Efficacy and Safety Evaluation of JNJ-77242113 in Moderate to Severe Plaque Psoriasis Affecting Special Areas: A Phase 3 Randomized, Double-blind, Placebo-controlled Study

The primary objective of this Phase 3 multicenter, randomized, double-blind, placebo-controlled study is to evaluate the **efficacy** of JNJ-77242113 in participants with **plaque psoriasis**. The study specifically targets individuals with at least moderate severity affecting special areas or those with moderate to severe plaque psoriasis involving a body surface area (BSA) ranging from 5% to less than 10%. This objective is clinically relevant as it aims to address the therapeutic needs of patients with psoriasis in challenging areas, potentially improving their quality of life and disease management.

The clinical trial involves a total of **154 participants** diagnosed with **plaque psoriasis**, with or without psoriatic arthritis, for at least 26 weeks prior to the study intervention. The study population includes both male and female subjects, aged 12 years and older, who are candidates for phototherapy or systemic treatment. Participants were selected based on their moderate to severe plaque psoriasis affecting special areas or with a body surface area (BSA) ranging from 5% to less than 10%. The trial includes individuals who have failed to respond to at least one topical therapy for psoriasis. The study population is characterized by a diverse age range and includes vulnerable populations. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is a **Phase 3**, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of the investigational product **JNJ-77242113** in participants with **plaque psoriasis**. The trial aims to assess the treatment's impact on individuals with at least moderate severity affecting special areas or lower body surface area (BSA) ranging from 5% to less than 10%. The study is expected to commence recruitment on November 20, 2023, and conclude by March 31, 2027, with a total duration of approximately 156 weeks for each participant.

Participants will be randomly assigned to receive either the active treatment, JNJ-77242113, in the form of a film-coated tablet, or a placebo. The trial will follow a double-blind design, ensuring that neither the participants nor the investigators are aware of the treatment allocations. The primary endpoint is to achieve an Investigator's Global Assessment (IGA) score of 0 or 1 with a minimum two-grade improvement from baseline at Week 16.

The sequence of study visits includes an initial screening visit to confirm eligibility based on criteria such as age (≥12 years), diagnosis of plaque psoriasis for at least 26 weeks, and previous failure to respond to at least one topical therapy. Following the screening, participants will undergo regular follow-up visits to monitor safety and efficacy outcomes. The end-of-study visit will mark the completion of the participant's involvement in the trial.

Participant involvement is expected to last for the entire duration of the trial unless early termination is warranted. Conditions that may lead to early withdrawal include adverse events, non-compliance with the study protocol, or withdrawal of consent. The trial is not categorized as low intervention, and the investigational product is not an orphan drug. The study is conducted under the sponsorship of Janssen-Cilag International N.V., with the investigational product being administered orally.

The clinical trial involves the administration of the experimental medication **JNJ-77242113**, which is formulated as a **film-coated tablet**. This investigational product is designed for **oral use**. The active substance, JNJ-77242113, is a protein-based compound categorized under "Protein - Other." The trial does not specify a maximum daily dose or total dose amount, but the maximum treatment period is set at 156 days. The pharmaceutical form is provided by Janssen-Cilag International N.V., and the medication is not a pediatric formulation. The study aims to evaluate the efficacy and safety of JNJ-77242113 in participants with **plaque psoriasis** affecting special areas.

In addition to the experimental treatment, the study includes a **placebo** group. The placebo is also presented as a film-coated tablet but does not contain the active substance JNJ-77242113. The placebo serves as a comparator to assess the efficacy of the experimental medication. The administration route and frequency for the placebo are consistent with those of the experimental treatment to maintain the double-blind nature of the study. Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the protocol.

The efficacy of JNJ-77242113 in the treatment of **plaque psoriasis** will be assessed in a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary endpoint for evaluating efficacy is the Investigator's Global Assessment (IGA) score, specifically achieving an IGA (overall) score of 0 or 1, along with a ≥2-grade improvement from baseline at Week 16. This endpoint will be measured using a validated scale to ensure consistency and reliability in the assessment of symptom improvement.