Long-term Safety Evaluation of Secukinumab in Patients with Psoriatic Arthritis, Ankylosing Spondylitis, Axial Spondyloarthritis, and Chronic Plaque Psoriasis

The primary objective of this study is to evaluate the long-term **safety** of **Secukinumab** in patients who have completed a previous Novartis-sponsored Secukinumab study. This is assessed by monitoring the occurrence of adverse events (AEs) and serious adverse events (SAEs). The clinical relevance of this objective lies in ensuring the continued safety of Secukinumab for patients with conditions such as Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, Severe Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis, and Juvenile Idiopathic Arthritis. The study does not list any secondary objectives.

The clinical trial involves a total of **500 participants** diagnosed with conditions such as **Psoriatic Arthritis**, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, Severe Chronic Plaque Psoriasis, Moderate to severe Chronic Plaque Psoriasis, and Juvenile idiopathic Arthritis. The study population includes both male and female subjects, with age categories ranging from children to adults. Participants were selected based on their previous involvement in a Novartis study of secukinumab, with the requirement that they are deriving benefit from the treatment and are unable to access the marketed formulation due to local prescription or reimbursement guidelines. The trial includes a vulnerable population, indicating special considerations for ethical and safety measures. Lifestyle factors such as diet and physical activity are not specified, and the general health status of participants is not detailed beyond their specific medical conditions.

The clinical trial is designed to evaluate the long-term safety of **secukinumab** in patients with conditions such as **psoriatic arthritis**, **ankylosing spondylitis**, non-radiographic axial spondyloarthritis, severe chronic plaque psoriasis, moderate to severe chronic plaque psoriasis, and juvenile idiopathic arthritis. This is an open-label, multi-center study involving patients who have completed a previous Novartis-sponsored secukinumab study and are deemed by the investigator to benefit from continued treatment. The trial is categorized as a Phase 4 study, focusing on the assessment of adverse events (AEs), serious adverse events (SAEs), and injection site reactions as primary endpoints.

The trial employs a non-randomized, open-label design, allowing for the continuous administration of secukinumab via subcutaneous injection. The maximum treatment period is 104 weeks, with a maximum daily dose of 300 mg and a total dose not exceeding 8100 mg. Participants are expected to be involved in the study for the entire duration unless early termination is warranted due to safety concerns, lack of efficacy, or other technical or administrative reasons. The study commenced on December 22, 2020, and is estimated to conclude by January 5, 2027.

Study visits are structured to include an initial screening visit to confirm eligibility based on the inclusion criteria, which require signed informed consent, effective communication with the investigator, and prior completion of a Novartis secukinumab study. Follow-up visits are scheduled to monitor the safety and efficacy of the treatment, with assessments for AEs and SAEs. The end-of-study visit will finalize the participant's involvement, ensuring all safety and efficacy data are collected. Participants may be withdrawn from the study if they no longer derive benefit from the treatment or if they gain access to the marketed formulation of secukinumab per local guidelines.

The clinical trial involves the administration of **Secukinumab**, an experimental medication, which is provided in two pharmaceutical forms. The first form is a **solution for injection in a pre-filled syringe**. This formulation is intended for subcutaneous administration. The maximum daily dose is 300 mg, with a total maximum dose of 8100 mg over a treatment period of up to 104 weeks. The pre-filled syringe is not a pediatric formulation and is used in adult participants. The secondary packaging site for this product differs from the authorized product, which is a notable change in the trial.

The second form of **Secukinumab** is also a **solution for injection**, but it is specifically formulated for pediatric use. This formulation is similarly administered subcutaneously, with the same dosing regimen as the adult formulation: a maximum daily dose of 300 mg and a total maximum dose of 8100 mg over 104 weeks. This pediatric formulation includes a device component, although it does not possess a CE mark. The secondary packaging site for this product also differs from the authorized product.

In this clinical trial, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are utilized. The focus is solely on the long-term safety of **Secukinumab** as assessed by the occurrence of adverse events (AEs) and serious adverse events (SAEs). Participant compliance with the dosing schedule is monitored throughout the study to ensure adherence to the prescribed regimen.

The efficacy of the clinical trial involving **Secukinumab** will be assessed primarily through the evaluation of serious adverse events (SAEs), adverse events (AEs), and injection site reactions. These parameters will serve as the primary endpoints for determining the long-term safety and efficacy of the treatment. The trial is designed as an open-label, multi-center study for patients who have completed a previous Novartis-sponsored Secukinumab study and are deemed by the investigator to benefit from continued treatment with Secukinumab.