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

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What is this study about?

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.

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.

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
ICMR (International Center for Medical Research) Madrid Spain
Studienzentrum Dr. Beate Schwarz Langenau Germany
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Clinicmed Daniluk Nowak Sp. k. Bialystok Poland
Centrum Medyczne All-Med Badania Kliniczne Cracow Poland
Tagast 41 Nice France
ISA Interdisciplinary Study Association GmbH Berlin Germany
Hospital General Universitario De Alicante Alicante Spain
Klinische Forschung Osnabrueck Osnabrück Germany
Hospital Universitario Clínico San Cecilio Granada Spain
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Centre Hospitalier Le Mans Le Mans France
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Pratia S.A. Skorzewo Poland
HELIOS Kliniken Schwerin GmbH Schwerin Germany
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
Pkfsagjappv Eqobnyxsejwv Wroclaw Poland
Srmsxotpamwiki ad daj Hjjy Gub Bramsche Germany
Hvkypkif De Lx Sdhau Cdmz I Sibu Pql Barcelona Spain
Idksyfot dm Cufamkmluzvx Hwdyiqniafa Udotmlgstisuu dm Skwub Eengixf (avkvjdg Saint Priest En Jarez France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
29.05.2024
Germany Germany
Not recruiting
29.05.2024
Poland Poland
Not recruiting
29.05.2024
Spain Spain
Not recruiting
29.05.2024

Trial locations

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.

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.

Trial ID:
2023-508992-35-00
Trial Phase:
Therapeutic exploratory (Phase II)

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