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Study on the Effectiveness and Safety of JNJ-77242113 and Deucravacitinib for Adults 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 treatment of moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches on the skin. The study will evaluate a new medication called JNJ-77242113, which is taken as a film-coated tablet. The purpose of the study is to assess how effective and safe this medication is compared to a placebo and another medication called Deucravacitinib, which is already used to treat psoriasis.

Participants in the study will be randomly assigned to receive either the new medication, the placebo, or Deucravacitinib. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps ensure that the results are unbiased. The study will take place over several weeks, during which participants will take the medication orally and attend regular check-ups to monitor their progress and any side effects.

The goal is to determine if JNJ-77242113 can improve the symptoms of plaque psoriasis more effectively than the placebo or Deucravacitinib. Participants will be monitored for changes in their skin condition and overall health. The study aims to provide valuable information that could lead to new treatment options for people living with moderate to severe plaque psoriasis.

The research process

The trial runs in 6 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, the participant is confirmed to meet the inclusion criteria, which include being 18 years or older, having a diagnosis of plaque psoriasis for at least 26 weeks, and meeting specific severity criteria for the condition.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of the study groups. This process is double-blind, meaning neither the participants nor the researchers know which treatment the participant is receiving.

  3. Step 3

    Treatment phase

    Participants receive either the investigational drug JNJ-77242113, a placebo, or the active comparator Deucravacitinib. Both medications are administered as film-coated tablets taken orally.

    The dosage and frequency of administration are determined by the study protocol, which is not specified in the provided data.

  4. Step 4

    Monitoring and assessments

    Throughout the study, participants undergo regular assessments to monitor the efficacy and safety of the treatment. This includes evaluating the severity of psoriasis using standardized scoring systems.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment period, participants are evaluated to determine the primary outcomes, which include achieving a specific improvement in psoriasis severity scores by Week 16.

  6. Step 6

    Follow-up

    Participants may be required to attend follow-up visits to monitor any long-term effects of the treatment.

Who can join the trial?

5 criteria

  • Must be at least 18 years old at the time of the screening visit.
  • Must have been diagnosed with plaque psoriasis for at least 26 weeks before the first study treatment. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin.
  • 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 the body is affected by psoriasis.
  • 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 is a tool used to measure 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

  • Having any other skin conditions that might interfere with the study results.
  • Having a history of allergic reactions to similar medications.
  • Currently participating in another clinical trial.
  • Having a serious infection or illness that requires treatment.
  • Being pregnant or planning to become pregnant during the study.
  • Having a history of certain heart conditions.
  • Using certain medications that might interfere with the study.
  • Having a history of drug or alcohol abuse.
  • Having a weakened immune system, which means the body's defense against infections is not strong.
  • Having received certain vaccines recently.
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Investigated drugs

  • JNJ-77242113

    is an investigational medication being studied for its effectiveness in treating moderate to severe plaque psoriasis. This medication is being compared to a placebo to determine how well it works in reducing the symptoms of psoriasis, which is a skin condition that causes red, scaly patches.

  • Deucravacitinib

    is an active comparator in this study. It is a medication that is already used to treat moderate to severe plaque psoriasis. The study aims to compare the effectiveness and safety of JNJ-77242113 against Deucravacitinib to see if the new medication offers any advantages.

What is already known about the treatment

JNJ-77242113 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating moderate to severe plaque psoriasis. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for JNJ-77242113 is to alleviate symptoms associated with plaque psoriasis, a chronic skin condition. At the molecular level, it works by targeting specific pathways in the immune system to reduce inflammation and slow down the overproduction of skin cells. It is classified pharmacologically as an immunomodulator.

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. These plaques can vary in size and may join together to form larger areas. The condition can fluctuate, with periods of improvement and worsening. It is not contagious and can affect individuals differently, with some experiencing more severe symptoms than others.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507039-39-00Protocol code77242113PSO3004Estimated enrolment698 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).