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Study on Bimekizumab and Ustekinumab for Children and Teens with Moderate to Severe Plaque Psoriasis

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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 treatments for moderate to severe plaque psoriasis in children and teenagers aged 6 to less than 18 years. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin. The study will compare the effectiveness and safety of two medications: bimekizumab and ustekinumab. Bimekizumab, also known by its code name UCB4940, and ustekinumab are both given as a solution for injection under the skin.

The purpose of the study is to evaluate how well bimekizumab works compared to ustekinumab in treating children and adolescents with this condition. Participants will receive either bimekizumab, ustekinumab, or a placebo, which is a substance with no active medication. The study will last for a period of time, during which participants will receive regular injections and attend follow-up visits to monitor their progress and any side effects.

Throughout the study, doctors will assess the improvement in the skin condition using specific measures, such as the Psoriasis Area and Severity Index (PASI) and the Investigator's Global Assessment (IGA). These assessments will help determine the effectiveness of the treatments. The study will also monitor any changes in the participants' overall health, including growth and quality of life, to ensure the safety of the treatments being tested.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period

    During this period, the participant will receive either bimekizumab or ustekinumab through subcutaneous injections. The specific dosage and frequency will be determined by the study protocol.

    The primary goal is to assess the effectiveness of the treatment by measuring the improvement in skin condition using the Psoriasis Area Severity Index (PASI) and the Investigator's Global Assessment (IGA) at Week 16.

  2. Step 2

    Maintenance period

    Following the initial treatment period, the participant will continue to receive the assigned treatment to maintain the improvements achieved.

    The participant's response will be monitored at various intervals, including Week 48, to evaluate long-term effectiveness and safety.

  3. Step 3

    Safety and efficacy assessments

    Throughout the trial, regular assessments will be conducted to monitor the participant's health and the treatment's impact. This includes checking for any adverse effects and changes in vital signs, physical examination findings, and laboratory results.

    The participant's quality of life and any changes in symptoms will also be evaluated using specific questionnaires and scales.

  4. Step 4

    End of study evaluations

    At the conclusion of the study, final assessments will be performed to determine the overall effectiveness and safety of the treatment.

    The participant's progress and any long-term effects of the treatment will be documented and analyzed.

Who can join the trial?

9 criteria

  • The participant must be between 6 and less than 18 years old at the time of signing the consent form.
  • The participant must have been diagnosed with moderate to severe plaque psoriasis for at least 3 months before the screening visit. Plaque psoriasis is a skin condition that causes red, scaly patches.
  • At both the screening and baseline visits, the participant must have:
    • Body surface area (BSA) affected by psoriasis of 10% or more. This means that at least 10% of the skin is affected by psoriasis.
    • An Investigator's Global Assessment (IGA) score of 3 or more on a scale from 0 to 4. This score helps to measure the severity of psoriasis.
    • A Psoriasis Area and Severity Index (PASI) score of 12 or more, or a PASI score of 10 or more with at least one of the following:
      • Significant involvement of the face.
      • Significant involvement of the genital area.
      • Significant involvement of the hands and feet.
      • The participant must be eligible for systemic psoriasis therapy, which involves medication that affects the whole body, and/or phototherapy or chemotherapy, as well as treatment with ustekinumab, according to its guidelines.
      • The participant must weigh at least 15 kg and have a body mass index (BMI) for their age in the 5th percentile or higher at the screening. BMI is a measure that uses height and weight to estimate body fat.

Who cannot join the trial?

15 criteria

  • Patients who have any other serious health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have received certain vaccines recently.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have certain blood disorders.
  • Patients who have a weakened immune system.
  • Patients who have had a recent surgery.
  • Patients who have certain skin conditions other than psoriasis.
  • Patients who have a history of cancer.
  • Patients who have liver or kidney problems.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have heart problems.
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Investigated drugs

  • Bimekizumab

    is a medication being studied for its effectiveness in treating moderate to severe plaque psoriasis in children and adolescents. It is given as an injection under the skin. The goal is to see how well it works in reducing the symptoms of psoriasis, which is a skin condition that causes red, scaly patches.

  • Ustekinumab

    is another medication used in this study as a comparison to bimekizumab. It is also used to treat moderate to severe plaque psoriasis and is administered through an injection. The study aims to compare the effectiveness and safety of ustekinumab with bimekizumab in managing psoriasis symptoms in young patients.

What is already known about the treatment

  • Bimekizumab

    Bimekizumab is administered through subcutaneous injection and is currently being studied for its effectiveness in treating moderate to severe plaque psoriasis in children and adolescents. It is in the clinical trial phase, comparing its efficacy and safety to another medication, ustekinumab. Bimekizumab works by inhibiting specific proteins in the immune system that contribute to inflammation, helping to reduce the symptoms of psoriasis. It is classified as a monoclonal antibody, targeting interleukin-17A and interleukin-17F to decrease inflammation and plaque formation on the skin.

  • Ustekinumab

    Ustekinumab is also administered via subcutaneous injection and is an established treatment for moderate to severe plaque psoriasis. It is being used as a control in clinical trials to compare its effectiveness against bimekizumab in younger patients. Ustekinumab functions by targeting interleukin-12 and interleukin-23, proteins involved in inflammatory processes, thereby reducing the immune response that leads to psoriasis symptoms. It is classified as a monoclonal antibody and is widely recognized in medical literature for its role in managing psoriasis.

Investigated diseases

Moderate to Severe Plaque Psoriasis – This is a chronic skin condition characterized by red, scaly patches that can appear anywhere on the body. The patches, known as plaques, are often itchy and can be painful. The disease occurs when skin cells multiply faster than normal, leading to a buildup of cells on the skin's surface. It typically progresses with periods of flare-ups and remission. The severity can vary, with moderate to severe cases covering larger areas of the body and causing more significant discomfort. Environmental factors, stress, and certain medications can trigger or worsen the symptoms.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-503859-10-00Protocol codePS0021Estimated enrolment168 patientsSponsorUCB Biopharma

sourced from the EU Clinical Trials Register and site verification

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