A Phase 3 Study to Evaluate the Efficacy and Safety of JNJ-77242113 in Participants With Moderate to Severe Plaque Psoriasis Compared to Deucravacitinib or Placebo

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 potential of JNJ-77242113 to improve 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 **356 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 diagnosed with plaque psoriasis, with or without psoriatic arthritis, 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 involvement of 10% or more, 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 screening and baseline. The trial includes a vulnerable population, and lifestyle factors such as diet and physical activity were not specified by the sponsor. The selection process ensures a representative sample of individuals affected by this condition, allowing for a comprehensive evaluation of the efficacy of JNJ-77242113 compared with placebo.

The clinical trial is designed as a **randomized**, **double-blind**, **placebo-controlled**, and active comparator-controlled study to evaluate the efficacy and safety of JNJ-77242113 in participants with moderate to severe **plaque psoriasis**. The trial will involve multiple study visits over an estimated duration of 156 weeks. Participants will be randomly assigned to receive either JNJ-77242113, a placebo, or an active comparator, Deucravacitinib, all administered orally in the form of film-coated tablets. The primary objective is to assess the efficacy of JNJ-77242113 compared to placebo, with primary endpoints including an Investigator's Global Assessment (IGA) score of 0 or 1 and a ≥2-grade improvement from baseline at Week 16, as well as a Psoriasis Area and Severity Index (PASI) 90 at Week 16.

The sequence of study visits begins with an inclusion (screening) visit, where participants are assessed for eligibility based on criteria such as age (≥18 years), diagnosis of plaque psoriasis for at least 26 weeks, and specific baseline scores for BSA, PASI, and IGA. Following successful screening, participants will undergo randomization and commence the treatment phase. Follow-up visits will be scheduled at regular intervals to monitor safety, efficacy, and adherence to the study protocol. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to evaluate the long-term effects of the treatment.

Participant involvement is expected to last for the full duration of the trial, approximately 156 weeks, unless early termination is warranted. Conditions that may lead to early termination include adverse events, non-compliance with the study protocol, or withdrawal of consent by the participant. The trial is not categorized as low intervention and is conducted under strict regulatory and ethical guidelines to ensure the safety and well-being of all participants.

The clinical trial involves the evaluation of the **experimental medication** JNJ-77242113, which is administered in the form of a **film-coated tablet**. The active substance, JNJ-77242113, is a peptide with a protein origin. The pharmaceutical form is specifically designed for **oral use**. The trial does not specify a maximum daily dose or total dose amount, and the treatment period extends up to 156 weeks. The medication is provided by Janssen-Cilag International N.V. and is not formulated for pediatric use. Participant compliance with the dosing schedule will be monitored throughout the trial.

In addition to the experimental medication, the study includes a **comparator treatment** with Deucravacitinib, which is also administered as a film-coated tablet for oral use. Deucravacitinib is a chemical substance, and the commercially available tablets are supplied as over-encapsulated capsules. The maximum treatment period for Deucravacitinib is 24 weeks. This comparator treatment is not intended for pediatric use, and participant adherence to the dosing regimen will be closely monitored.

The trial also incorporates a **placebo** control, which is administered in the form of a film-coated tablet without the active substances JNJ-77242113 or Deucravacitinib. The placebo is used to maintain the double-blind nature of the study, ensuring unbiased assessment of the efficacy and safety of the experimental medication. The placebo tablets are identical in appearance to the active treatments to ensure blinding is maintained throughout the trial.

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 are designed to measure significant improvements in the severity and extent of psoriasis symptoms.