Efficacy and Safety Evaluation of JNJ-77242113 Versus Placebo and Deucravacitinib in Moderate to Severe Plaque Psoriasis: A Phase 3 Randomized Controlled Trial

The primary objective of this Phase 3 multicenter, randomized, double-blind, placebo-controlled, and **deucravacitinib** active comparator-controlled study is to evaluate the efficacy of **JNJ-77242113** compared with placebo in participants with moderate to severe plaque psoriasis. This objective is clinically relevant as it aims to determine the therapeutic potential of JNJ-77242113 in improving the condition of patients suffering from this chronic inflammatory skin disease, which can significantly impact quality of life.

The clinical trial involves a total of **422 participants** diagnosed with **moderate to severe plaque psoriasis**. The study population includes both male and female subjects, aged 18 years and older, who have been living with the condition for at least 26 weeks prior to the first administration of the study intervention. Participants were selected based on specific criteria, including a total Body Surface Area (BSA) of 10% or greater, a Psoriasis Area and Severity Index (PASI) score of 12 or higher, and an Investigator's Global Assessment (IGA) score of 3 or more at both screening and baseline. The trial does not exclude vulnerable populations, indicating a diverse participant group. Lifestyle factors such as diet, physical activity, and habits were not specified in the available data.

The clinical trial is a **Phase 3**, multicenter, randomized, double-blind, placebo-controlled, and active comparator-controlled study designed to evaluate the efficacy and safety of **JNJ-77242113** in participants with moderate to severe plaque psoriasis. The trial will involve a comparison between JNJ-77242113, a placebo, and an active comparator, **deucravacitinib**. The study is expected to commence recruitment on February 1, 2024, and conclude by June 15, 2027. Participants will be randomly assigned to receive either JNJ-77242113, deucravacitinib, or a placebo, with all interventions administered orally in the form of film-coated tablets.

The trial will include several key visits: an initial screening visit, regular follow-up visits, and an end-of-study visit. During the screening visit, eligibility will be assessed based on criteria such as age (≥18 years), a confirmed diagnosis of plaque psoriasis for at least 26 weeks, and specific baseline disease severity measures (e.g., total BSA ≥10%, PASI ≥12, IGA ≥3). Participants will be monitored throughout the study with follow-up visits to assess the primary endpoints, which include achieving an IGA score of 0 or 1 with a ≥2-grade improvement from baseline and a PASI 90 response at Week 16. The end-of-study visit will evaluate the overall safety and efficacy outcomes.

The expected duration of participant involvement is up to 156 weeks, depending on the treatment group assignment. Conditions that may lead to early termination from the study include adverse events, withdrawal of consent, or non-compliance with study procedures. The trial is not classified as low intervention, and it aims to provide robust data on the therapeutic potential of JNJ-77242113 in treating moderate to severe plaque psoriasis.

The clinical trial involves the administration of **DEUCRAVACITINIB**, an experimental medication formulated as a film-coated tablet. This chemical-based active substance is administered orally. The tablets are commercially available and will be supplied as over-encapsulated capsules. The maximum treatment period for DEUCRAVACITINIB is 24 weeks. The dosage and frequency of administration are not specified in the provided data, and participant compliance will be monitored throughout the study.

**JNJ-77242113** is another experimental medication used in this trial, also formulated as a film-coated tablet. This peptide-based active substance is administered orally. The maximum treatment period for JNJ-77242113 is 156 weeks. The dosage and frequency of administration are not specified in the provided data, and participant compliance will be monitored throughout the study. JNJ-77242113 is produced by Janssen-Cilag International N.V.

The study includes a placebo group, which will receive a film-coated tablet without the active substance DEUCRAVACITINIB. The placebo is designed to match the experimental medication in appearance but does not contain the active ingredient. The administration route and frequency are consistent with the experimental treatments, ensuring blinding and maintaining the integrity of the study design.

Additionally, another placebo group will receive a film-coated tablet without the active substance JNJ-77242113. Similar to the other placebo, this tablet is designed to match the experimental medication in appearance but lacks the active ingredient. The administration route and frequency are consistent with the experimental treatments, ensuring blinding and maintaining the integrity of the study design.

The efficacy of JNJ-77242113 in the treatment of moderate to severe plaque psoriasis will be assessed in a Phase 3 multicenter, randomized, double-blind, placebo-controlled, and **deucravacitinib** active comparator-controlled study. The primary endpoints for evaluating efficacy include achieving an Investigator's Global Assessment (IGA) score of 0 or 1 with a ≥2-grade improvement from baseline at Week 16, and achieving a Psoriasis Area and Severity Index (PASI) 90 at Week 16. These endpoints will be measured at specific timepoints, with the primary assessment occurring at Week 16. The IGA and PASI are validated scales commonly used in clinical trials to assess the severity and extent of psoriasis, providing a standardized method for evaluating treatment efficacy. The study will involve the administration of JNJ-77242113 in the form of film-coated tablets, with the treatment period extending up to 156 weeks. The trial aims to provide robust data on the efficacy of JNJ-77242113 compared to placebo and deucravacitinib in improving clinical outcomes for participants with moderate to severe plaque psoriasis.