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Study on the Effectiveness and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab for Patients with Moderate to Severe Plaque Psoriasis

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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 moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. The study will compare a new medication, known by its code name JNJ-77242113, with a commonly used treatment called Ustekinumab and a placebo. The purpose of the study is to evaluate how well JNJ-77242113 works in treating this condition.

Participants in the study will receive either the new medication, Ustekinumab, or a placebo. The new medication, JNJ-77242113, is taken as a film-coated tablet, while Ustekinumab is given as an injection. The study will last for several weeks, during which participants will be monitored to see how their psoriasis responds to the treatment. The goal is to see if the new medication can improve the symptoms of psoriasis, such as reducing the size and severity of the skin patches.

The study will involve regular check-ups to assess the condition of the skin and overall health. Participants will be randomly assigned to one of the treatment groups, and neither the participants nor the researchers will know which treatment is being given to ensure unbiased results. The study aims to provide valuable information on whether JNJ-77242113 is a safe and effective option for treating moderate to severe plaque psoriasis.

1 joining the study

Upon joining the study, participants will be informed about the trial’s purpose, which is to evaluate the effectiveness of a new medication called JNJ-77242113 for treating moderate to severe plaque psoriasis.

Participants will be randomly assigned to receive either the new medication, a placebo (a substance with no active medication), or an existing treatment called ustekinumab.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility, which includes being at least 12 years old and having a diagnosis of moderate to severe plaque psoriasis for at least 26 weeks.

The assessment will also check the extent of the skin condition, ensuring a body surface area (BSA) of at least 10% and a psoriasis area and severity index (PASI) score of at least 12.

3 treatment phase

Participants will begin the treatment phase, which involves taking the assigned medication.

Those receiving JNJ-77242113 will take it orally in the form of a film-coated tablet. The specific dosage and frequency will be provided by the study team.

Participants assigned to ustekinumab will receive it as a subcutaneous injection, which means it is injected under the skin. The dosage will be either 45 mg or 90 mg, depending on the participant’s group.

4 monitoring and follow-up

Throughout the study, participants will have regular follow-up visits to monitor their health and the effectiveness of the treatment.

These visits will include assessments of the skin condition and any side effects experienced. The goal is to achieve an improvement in the skin condition, measured by a reduction in the PASI score and an improvement in the investigator’s global assessment (IGA) score.

5 end of study evaluation

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

The study aims to achieve significant improvement in the skin condition by week 16, as measured by specific clinical endpoints.

Who Can Join the Study?

  • Must be at least 12 years old at the time of the screening visit.
  • Must have a diagnosis of moderate to severe plaque psoriasis for at least 26 weeks before the first study treatment. Psoriasis is a skin condition that causes red, scaly patches.
  • Must have a Body Surface Area (BSA) affected by psoriasis of at least 10% at screening and baseline. BSA is a way to measure the total area of the body affected by psoriasis.
  • Must have a PASI score of at least 12 at screening and baseline. PASI stands for Psoriasis Area and Severity Index, which measures the severity of psoriasis.
  • Must have an IGA score of at least 3 at screening and baseline. IGA stands for Investigator’s Global Assessment, which 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 cannot participate.
  • Patients who have had a recent infection or are currently experiencing an infection are not eligible.
  • Patients who have received certain treatments for psoriasis recently, such as biologics or systemic therapies, are excluded.
  • Patients with a history of certain serious diseases, like cancer or heart disease, cannot take part.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients who have participated in another clinical trial recently are not eligible.
  • Patients with a known allergy to any of the study medications or similar drugs cannot join the study.
  • Patients with a history of drug or alcohol abuse may be excluded.
  • Patients who are unable to comply with the study procedures or follow-up visits are not eligible.

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
Hospital Universitario Y Politecnico La Fe Valencia Spain
Dermed Centrum Medyczne Sp. z o.o. Lodz Poland
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik Bialystok Poland
Medical University Of Vienna Vienna Austria
Vasarhelyi Sarkanyfu Kft. Hodmezovasarhely Hungary
Katholieke Universiteit te Leuven Leuven Belgium
Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy M. Brzewski, P. Brzewski S.C. Cracow Poland
Studienzentrum Dr. Beate Schwarz Langenau Germany

Other Sites

Site Name City Country Status
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Specderm Poznanska Sp. j. Bialystok Poland
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Cuf Descobertas S.A. Lisbon Portugal
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Hospital Marina Baixa De La Vila Joiosa Villajoyosa Spain
Solumed Sp. z o.o. sp.k. Poznan Poland
Centrum Medyczne Oporow Wroclaw Poland
Rosenpark Research GmbH Darmstadt Germany
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Derma-B Kft. Debrecen Hungary
Klinika Ambroziak Sp. z o.o. Warsaw Poland
ISA Interdisciplinary Study Association GmbH Berlin Germany
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR Blankenfelde-Mahlow Germany
Derma-Study-Center Friedrichshafen GmbH Friedrichshafen Germany
Wromedica I Bielicka A Strzalkowska s.c. Wroclaw Poland
Carpe Diem Centrum Medycyny Estetycznej Warsaw Poland
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. Olsztyn Poland
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
University Of Debrecen Debrecen Hungary
Clinmedica Research sp. z o.o. Skierniewice Poland
Odense University Hospital Odense Denmark
Hospital Clinic De Barcelona Barcelona Spain
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH Feldkirch Austria
Hospital Universitario De Cruces Barakaldo Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Aalborg University Hospital Aalborg Denmark
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Hospital Universitario Virgen De Valme Sevilla Spain
Klinik Hietzing Vienna Austria
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Gentofte Hospital Hellerup Denmark
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Allergo-Derm Bakos Kft. Szolnok Hungary
Care Clinic Sp. z o.o. Katowice Poland
Medmare Bt. Veszprem Hungary
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Elblag Poland
Hcmwboqn Uhxeuimdkyjyu Dr Lx Piknpkro Madrid Spain
Uiraglzhpvbtfevhxrgll Apmwuead Augsburg Germany
Tpcvueggout uyq Sdnjcvuvewy Bylyqgij Gfjp Bad Bentheim Germany
Bjqzzqylzjb Vkfshwjgf Osbbxxcapopl Kecskemet Hungary
Hivnpp Hncmtcvh Herlev Denmark
Aaskdy Updxljbvjt Hbevlyqa Aarhus Denmark
Ulaatennvjvbeaqdekdtr Mvevwjih Aif Munster Germany
Jjypnopx Kbcqoj Utvtmdsfcj Linz Austria
Hfgfsdrgzluiha Du Mrx Mfjvyzmd Hgewcppp Witten Germany
Sbejehnexkljpp ar dvs Hgwu Grb Bramsche Germany
Dbeypmfjmwzp Qdmlf Mainz Germany
Utx Mzepklv Tvncij Kudj Budapest Hungary

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
12.05.2025
Belgium Belgium
Not recruiting
12.05.2025
Denmark Denmark
Not recruiting
12.05.2025
Germany Germany
Not recruiting
12.05.2025
Hungary Hungary
Not recruiting
12.05.2025
Poland Poland
Not recruiting
12.05.2025
Portugal Portugal
Not recruiting
12.05.2025
Spain Spain
Not recruiting
12.05.2025

Trial locations

Investigated drugs:

JNJ-77242113 is an experimental medication being tested to see how well it works for people with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin. This medication is being studied to understand if it can help reduce these symptoms and improve the skin’s appearance.

Ustekinumab is a medication already used to treat moderate to severe plaque psoriasis. It works by targeting specific proteins in the immune system that are involved in causing the skin symptoms. In this study, Ustekinumab is used as a comparison to see how well the new medication, JNJ-77242113, performs against a known treatment.

Moderate to Severe 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, or plaques, are often itchy and can appear anywhere on the body, but are most commonly found on the elbows, knees, scalp, and lower back. The disease progresses through cycles, with periods of increased activity (flare-ups) followed by times of remission. During flare-ups, the plaques can become more inflamed and widespread. The severity of the condition can vary, with moderate to severe cases involving more extensive skin coverage and more significant impact on quality of life. The exact cause of plaque psoriasis is not fully understood, but it involves a combination of genetic and environmental factors.

Trial ID:
2024-515706-77-00
Protocol code:
77242113PSO3006
Trial Phase:
Therapeutic confirmatory (Phase III)

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