Efficacy and Safety of Guselkumab Versus Etanercept in Pediatric Chronic Plaque Psoriasis: A Randomized, Placebo-Controlled Phase 3 Trial

The primary objective of this study is to evaluate the **efficacy** and **safety** of subcutaneously administered **guselkumab** in pediatric participants aged 6 to less than 18 years with **chronic plaque psoriasis**. This is clinically relevant as it aims to address the therapeutic needs of a younger population suffering from this chronic inflammatory skin condition, potentially improving their quality of life and disease management.

The clinical trial involves a total of **20 participants** diagnosed with **chronic plaque psoriasis**. The study population consists of pediatric participants aged **6 through 17 years**, inclusive of both **male and female** subjects. Participants were selected based on their diagnosis of chronic plaque-type psoriasis for at least six months, with specific criteria regarding the severity and extent of the condition. The trial includes individuals who are candidates for phototherapy or systemic treatment and those whose condition is inadequately controlled with existing therapies. Participants are required to be otherwise healthy, with any abnormalities being consistent with the underlying illness. Additionally, participants must have acceptable evidence of immunity to varicella and measles, mumps, and rubella (MMR). The trial population includes a vulnerable group, given the pediatric nature of the participants. Lifestyle considerations such as diet and physical activity are not specified in the available data.

The clinical trial is a **randomized**, double-blind, placebo- and active comparator-controlled study designed to evaluate the efficacy, safety, and pharmacokinetics of **guselkumab** in pediatric participants aged 6 to less than 18 years with **chronic plaque psoriasis**. The trial is structured to include multiple phases over an estimated duration of 52 weeks. Participants will be randomly assigned to receive either guselkumab, **etanercept**, or a placebo, administered via **subcutaneous use**. The primary endpoint is the proportion of participants achieving a PASI 75 response at Week 16.

The sequence of study visits begins with an inclusion (screening) visit, where eligibility is assessed based on criteria such as a diagnosis of chronic plaque-type psoriasis for at least six months, and the participant's candidacy for phototherapy or systemic treatment. Following the screening, participants will undergo baseline assessments before the first administration of the study intervention. Subsequent follow-up visits will occur at regular intervals to monitor safety, efficacy, and pharmacokinetics, with the final visit marking the end of the study.

Participant involvement is expected to last for the full 52-week duration unless early termination is warranted. Conditions that may lead to early termination include adverse events, withdrawal of consent, or any situation where continued participation is deemed not in the participant's best interest by the investigator. The trial is conducted in compliance with ethical standards and regulatory requirements, ensuring the safety and well-being of all participants throughout the study period.

The clinical trial involves the administration of **Guselkumab**, a monoclonal antibody, as the primary experimental treatment. Guselkumab is provided as a solution for injection in a pre-filled syringe, with a concentration of 100 mg/mL. The administration route is subcutaneous, and the treatment is scheduled for a maximum period of 52 weeks. The dosing regimen and frequency are determined based on the study protocol, and participant compliance is monitored throughout the trial. The device used for administration is the 1 mL UltraSafe Plus™ Passive Needle Guard, which facilitates manual injection and ensures safety post-delivery.

**Enbrel**, containing the active substance **Etanercept**, is used as a comparator treatment in the study. It is available in two formulations: a 25 mg powder and solvent for solution for injection, and a 50 mg solution for injection in a pre-filled syringe. Both formulations are administered subcutaneously. The maximum treatment period for Enbrel is 16 weeks. The commercial Enbrel products are repackaged with clinical labels and sealed with a tamper-evident seal for use in the trial.

Two placebo formulations are included in the study: Guselkumab 0.5 mL Varioject Placebo and Guselkumab 1 mL PFS Placebo. These placebos are used to maintain blinding and assess the efficacy of the experimental treatment. The placebo formulations do not contain any active substances and are administered according to the same schedule as the active treatments.

The efficacy of the clinical trial will be assessed by evaluating the primary endpoint, which is the proportion of participants achieving a **Psoriasis Area and Severity Index (PASI) 75** response at Week 16. This endpoint measures the percentage of participants who experience at least a 75% improvement in their PASI score from baseline, indicating a significant reduction in the severity and extent of **chronic plaque psoriasis**. The PASI score is a widely used tool in dermatology to quantify the severity of psoriasis based on the area of skin affected and the degree of plaque redness, thickness, and scaling.

Data collection for the PASI 75 response will occur at the specified timepoint of Week 16. The analysis will involve comparing the proportion of participants achieving the PASI 75 response in the treatment group receiving **guselkumab** against those in the placebo and active comparator groups. This comparison will help determine the efficacy of guselkumab in treating pediatric participants with chronic plaque psoriasis. The trial is designed to ensure that the efficacy assessments are conducted in a standardized manner, using validated scales and methodologies to ensure the reliability and accuracy of the results.