Efficacy and Safety Evaluation of JNJ-77242113 in Biologic-naïve Patients with Active Psoriatic Arthritis: 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 at doses of 200 mg and 400 mg compared to placebo in biologic-naïve participants with active **Psoriatic Arthritis** (PsA). The assessment focuses on the reduction of signs and symptoms of PsA at Week 16. This is clinically relevant as it aims to provide an effective treatment option for patients who have not previously received biologic therapies, potentially improving their quality of life by alleviating the symptoms associated with PsA.

The clinical trial involves a total of **210 participants** diagnosed with **Active Psoriatic Arthritis**. The study population includes both male and female subjects, aged 18 years and older, who have been diagnosed with Psoriatic Arthritis for at least three months prior to the study. Participants were selected based on specific criteria, including having active Psoriatic Arthritis as evidenced by at least three swollen and tender joints, and a C-reactive protein level of 0.1 mg/dL or higher. The trial includes individuals with various PsA subsets, such as distal interphalangeal joint involvement and asymmetric peripheral arthritis. Participants are required to have active plaque psoriasis and must be suitable candidates for treatment with ustekinumab. The study considers lifestyle factors such as the use of non-biologic DMARDs, apremilast, NSAIDs, and oral corticosteroids, with specific requirements for stability and dosage prior to the administration of the study intervention. The trial does not exclude vulnerable populations, ensuring a comprehensive evaluation of the treatment's efficacy across a diverse group of individuals.

The clinical trial is a **Phase 3**, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of JNJ-77242113 in biologic-naïve participants with active **psoriatic arthritis**. The primary objective is to assess the reduction in signs and symptoms of psoriatic arthritis by comparing JNJ-77242113 at doses of 200 mg and 400 mg against a placebo at Week 16. The trial is expected to commence recruitment on May 1, 2025, and conclude by November 21, 2028, with a total duration of approximately 3.5 years.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age, diagnosis, and disease activity. The trial will include multiple follow-up visits to monitor the participants' response to the treatment and any adverse effects. The primary endpoint is the American College of Rheumatology (ACR) 20 response at Week 16. The end-of-study visit will occur after the completion of the treatment period, which may last up to 100 weeks, depending on the treatment arm.

Participant involvement is expected to last for the duration of the treatment period, with conditions for early termination including significant adverse events, withdrawal of consent, or non-compliance with the study protocol. The study will utilize both JNJ-77242113 and a placebo, with the active treatment administered orally in the form of film-coated tablets. The trial will ensure that all participants meet the inclusion criteria, such as having active psoriatic arthritis and being suitable candidates for treatment with **ustekinumab** as per local labeling. The study will adhere to rigorous standards to maintain the integrity and reliability of the data collected throughout the trial.

The clinical trial involves the administration of several treatments, including **STELARA** and **JNJ-77242113**, as well as placebo controls. **STELARA** is available in two formulations: a 90 mg solution for injection in a pre-filled syringe and a 45 mg solution for injection. The active substance in both formulations is **ustekinumab**, a protein-based therapeutic agent. The 90 mg formulation is administered subcutaneously using the UltraSafe Passive Delivery System, which is a needle guard system designed to meet ISO standards. The maximum daily dose for the 90 mg formulation is 90 mg, with a total maximum dose of 450 mg over a treatment period of up to 52 weeks. The 45 mg formulation is also administered subcutaneously, with a maximum daily dose of 45 mg and a total maximum dose of 225 mg over the same treatment period.

**JNJ-77242113** is an investigational drug provided in the form of a film-coated tablet. The active substance is also named **JNJ-77242113**, classified as a protein-based therapeutic agent. The administration route for this medication is oral. The trial evaluates the efficacy of JNJ-77242113 at dosages of 200 mg and 400 mg, although specific dosing schedules and maximum daily doses are not detailed in the provided data. The treatment period for JNJ-77242113 extends up to 100 weeks.

The study also includes placebo controls, specifically the **JNJ-77242113-AAC Placebo tablet** and solutions for injection in pre-filled syringes without **ustekinumab** (both 90 mg and 45 mg formulations). These placebo treatments are used to maintain the double-blind nature of the trial, ensuring unbiased assessment of the investigational drug's efficacy and safety. The placebo tablets and solutions do not contain active substances and are administered in a manner consistent with their respective active treatment counterparts.

The efficacy of the investigational product JNJ-77242113 in the treatment of active **Psoriatic Arthritis** (PsA) will be assessed in a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary endpoint for evaluating efficacy is the American College of Rheumatology (ACR) 20 response at Week 16. This endpoint measures a 20% improvement in tender and swollen joint counts, as well as a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain scale, disability/functional questionnaire, and an acute phase reactant (such as C-reactive protein). The trial aims to compare the efficacy of JNJ-77242113 at doses of 200 mg and 400 mg against a placebo in biologic-naïve participants with active PsA. Efficacy assessments will be conducted at Week 16 to determine the reduction in signs and symptoms of PsA. The trial will utilize validated scales and laboratory tests to collect and analyze the efficacy parameters, ensuring a rigorous evaluation of the treatment's impact on the disease.