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

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a new treatment for individuals with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches to appear on the skin. The treatment being tested is a medication known by its code name, JNJ-77242113, which is taken as a film-coated tablet. The study will compare this medication to a placebo to determine how well it works in improving the symptoms of plaque psoriasis.

The purpose of the study is to evaluate how effective JNJ-77242113 is in treating people with moderate to severe plaque psoriasis. Participants in the study will be randomly assigned to receive either the medication or a placebo. The study will involve a period where participants take the medication, followed by a withdrawal phase, and then a possible retreatment phase. This approach helps researchers understand the medication’s long-term effects and how it performs when treatment is paused and then restarted.

Throughout the study, participants will be monitored to assess the improvement in their psoriasis symptoms. The study aims to see if participants achieve a significant reduction in the severity of their skin condition by the end of the treatment period. The trial is designed to ensure that the medication is both effective and safe for those who take it. Participants will be closely observed by medical professionals to track any changes in their condition and to ensure their well-being during the study.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the study medication, JNJ-77242113, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.

The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are unbiased.

2 initial treatment phase

During the initial treatment phase, you will take the assigned tablet orally. The dosage and frequency will be provided by the study team.

This phase lasts for 16 weeks. The goal is to evaluate the effectiveness of the treatment in reducing the symptoms of moderate to severe plaque psoriasis.

3 evaluation at week 16

At the end of week 16, your condition will be evaluated. The primary goal is to see if there is a significant improvement in your skin condition.

The evaluation will include checking if your skin has cleared significantly or if there is a noticeable reduction in the severity of your psoriasis.

4 randomized withdrawal phase

If you respond well to the treatment, you may enter a randomized withdrawal phase. This means you might continue with the treatment or switch to a placebo without knowing.

This phase helps determine if the treatment’s effects are sustained over time without continuous medication.

5 retreatment phase

If your condition worsens during the withdrawal phase, you may be eligible for retreatment with JNJ-77242113.

The study team will guide you through this process and monitor your response to the retreatment.

6 end of study

At the end of the study, you will undergo a final evaluation to assess the overall effectiveness and safety of the treatment.

The study team will discuss the results with you and provide any necessary follow-up care or recommendations.

Who Can Join the Study?

  • Must be at least 12 years old at the time of the screening visit.
  • Must have a diagnosis of plaque psoriasis (a skin condition) for at least 26 weeks before the first study treatment. This can be with or without psoriatic arthritis (a type of arthritis that affects some people with psoriasis).
  • Must have 10% or more of their body surface area (BSA) affected by psoriasis at screening and at the start of the study. BSA is a way to measure how much of the body is affected.
  • Must have a PASI score of 12 or higher at screening and at the start of the study. PASI (Psoriasis Area and Severity Index) is a tool used to measure the severity and extent of psoriasis.
  • Must have an IGA score of 3 or higher at screening and at the start of the study. IGA (Investigator’s Global Assessment) is a scale used to assess the overall severity of psoriasis.

Who Cannot Join the Study?

  • Patients with any other skin conditions that might interfere with the study results.
  • Patients who have had a recent infection or are currently experiencing an infection.
  • Patients who have received any other treatment for psoriasis within a certain period before the study.
  • Patients with a history of certain serious diseases, such as cancer or heart disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients with a known allergy to any of the study medications.
  • Patients 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
IRCCS Humanitas Research Hospital Rozzano Italy
Specjalistyczny Gabinet Dermatologiczno- Kosmetyczny Cracow Poland
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik Bialystok Poland
Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy M. Brzewski, P. Brzewski S.C. Cracow Poland
Hospital Universitario De Salamanca Salamanca Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Dermed Centrum Medyczne Sp. z o.o. Lodz Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Lodz Poland
DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski s.c. Osielsko Poland
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy

Other Sites

Site Name City Country Status
Derma-B Kft. Debrecen Hungary
Hopital Prive D Antony Antony France
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
University Of Pecs Pecs Hungary
Klinikum Oldenburg AöR Oldenburg In Holstein Germany
Centre Hospitalier Victor Dupouy Argenteuil France
University Of Debrecen Debrecen Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Specderm Poznanska Sp. j. Bialystok Poland
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
ProDerma Duelmen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Universita’ Di Pisa Pisa Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Charite Research Organisation GmbH Berlin Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Servei De Salut De Les Illes Balears Palma Spain
Wromedica I Bielicka A Strzalkowska s.c. Wroclaw Poland
Promed P.Lach R.Glowacki Sp. j. Cracow Poland
Hospital Universitario Basurto Bilbao Spain
Centrum Medyczne Oporow Wroclaw Poland
ARNAS Civico Di Cristina Benfratelli Palermo Italy
Derma-Study-Center Friedrichshafen GmbH Friedrichshafen Germany
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR Blankenfelde-Mahlow Germany
Klinika Ambroziak Sp. z o.o. Warsaw Poland
Allergo-Derm Bakos Kft. Szolnok Hungary
University Of Szeged Szeged Hungary
Westfaelische Wilhelms Universitaet Muenster Munster Germany
Dorota Bystrzanowska High­ Med Przychodnia Specjalistyczna Warsaw Poland
Vital Medical Center Veszprem Hungary
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Elblag Poland
Dnbjmrivsk Svw z omvd Wroclaw Poland
Sksprjp Chrqnul Mykpjpps Sta z oouk Poznan Poland
Hbgkknhhnzdkkl Dz Mqj Mpslqbdg Hojtmnry Witten Germany
Mqdtnzdqy Dxhpnxbyarer Remscheid Germany
Gpegag Ubnyfhzcqs Fvlvtgunp Frankfurt Germany
Hsgfojnp Df Lu Sqlge Cwnd I Smcv Pux Barcelona Spain
Aweafhs Ogjzxutofcp Uqurodfetsrbc Pnqyh Parma Italy
Kcztyolqz Fkvwpszsw Dixelmj Gqmb Dresden Germany
Tbhhcqxcnhe uob Shrrzjmlyrm Bfuhflvy Gxoy Bad Bentheim Germany

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
20.11.2023
Germany Germany
Not recruiting
20.11.2023
Hungary Hungary
Not recruiting
20.11.2023
Italy Italy
Not recruiting
20.11.2023
Poland Poland
Not recruiting
20.11.2023
Spain Spain
Not recruiting
20.11.2023

Trial locations

Investigated drugs:

JNJ-77242113 is a medication being studied for its potential to help people with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches to appear on the skin. This medication is designed to target specific parts of the immune system that are thought to play a role in causing these skin changes. By doing so, it may help reduce the symptoms of psoriasis, such as redness and scaling, and improve the overall appearance of the skin. The study aims to see how well this medication works and how safe it is for people with this condition.

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 on the skin. These patches, known as 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 exact cause of plaque psoriasis is not fully understood, but it involves an overactive immune response that accelerates skin cell production. Environmental factors, stress, and certain triggers can exacerbate the condition, leading to more frequent or severe flare-ups.

Trial ID:
2023-505120-59-00
Protocol code:
77242113PSO3001
Trial Phase:
Therapeutic confirmatory (Phase III)

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