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Study on Guselkumab and Etanercept for Treating Chronic Plaque Psoriasis in Children Aged 6 to 17 Years

Fast replyRegistered 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 treatment of Chronic Plaque Psoriasis in children and teenagers aged 6 to 18 years. The study will evaluate the effectiveness and safety of a medication called Guselkumab, which is a type of protein known as a monoclonal antibody. This medication is given as an injection under the skin using a pre-filled syringe. The trial will also compare Guselkumab with another medication called Etanercept, which is also used to treat psoriasis, and with a placebo.

The purpose of the study is to assess how well Guselkumab works in reducing the symptoms of Chronic Plaque Psoriasis in young patients. Participants in the study will receive either Guselkumab, Etanercept, or a placebo. The study will last for a period of up to 52 weeks, during which participants will receive regular injections and attend follow-up visits to monitor their progress and any side effects. The study aims to determine if Guselkumab can help improve the condition of the skin and overall health of the participants.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and well-being. The trial will provide valuable information on the use of Guselkumab in treating Chronic Plaque Psoriasis in a younger population, potentially offering a new treatment option for those affected by this condition.

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 visit

    Upon joining the study, you will attend an initial visit. During this visit, a healthcare professional will review your medical history and conduct a physical examination to ensure you meet the study criteria.

    You will be asked to provide evidence of immunity to certain diseases, such as varicella and measles, mumps, and rubella (MMR). This can be through vaccination records or a blood test showing protective antibodies.

  2. Step 2

    Baseline assessment

    A baseline assessment will be conducted to evaluate the severity of your chronic plaque psoriasis. This includes measuring the Psoriasis Area and Severity Index (PASI) and the Investigator Global Assessment (IGA).

    The assessment will help determine the extent of your skin condition and ensure it meets the study's requirements.

  3. Step 3

    Treatment phase

    You will be randomly assigned to receive either guselkumab or etanercept, or a placebo. The medication will be administered through a subcutaneous injection, which means it is injected under the skin.

    If you receive guselkumab, it will be provided as a 100 mg/mL solution in a pre-filled syringe. If you receive etanercept, it will be provided as a 25 mg or 50 mg solution for injection.

    The frequency and duration of the medication administration will be explained to you by the healthcare team.

  4. Step 4

    Follow-up visits

    You will have regular follow-up visits to monitor your response to the treatment and any side effects. These visits will include physical examinations and assessments of your psoriasis.

    The primary goal is to evaluate the proportion of participants achieving a PASI 75 response at week 16, which means a 75% improvement in the severity and extent of psoriasis.

  5. Step 5

    End of study

    At the end of the study, a final assessment will be conducted to evaluate the overall effectiveness and safety of the treatment.

    You will be informed about the results of your participation and any further steps if necessary.

Who can join the trial?

12 criteria

  • Must have a diagnosis of chronic plaque psoriasis for at least 6 months. This means having a skin condition with red, scaly patches for a long time.
  • Must have a certain level of psoriasis severity, which includes:
    • Investigator Global Assessment (IGA) score of 3 or higher. This is a way doctors rate the severity of psoriasis.
    • Psoriasis Area and Severity Index (PASI) score of 12 or higher. This is another way to measure how severe the psoriasis is.
    • Psoriasis covering 10% or more of the body.
    • At least one of the following: very thick skin patches, psoriasis on the face, genitals, hands, or feet, PASI score of 20 or higher, psoriasis covering more than 20% of the body, or IGA score of 4.
    • Must be a candidate for phototherapy or systemic treatment for psoriasis. Phototherapy is a treatment using light, and systemic treatment involves medication that affects the whole body.
    • Psoriasis must not be well controlled with phototherapy or creams/ointments after trying them for a sufficient time.
    • Must be considered suitable for etanercept therapy by the doctor. Etanercept is a medication used to treat psoriasis.
    • Must be otherwise healthy based on a physical exam, medical history, and vital signs. Any health issues should be related to psoriasis and noted by the doctor.
    • Must have proof of immunity to varicella (chickenpox) and measles, mumps, and rubella (MMR)
    • Having received the full set of vaccines for these diseases.
    • Having had these diseases in the past, confirmed by a doctor.
    • Having positive antibody tests showing protection against these diseases.

Who cannot join the trial?

10 criteria

  • Patients who have any other skin conditions that might interfere with the study results.
  • Patients who have had any recent infections that required treatment with antibiotics or other medications.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have received any other treatment for psoriasis within a certain period before the study starts.
  • Patients who have any significant medical conditions that could affect their participation in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have been vaccinated with a live vaccine within a certain period before the study.
  • Patients who have any known immune system disorders.
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Investigated drugs

Guselkumab is a medication used in this clinical trial to treat chronic plaque psoriasis in children and teenagers. It is given as an injection under the skin. Guselkumab works by targeting a specific protein in the body that causes inflammation and skin symptoms in psoriasis. By blocking this protein, the medication helps reduce the redness, thickness, and scaling of the skin patches associated with psoriasis. This trial aims to see how well guselkumab works and how safe it is for young patients with this skin condition.

What is already known about the treatment

Guselkumab – Guselkumab is administered through an injection under the skin, a method known as subcutaneous administration. It is currently being studied in clinical trials for its effectiveness and safety in treating chronic plaque psoriasis, particularly in children aged 6 to 18 years. This medication is primarily used to help manage chronic plaque psoriasis, a skin condition that causes red, scaly patches. At the molecular level, guselkumab works by targeting a specific protein in the immune system called interleukin-23 (IL-23), which plays a role in inflammation and the overproduction of skin cells. It is classified as a biologic medication, which means it is made from living organisms or their cells.

Investigated diseases

Chronic Plaque Psoriasis – Chronic Plaque Psoriasis is a long-lasting autoimmune skin condition characterized by the rapid growth of skin cells, leading to thick, red, scaly patches on the skin. These patches, known as plaques, often appear on the elbows, knees, scalp, and lower back, but can occur anywhere on the body. The condition is caused by an overactive immune system that mistakenly attacks healthy skin cells, causing inflammation and accelerated skin cell production. The plaques can be itchy, painful, and may crack and bleed. The severity of the disease can vary, with some individuals experiencing only minor irritation, while others may have widespread, severe plaques. The condition tends to go through cycles, with periods of flare-ups followed by times of remission.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-503378-19-00Estimated enrolment117 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).