Efficacy and Safety Evaluation of JNJ-77242113 Versus Placebo and Ustekinumab 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 Ustekinumab 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 and debilitating skin disease, which can significantly impact quality of life. The study will provide insights into the therapeutic benefits of JNJ-77242113, potentially offering a new treatment option for patients who do not respond adequately to existing therapies.

The clinical trial involves a total of **273 participants** diagnosed with **moderate to severe plaque psoriasis**. The study population includes both male and female subjects, aged 12 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 includes a vulnerable population, and the selection process ensures a representative sample of individuals affected by this chronic skin condition. 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 **Ustekinumab** active comparator-controlled study designed to evaluate the efficacy and safety of **JNJ-77242113** for the treatment of participants with moderate to severe plaque psoriasis. The trial aims to assess the efficacy of JNJ-77242113 compared with 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 trial is expected to commence recruitment on May 12, 2025, and conclude by December 29, 2027.

Participants will be involved in the study for a maximum treatment period of 104 weeks. The trial includes a screening visit to confirm eligibility, based on criteria such as age (≥12 years), diagnosis of moderate to severe plaque psoriasis for at least 26 weeks, and specific baseline scores for BSA, PASI, and IGA. Following the screening, participants will be randomized to receive either JNJ-77242113, placebo, or Ustekinumab. The study will involve regular follow-up visits to monitor efficacy and safety, with assessments conducted at specified intervals, including the primary endpoint evaluation at Week 16. The end-of-study visit will occur at the conclusion of the treatment period or upon early termination.

Participants may be withdrawn from the study if they experience adverse events that compromise safety, fail to adhere to the study protocol, or if the investigator deems it necessary for any other reason. The trial is structured to ensure rigorous assessment of the investigational product's efficacy and safety, with a focus on maintaining the integrity of the double-blind design throughout the study duration.

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 protein of other origin, developed by Janssen-Cilag International N.V. The pharmaceutical form is specified as a film-coated tablet, intended for **oral use**. The maximum treatment period for this medication is 104 weeks. The dosage and frequency of administration are not explicitly detailed in the provided data.

In addition to the experimental medication, the study includes a **comparator treatment** using STELARA, which contains the active substance **Ustekinumab**. STELARA is available in two formulations: a 90 mg solution for injection in a pre-filled syringe and a 45 mg solution for injection. Both formulations are administered via **subcutaneous use**. The maximum treatment period for STELARA is 28 weeks. The pharmaceutical form for the 90 mg dose is a solution for injection in a pre-filled syringe, while the 45 mg dose is a solution for injection. Janssen-Cilag International NV is the manufacturer of STELARA.

The trial also includes **placebo treatments**. These are represented by a film-coated tablet without JNJ-77242113 and a solution for injection without Ustekinumab 45 or 90. The pharmaceutical forms and routes of administration for these placebo treatments are not specified in the provided data.

Participant compliance with the dosing schedule will be monitored throughout the trial, although specific methods for compliance monitoring are not detailed in the provided data. The trial is designed to assess the efficacy and safety of JNJ-77242113 in comparison to placebo and the active comparator, STELARA, in participants with moderate to severe plaque psoriasis.

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 Ustekinumab 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.

The study will involve the administration of JNJ-77242113, a film-coated tablet, and will compare its efficacy against a placebo and Ustekinumab, a solution for injection. The efficacy assessments will be conducted at specific timepoints, with the primary evaluation occurring at Week 16. The trial aims to provide a comprehensive evaluation of the treatment's impact on the participants' psoriasis condition, using validated scales such as the IGA and PASI to ensure reliable and consistent measurement of outcomes.