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Study on the Effectiveness and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab for Patients 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 effectiveness and safety of a new treatment for moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. The study will compare a new medication, known by its code name JNJ-77242113, with a commonly used treatment called Ustekinumab and a placebo. The purpose of the study is to evaluate how well JNJ-77242113 works in treating this condition.

Participants in the study will receive either the new medication, Ustekinumab, or a placebo. The new medication, JNJ-77242113, is taken as a film-coated tablet, while Ustekinumab is given as an injection. The study will last for several weeks, during which participants will be monitored to see how their psoriasis responds to the treatment. The goal is to see if the new medication can improve the symptoms of psoriasis, such as reducing the size and severity of the skin patches.

The study will involve regular check-ups to assess the condition of the skin and overall health. Participants will be randomly assigned to one of the treatment groups, and neither the participants nor the researchers will know which treatment is being given to ensure unbiased results. The study aims to provide valuable information on whether JNJ-77242113 is a safe and effective option for treating moderate to severe plaque psoriasis.

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

    Joining the study

    Upon joining the study, participants will be informed about the trial's purpose, which is to evaluate the effectiveness of a new medication called JNJ-77242113 for treating moderate to severe plaque psoriasis.

    Participants will be randomly assigned to receive either the new medication, a placebo (a substance with no active medication), or an existing treatment called ustekinumab.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to confirm eligibility, which includes being at least 12 years old and having a diagnosis of moderate to severe plaque psoriasis for at least 26 weeks.

    The assessment will also check the extent of the skin condition, ensuring a body surface area (BSA) of at least 10% and a psoriasis area and severity index (PASI) score of at least 12.

  3. Step 3

    Treatment phase

    Participants will begin the treatment phase, which involves taking the assigned medication.

    Those receiving JNJ-77242113 will take it orally in the form of a film-coated tablet. The specific dosage and frequency will be provided by the study team.

    Participants assigned to ustekinumab will receive it as a subcutaneous injection, which means it is injected under the skin. The dosage will be either 45 mg or 90 mg, depending on the participant's group.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, participants will have regular follow-up visits to monitor their health and the effectiveness of the treatment.

    These visits will include assessments of the skin condition and any side effects experienced. The goal is to achieve an improvement in the skin condition, measured by a reduction in the PASI score and an improvement in the investigator's global assessment (IGA) score.

  5. Step 5

    End of study evaluation

    At the end of the study, participants will undergo a final evaluation to assess the overall effectiveness and safety of the treatment.

    The study aims to achieve significant improvement in the skin condition by week 16, as measured by specific clinical endpoints.

Who can join the trial?

5 criteria

  • Must be at least 12 years old at the time of the screening visit.
  • Must have a diagnosis of moderate to severe plaque psoriasis for at least 26 weeks before the first study treatment. Psoriasis is a skin condition that causes red, scaly patches.
  • Must have a Body Surface Area (BSA) affected by psoriasis of at least 10% at screening and baseline. BSA is a way to measure the total area of the body affected by psoriasis.
  • Must have a PASI score of at least 12 at screening and baseline. PASI stands for Psoriasis Area and Severity Index, which measures the severity of psoriasis.
  • Must have an IGA score of at least 3 at screening and baseline. IGA stands for Investigator's Global Assessment, which is a scale used to assess the overall severity of psoriasis.

Who cannot join the trial?

9 criteria

  • Patients with any other skin conditions that might interfere with the study results cannot participate.
  • Patients who have had a recent infection or are currently experiencing an infection are not eligible.
  • Patients who have received certain treatments for psoriasis recently, such as biologics or systemic therapies, are excluded.
  • Patients with a history of certain serious diseases, like cancer or heart disease, cannot take part.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients who have participated in another clinical trial recently are not eligible.
  • Patients with a known allergy to any of the study medications or similar drugs cannot join the study.
  • Patients with a history of drug or alcohol abuse may be excluded.
  • Patients who are unable to comply with the study procedures or follow-up visits are not eligible.
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Investigated drugs

  • JNJ-77242113

    is an experimental medication being tested to see how well it works for people with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin. This medication is being studied to understand if it can help reduce these symptoms and improve the skin's appearance.

  • Ustekinumab

    is a medication already used to treat moderate to severe plaque psoriasis. It works by targeting specific proteins in the immune system that are involved in causing the skin symptoms. In this study, Ustekinumab is used as a comparison to see how well the new medication, JNJ-77242113, performs against a known treatment.

What is already known about the treatment

JNJ-77242113 – This medication is administered to patients in a clinical trial setting, primarily through injection. It is currently being studied for its effectiveness in treating moderate to severe plaque psoriasis, a skin condition characterized by red, scaly patches. The medication works by targeting specific molecules in the immune system that contribute to inflammation and the rapid growth of skin cells. JNJ-77242113 is classified as an immunomodulatory agent, which means it helps regulate the immune system to reduce symptoms of psoriasis.

Investigated diseases

Moderate to Severe Plaque Psoriasis – Plaque psoriasis is a chronic autoimmune condition characterized by the rapid growth of skin cells, leading to the formation of thick, red, scaly patches on the skin. These patches, or plaques, are often itchy and can appear anywhere on the body, but are most commonly found on the elbows, knees, scalp, and lower back. The disease progresses through cycles, with periods of increased activity (flare-ups) followed by times of remission. During flare-ups, the plaques can become more inflamed and widespread. The severity of the condition can vary, with moderate to severe cases involving more extensive skin coverage and more significant impact on quality of life. The exact cause of plaque psoriasis is not fully understood, but it involves a combination of genetic and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515706-77-00Protocol code77242113PSO3006Estimated enrolment772 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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