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

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What is this study about?

This clinical trial is focused on studying the treatment of moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches on the skin. The study will evaluate a new medication called JNJ-77242113, which is taken as a film-coated tablet. The purpose of the study is to assess how effective and safe this medication is compared to a placebo and another medication called Deucravacitinib, which is already used to treat psoriasis.

Participants in the study will be randomly assigned to receive either the new medication, the placebo, or Deucravacitinib. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps ensure that the results are unbiased. The study will take place over several weeks, during which participants will take the medication orally and attend regular check-ups to monitor their progress and any side effects.

The goal is to determine if JNJ-77242113 can improve the symptoms of plaque psoriasis more effectively than the placebo or Deucravacitinib. Participants will be monitored for changes in their skin condition and overall health. The study aims to provide valuable information that could lead to new treatment options for people living with moderate to severe plaque psoriasis.

1 joining the study

Upon joining the study, the participant is confirmed to meet the inclusion criteria, which include being 18 years or older, having a diagnosis of plaque psoriasis for at least 26 weeks, and meeting specific severity criteria for the condition.

2 randomization

Participants are randomly assigned to one of the study groups. This process is double-blind, meaning neither the participants nor the researchers know which treatment the participant is receiving.

3 treatment phase

Participants receive either the investigational drug JNJ-77242113, a placebo, or the active comparator Deucravacitinib. Both medications are administered as film-coated tablets taken orally.

The dosage and frequency of administration are determined by the study protocol, which is not specified in the provided data.

4 monitoring and assessments

Throughout the study, participants undergo regular assessments to monitor the efficacy and safety of the treatment. This includes evaluating the severity of psoriasis using standardized scoring systems.

5 end of treatment evaluation

At the end of the treatment period, participants are evaluated to determine the primary outcomes, which include achieving a specific improvement in psoriasis severity scores by Week 16.

6 follow-up

Participants may be required to attend follow-up visits to monitor any long-term effects of the treatment.

Who Can Join the Study?

  • Must be at least 18 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 on the skin.
  • Must have a Body Surface Area (BSA) affected by psoriasis of at least 10% at screening and at the start of the study. BSA is a way to measure how much of the body is affected by psoriasis.
  • Must have a PASI score of at least 12 at screening and at the start of the study. PASI stands for Psoriasis Area and Severity Index, which is a tool used to measure the severity of psoriasis.
  • Must have an IGA score of at least 3 at screening and at the start of the study. IGA stands for Investigator’s Global Assessment, which is a scale used to assess the overall severity of psoriasis.

Who Cannot Join the Study?

  • Having any other skin conditions that might interfere with the study results.
  • Having a history of allergic reactions to similar medications.
  • Currently participating in another clinical trial.
  • Having a serious infection or illness that requires treatment.
  • Being pregnant or planning to become pregnant during the study.
  • Having a history of certain heart conditions.
  • Using certain medications that might interfere with the study.
  • Having a history of drug or alcohol abuse.
  • Having a weakened immune system, which means the body’s defense against infections is not strong.
  • Having received certain vaccines recently.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Klinikum Oldenburg AöR Oldenburg In Holstein Germany
Fondazione Luigi Maria Monti Rome Italy
Azienda Unita Locale Socio Sanitaria N 8 Berica Vicenza Italy
Spitalul Clinic Judetean De Urgenta Craiova Craiova Romania
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Hospital Marina Baixa De La Vila Joiosa Villajoyosa Spain
Dr. Niesmann And Dr. Othlinghaus GbR Bochum Germany
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. Olsztyn Poland
Wromedica I Bielicka A Strzalkowska s.c. Wroclaw Poland
Renew Clinic Sp. z o.o. Bialystok Poland
Carpe Diem Centrum Medycyny Estetycznej Warsaw Poland
Hms GmbH Merzig Germany
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR Blankenfelde-Mahlow Germany
Derma-Study-Center Friedrichshafen GmbH Friedrichshafen Germany
Klinikum Darmstadt GmbH Darmstadt Germany
Jagiellońskie Centrum Innowacji Sp. z o.o. Cracow Poland
Spitalul Clinic Judetean De Urgenta Bihor Oradea Romania
CRS Clinical Research Services Management GmbH Berlin Germany
ProDerma Duelmen Germany
Hospital Clinic De Barcelona Barcelona Spain
Universita’ Politecnica Delle Marche Ancona Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Eurofins bioskin GmbH Hamburg Germany
Synexus Polska Sp. z o.o. Poznan Poland
Hospital Universitario Virgen De Valme Sevilla Spain
Spitalul Clinic Judetean Mures Targu Mures Romania
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Universita Degli Studi Di Brescia Brescia Italy
Care Clinic Sp. z o.o. Katowice Poland
Iasiprest S.R.L. Iasi Romania
University Hospital Consorziale Policlinico Bari Italy
Prywatny Gabinet Dermatologiczny Elzbieta Klujszo Kielce Poland
Royalderm Agnieszka Nawrocka Warsaw Poland
Hautarztpraxis Dr. Hoffmann Witten Germany
Privatpraxis Dr. Hilton & Partner Duesseldorf Germany
Hautarztpraxis Dr. Mihaescu Augsburg Germany
Teqtrnkafac unf Sdpedjqafrb Bigczaws Gkti Bad Bentheim Germany
Vdyqzjse Myhhyor Shqist Craiova Romania
Klfyygpzif Cieuluz Bpkst Ktggrpnhjjq Sby z osue Cracow Poland
Bmelodirwtu Vvthdeffe Oqciaqxozfyb Kecskemet Hungary
Aouvemc Omqkuccmlrx Ujussojmxocal Ssxfir Siena Italy
Alcvpta Ozsfdhmympa Uycpwnnjaspim Cgrmycnlckqr Dlnbw Sfgckf E Dihtr Sfmiyuc Da Thkduf Turin Italy
Upkalrxbqrulxpgqjctef Mkeqmlgg Agj Munster Germany
Pypdrhn Sve z ootc Katowice Poland
Hwknhzcm Uoxsiubxdjzoo Hazvrwvz Thtuo y Pbxgwn Icujccey Cauwst dvukzvhaurcjloymy (ktlm Badalona Spain
Uds Mtrhksy Tprbvj Kssg Budapest Hungary

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

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.04.2024
Hungary Hungary
Not recruiting
01.04.2024
Italy Italy
Not yet recruiting
01.04.2024
Poland Poland
Not recruiting
01.04.2024
Romania Romania
Not recruiting
01.04.2024
Spain Spain
Not recruiting
01.04.2024

Trial locations

JNJ-77242113 is an investigational medication being studied for its effectiveness in treating moderate to severe plaque psoriasis. This medication is being compared to a placebo to determine how well it works in reducing the symptoms of psoriasis, which is a skin condition that causes red, scaly patches.

Deucravacitinib is an active comparator in this study. It is a medication that is already used to treat moderate to severe plaque psoriasis. The study aims to compare the effectiveness and safety of JNJ-77242113 against Deucravacitinib to see if the new medication offers any advantages.

Moderate to Severe Plaque Psoriasis – This is a chronic skin condition characterized by red, scaly patches that can appear anywhere on the body. The patches, known as plaques, are often itchy and can be painful. The disease occurs when skin cells multiply faster than normal, leading to a buildup of cells on the skin’s surface. These plaques can vary in size and may join together to form larger areas. The condition can fluctuate, with periods of improvement and worsening. It is not contagious and can affect individuals differently, with some experiencing more severe symptoms than others.

Trial ID:
2023-507039-39-00
Protocol code:
77242113PSO3004
Trial Phase:
Therapeutic confirmatory (Phase III)

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