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Study on the Effectiveness of JNJ-77242113 and Deucravacitinib for Treating Moderate to Severe Plaque Psoriasis in Adults

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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 moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches on the skin. The study will evaluate the effectiveness and safety of a new medication called JNJ-77242113, which is taken as a film-coated tablet. Another medication, Deucravacitinib, will also be used as a comparison to see how well JNJ-77242113 works. Some participants will receive a placebo, which looks like the real medication but does not contain any active ingredients.

The purpose of the study is to determine how effective JNJ-77242113 is in treating moderate to severe plaque psoriasis compared to a placebo. Participants in the study will be randomly assigned to receive either JNJ-77242113, Deucravacitinib, or a placebo. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps ensure that the results are not biased. The study will last for several months, with regular check-ups to monitor the participants' health and the effects of the treatment.

Throughout the study, participants will take the medication orally, which means they will swallow the tablets. The study aims to provide valuable information about the potential benefits and safety of JNJ-77242113 for people with moderate to severe plaque psoriasis. By comparing it to both a placebo and Deucravacitinib, researchers hope to better understand how well JNJ-77242113 works in improving the symptoms of this skin 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

    Joining the study

    Upon joining the study, you will be randomly assigned to one of the treatment groups. This means you will either receive the new medication JNJ-77242113, a placebo, or the active comparator deucravacitinib. The assignment is random to ensure fairness and accuracy in the study results.

  2. Step 2

    Medication administration

    If you are assigned to the JNJ-77242113 group, you will take the medication orally in the form of a film-coated tablet. The exact dosage and frequency will be provided by the study team.

    If you are in the deucravacitinib group, you will also take the medication orally as a film-coated tablet. The study team will inform you of the specific dosage and frequency.

    If you are in the placebo group, you will take a tablet that looks like the medication but does not contain the active substance. This is to help compare the effects of the actual medication.

  3. Step 3

    Regular check-ups

    Throughout the study, you will have regular check-ups to monitor your health and the effects of the medication. These check-ups are important to ensure your safety and to gather data on the medication's effectiveness.

  4. Step 4

    Evaluation of results

    At week 16, your condition will be evaluated to see if there has been an improvement. The primary goal is to achieve an IGA score of 0 or 1, which indicates clear or almost clear skin, and a significant improvement from the start of the study.

    Another important measure is the PASI 90, which means a 90% improvement in your psoriasis condition compared to the beginning of the study.

  5. Step 5

    Completion of the study

    Once the study period is over, you will have a final evaluation. This will help determine the overall effectiveness and safety of the medication you received.

Who can join the trial?

5 criteria

  • Must be at least 18 years old at the time of the screening visit.
  • Must have a diagnosis of plaque psoriasis for at least 26 weeks before the first study treatment. Plaque 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 at the start of the study. BSA is a way to measure how much of your body is affected.
  • Must have a PASI score of at least 12 at screening and at the start of the study. 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 at the start of the study. IGA stands for Investigator's Global Assessment, which is a scale used to assess the overall severity of psoriasis.

Who cannot join the trial?

10 criteria

  • Patients with any other skin conditions that might interfere with the study results.
  • Patients who have had recent major surgery or are planning to have surgery during the study period.
  • Patients who have received any other investigational drug within the last 30 days.
  • Patients with a history of severe allergic reactions to any medication.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of drug or alcohol abuse within the past year.
  • Patients with any serious medical conditions that are not well controlled.
  • Patients who have been diagnosed with any type of cancer in the past 5 years, except for certain skin cancers.
  • Patients who have received certain treatments for psoriasis within a specific time frame before the study.
  • Patients with active infections or a history of recurrent infections.
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Investigated drugs

  • JNJ-77242113

    is a new medication being tested to see if it can help 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 reduce the symptoms and improve the skin condition of those affected by this disease.

  • Deucravacitinib

    is another medication used in this study as a comparison to the new medication, JNJ-77242113. It is already known to help treat plaque psoriasis by targeting specific pathways in the body that contribute to the inflammation and skin symptoms. By comparing it with the new medication, researchers aim to see how effective the new treatment is in comparison to an existing option.

What is already known about the treatment

JNJ-77242113 – This medication is administered orally in the form of a tablet. It is currently being studied in clinical trials for its effectiveness in treating moderate to severe plaque psoriasis, a skin condition characterized by red, scaly patches. The main therapeutic indication for JNJ-77242113 is to alleviate the symptoms of this condition. At the molecular level, it works by targeting specific pathways in the immune system that are involved in the inflammation and overproduction of skin cells. JNJ-77242113 is classified pharmacologically as a small molecule inhibitor, which means it interferes with certain proteins to reduce inflammation and slow down the rapid growth of skin cells.

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 known as plaques. These plaques often appear on the elbows, knees, scalp, and lower back, but they can occur anywhere on the body. The disease progresses through cycles, with periods of increased activity (flare-ups) followed by periods of remission. During flare-ups, the plaques can become itchy, painful, and may crack or bleed. 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, immune, and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505121-14-00Protocol code77242113PSO3002Estimated enrolment742 patientsSponsorJanssen Cilag International

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