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Study on the Effectiveness and Safety of JNJ-77242113 for Treating Plaque Psoriasis in Special Areas for Patients with Moderate to Severe Symptoms

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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 plaque psoriasis, a skin condition that causes red, scaly patches. The treatment being tested is a medication known as JNJ-77242113, which is taken as a film-coated tablet. The study will compare the effects of this medication to a placebo, which looks like the real medication but does not contain the active ingredient.

The purpose of the study is to evaluate how well JNJ-77242113 works in people with moderate to severe plaque psoriasis, especially in areas that are difficult to treat. Participants will be randomly assigned to receive either the medication or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. The study will last for several months, during which participants will take the medication or placebo and attend regular check-ups to monitor their progress and any side effects.

Throughout the study, the main goal is to see if the medication can improve the condition of the skin by reducing the severity of the psoriasis patches. Participants will be assessed at various points to determine if there is a noticeable improvement in their skin condition. This trial aims to provide valuable information about the potential benefits of JNJ-77242113 for individuals living with 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.

Step 1
Joining the study
Upon joining the study, the participant is required to meet specific criteria, including being at least 12 years old and having a diagnosis of plaque psoriasis for at least 26 weeks. The participant must be a candidate for phototherapy or systemic treatment and have failed to respond to at least one topical therapy.
Step 2
Randomization and treatment assignment
Participants are randomly assigned to receive either the active medication, JNJ-77242113, or a placebo. The study is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
Step 3
Medication administration
The medication, JNJ-77242113, is provided in the form of a film-coated tablet for oral use. The dosage and frequency of administration are determined by the study protocol and are followed throughout the trial.
Step 4
Monitoring and assessments
Participants undergo regular monitoring and assessments to evaluate the efficacy and safety of the treatment. This includes measuring the improvement in the overall condition of plaque psoriasis, with a focus on achieving an IGA (Investigator's Global Assessment) score of 0 or 1 and a 2-grade improvement from baseline by Week 16.
Step 5
Completion of the study
The study is estimated to conclude by March 31, 2027. Participants will continue to be monitored until the end of the study to ensure comprehensive data collection and analysis.

Who can join the trial?

9 criteria

Must be at least 12 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.
Should be a candidate for phototherapy or systemic treatment for plaque psoriasis. Phototherapy is a treatment using light, and systemic treatment involves medication that works throughout the body.
Must meet certain criteria related to the severity and extent of psoriasis:
- Total BSA (Body Surface Area) affected by psoriasis should be at least 1% at screening and baseline.
- IGA (Investigator's Global Assessment) score should be at least 2 at screening and baseline. This is a measure of the overall severity of psoriasis.
- At least one of the following scores should be 3 or higher at screening and baseline:
  - ss-IGA (site-specific Investigator's Global Assessment) score
  - sPGA-G (static Physician's Global Assessment of Genitalia) score
  - hf-PGA (head, face, and neck Physician's Global Assessment) score
  - Must have tried at least one topical therapy for psoriasis that did not work. Topical therapy is a treatment applied directly to the skin.

Who cannot join the trial?

10 criteria

Individuals with any other skin conditions that might interfere with the study results.
People who have had a recent infection or are currently experiencing an infection.
Participants who have used certain medications that could affect the study outcomes.
Individuals with a history of certain medical conditions that could pose a risk during the study.
Pregnant or breastfeeding women.
Participants who have been part of another clinical trial recently.
Individuals with a known allergy to any of the study medications.
People who have had a recent vaccination.
Participants with a history of drug or alcohol abuse.
Individuals who are unable to comply with the study procedures.

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Verified sites

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CRS Clinical Research Services Management GmbH
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Berlin, Germany
Goethe University Frankfurt
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Frankfurt, Germany
Hospital Del Mar
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Barcelona, Spain

Trial locations

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Investigated drugs

JNJ-77242113 is a medication being studied for its effectiveness and safety in treating plaque psoriasis, particularly in areas that are more challenging to manage. Plaque psoriasis is a skin condition that causes red, scaly patches, and this medication aims to help reduce the severity of these symptoms. The trial focuses on participants who have moderate to severe plaque psoriasis affecting specific areas of the body.

Jnj-77242113

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 plaque psoriasis, particularly in areas that are difficult to manage. It is in the experimental phase and not yet widely available in medical practice. The main therapeutic indication is for moderate to severe plaque psoriasis, especially in special areas of the body. JNJ-77242113 works by targeting specific pathways in the immune system to reduce inflammation and slow down the overproduction of skin cells. It is classified as an immunomodulatory agent.

Investigated diseases

Plaque Psoriasis – Plaque psoriasis is a chronic autoimmune condition that causes the rapid growth of skin cells, leading to the formation of thick, red, scaly patches on the skin. These patches, known as plaques, are often itchy and can be painful. The condition commonly affects areas such as the elbows, knees, scalp, and lower back, but it can appear anywhere on the body. The severity of plaque psoriasis can vary, with some individuals experiencing only minor patches, while others may have widespread areas of thickened skin. The disease tends to go through cycles, with periods of flare-ups followed by times of remission. Environmental factors, stress, and certain medications can trigger or worsen the symptoms.