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Study on the Effects of JNJ-81241459 for Patients with Moderate to Severe Psoriasis

Fast replyInvestigational

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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 effects of a potential new medicine called JNJ-81241459 for treating individuals with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches to appear on the skin. The study aims to evaluate how effective and safe this new medicine is compared to an inactive medicine, also known as a placebo.

Participants in the study will receive either the new medicine JNJ-81241459 or a placebo in the form of tablets. The study will compare different doses of the new medicine to see which is most effective. The treatment period will last for up to 12 weeks, during which participants will take the tablets orally, meaning by mouth. The goal is to determine if the new medicine can significantly improve the symptoms of plaque psoriasis compared to the placebo.

The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the new medicine or the placebo. This helps ensure that the results are unbiased. The main objective is to see if participants achieve a significant reduction in their psoriasis symptoms by the end of the study period. This trial is an important step in potentially providing a new treatment option for those affected by moderate to severe plaque psoriasis.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of plaque psoriasis, and specific health criteria such as body surface area (BSA) and psoriasis area and severity index (PASI) scores.
Step 2
Randomization
Participants are randomly assigned to receive either the study medication JNJ-81241459 or a placebo. This process ensures that the study results are unbiased.
Step 3
Medication administration
Participants take the assigned medication orally in the form of a tablet. The study involves different doses of JNJ-81241459, including 200mg and 50mg, or a placebo tablet. The specific dosage and frequency are determined by the study protocol.
Step 4
Treatment period
The treatment period lasts for a specified duration, during which participants continue to take the medication as directed. Regular monitoring and assessments are conducted to evaluate the medication's effects.
Step 5
Evaluation of efficacy
The primary goal is to assess the efficacy of JNJ-81241459 compared to the placebo. This is measured by the percentage of participants achieving a 75% improvement in PASI score by week 12.
Step 6
Safety monitoring
Throughout the study, participants are monitored for any side effects or adverse reactions to ensure safety. Regular check-ups and tests are part of this process.
Step 7
Study completion
Upon completion of the study, participants undergo a final assessment to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

5 criteria

Must be at least 18 years old, or older if the legal age of consent is higher where the study is taking place.
Must have a diagnosis of plaque psoriasis, which is a skin condition that causes red, scaly patches.
Must have a Total BSA (Body Surface Area) of at least 10% at the start and during the study. This means that at least 10% of the skin is affected by psoriasis.
Must have a Total PASI (Psoriasis Area and Severity Index) score of at least 12 at the start and during the study. This is a measure used to assess the severity and extent of psoriasis.
Must have a Total IGA (Investigator's Global Assessment) score of at least 3 at the start and during the study. This is a scale used by doctors to rate the severity of psoriasis.

Who cannot join the trial?

7 criteria

Participants with any other skin conditions that might interfere with the study results.
Individuals who have used certain medications for psoriasis recently, as these could affect the study outcomes.
People with a history of allergic reactions to similar treatments.
Participants with serious health issues that could make it unsafe for them to take part in the study.
Women who are pregnant or breastfeeding, as the effects on the baby are unknown.
Individuals who have participated in another clinical trial recently, as this could interfere with the results.
People who are unable to follow the study procedures or attend the required visits.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Clinicmed Daniluk Nowak Sp. k.
Verified
Bialystok, Poland
EMC Instytut Medyczny S.A.
Verified
Poznan, Poland
Studienzentrum Dr. Beate Schwarz
Responsive
Langenau, Germany

Trial locations

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Investigated drugs

JNJ-81241459 is an investigational medication being studied for its potential to treat moderate to severe plaque psoriasis. This medication is being tested to see how well it can reduce the symptoms of psoriasis, which is a skin condition that causes red, scaly patches. The study aims to determine the effectiveness and safety of JNJ-81241459 in improving the condition of the skin in participants with this type of psoriasis.

Jnj-81241459

What is already known about the treatment

JNJ-81241459 – 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 in the investigational stage, meaning it is not yet approved for general medical use, but it is being evaluated for its potential benefits and safety. The main therapeutic indication for JNJ-81241459 is plaque psoriasis, a condition characterized by red, scaly skin patches. At the molecular level, it works by targeting specific pathways in the immune system that contribute to inflammation and skin cell overproduction. It is classified pharmacologically as an immunomodulatory agent, which means it helps regulate the immune system's activity.

Investigated diseases

Plaque Psoriasis – Plaque psoriasis is a chronic skin condition characterized by the development of thick, red patches covered with silvery-white scales. These patches, known as plaques, often appear on the elbows, knees, scalp, and lower back, but they can occur anywhere on the body. The condition results from an overactive immune system that speeds up the growth cycle of skin cells. As new skin cells form too quickly, they accumulate on the surface, leading to the formation of plaques. The affected areas can be itchy, painful, and may crack or bleed. The severity of plaque psoriasis can vary, with some individuals experiencing only minor patches and others having widespread, severe symptoms.