trial about?

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

This study focuses on Juvenile Psoriatic Arthritis, a condition that causes joint inflammation in children and is often accompanied by a skin condition called psoriasis. The research examines the effectiveness of a medication called Apremilast, which will be compared to placebo in children aged 5 to less than 18 years old. The purpose of this study is to determine if Apremilast can help treat the symptoms of Juvenile Psoriatic Arthritis in young patients.

During the study, participants will receive either Apremilast (known as AMG 407) or placebo in the form of tablets or oral solution. The medication or placebo will be taken by mouth. The treatment period will last for 52 weeks, with the main assessment of the medication's effectiveness occurring at week 16.

The study will monitor several aspects of the disease, including joint pain, inflammation, and overall disease activity. For participants who also have psoriasis affecting their skin, the improvement in skin symptoms will also be evaluated. The medication will be provided in different strengths, including 10 mg, 20 mg, and 30 mg tablets, as well as a liquid form containing 5 mg/mL.

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 phase - trial start

    You will be randomly assigned to receive either apremilast or a placebo (inactive tablet that looks the same as the medication).

    The medication will be provided in the form of film-coated tablets or oral solution, depending on your assigned group.

  2. Step 2

    Treatment period - first 16 weeks

    You will take either apremilast or placebo tablets by mouth daily.

    The tablets come in different strengths: 10 mg, 20 mg, and 30 mg. An oral solution of 5 mg/mL is also available.

    Your doctor will monitor your joint symptoms and overall health during this period.

    The main goal is to measure improvement in your joint condition after 16 weeks of treatment.

  3. Step 3

    Evaluation at week 16

    Your doctor will assess your response to treatment by checking:

    Changes in joint pain and swelling

    Your ability to perform daily activities

    If you have psoriasis patches covering 3% or more of your skin, these areas will also be evaluated

    Your overall disease activity will be measured using specific assessment tools

  4. Step 4

    Extended treatment period

    The study continues beyond the initial 16-week period

    You will continue receiving the assigned treatment while being monitored for safety and effectiveness

    Regular check-ups will track your progress and any changes in your condition

  5. Step 5

    Study completion

    The study is planned to continue until December 2028

    Your participation duration will be determined by your doctor based on your response to treatment and overall health

Who can join the trial?

10 criteria

  • Age between 5 and 17 years old at the time of study start
  • Must have a confirmed diagnosis of Juvenile Psoriatic Arthritis (JPsA) for at least 6 months, with either:
    • Both joint inflammation and skin psoriasis, or
    • Joint inflammation plus at least 2 of these conditions:
      • Dactylitis (finger or toe swelling)
      • Nail changes (pitting or separation from nail bed)
      • A parent, sibling, or child with psoriasis
      • Must have at least 3 active joints with inflammation
      • Must have tried at least one DMARD (Disease-Modifying Anti-Rheumatic Drug) for at least 2 months with:
        • Either inadequate response to the treatment, or
        • Unable to tolerate the medication
        • Both male and female patients can participate
        • Additional specific requirements as defined in the study protocol must be met

Who cannot join the trial?

15 criteria

  • Age below 5 years or 18 years and older
  • History of serious infections in the past 3 months
  • Active tuberculosis (a bacterial infection primarily affecting the lungs)
  • Current treatment with other medications for psoriatic arthritis
  • Pregnancy or breastfeeding
  • Serious heart conditions
  • Severe liver disease
  • Active or recent cancer
  • Uncontrolled high blood pressure
  • History of allergic reactions to similar medications
  • Participation in other clinical trials within the past 30 days
  • Major surgery planned during the study period
  • Active infections requiring treatment
  • Significant kidney problems
  • Mental health conditions that could interfere with study participation
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Investigated drugs

Apremilast is a medication used to treat psoriatic arthritis in children and teenagers. It works by reducing inflammation in the joints and skin by blocking certain substances in the body that cause inflammation. This medication helps manage the symptoms of juvenile psoriatic arthritis, including joint pain, swelling, and stiffness. It comes in a form that can be taken by children aged 5 to 17 years old.

What is already known about the treatment

Apremilast – An oral medication administered in tablet form that works as a phosphodiesterase-4 (PDE4) inhibitor, primarily used in the treatment of juvenile psoriatic arthritis in children aged 5 to 18 years. The medication functions by reducing inflammation at the cellular level by blocking the PDE4 enzyme, which leads to decreased production of pro-inflammatory mediators. This prescription medication belongs to the class of disease-modifying antirheumatic drugs (DMARDs) and has demonstrated effectiveness in managing symptoms of psoriatic arthritis in pediatric patients through controlled clinical trials.

Investigated diseases

Juvenile Psoriatic Arthritis - A chronic inflammatory condition that affects children and teenagers under 18 years of age, combining symptoms of arthritis and psoriasis. The condition causes joint pain, stiffness, and swelling, primarily affecting larger joints such as knees, ankles, and wrists. Children may also develop scaly, red patches on their skin characteristic of psoriasis. The condition tends to develop gradually, with symptoms varying in intensity over time. Some children may experience swelling in fingers or toes, giving them a sausage-like appearance, known as dactylitis. The disease can also cause nail changes, including pitting or separation from the nail bed.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-503435-17-00Protocol code20190529Estimated enrolment67 patientsSponsorAmgen Inc.

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