Open-Label Extension Study Evaluating Long-Term Safety and Tolerability of Subcutaneous Secukinumab in Patients with Polymyalgia Rheumatica

The primary objective of this multi-center, open-label extension study is to evaluate the **long-term safety** of subcutaneous **secukinumab** in patients with **polymyalgia rheumatica** (PMR). This will be assessed by monitoring the occurrence of adverse events and serious adverse events (AEs/SAEs). The clinical relevance of this objective lies in ensuring the sustained safety profile of secukinumab, which is crucial for its continued use in managing PMR, a condition characterized by muscle pain and stiffness. No secondary objectives are specified for this study.

The clinical trial involves a total of **167 participants** diagnosed with **Polymyalgia Rheumatica**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. Participants were selected based on their completion of a 52-week treatment period in a prior Novartis study of secukinumab, having experienced a relapse during the treatment-free follow-up period, and not having received rescue treatment. The trial includes a vulnerable population, indicating that special considerations are in place to ensure their safety and well-being. Lifestyle factors such as diet, physical activity, or habits are not specified in the available data. The selection criteria ensure that participants are those who would potentially benefit from secukinumab, with the benefit outweighing the risk as per the investigator's judgment.

The clinical trial is designed as a **multi-center, open-label extension study** to evaluate the long-term safety and tolerability of **secukinumab** in patients with **polymyalgia rheumatica**. The primary objective is to assess the occurrence of adverse events (AEs) and serious adverse events (SAEs) over the course of the study. Participants eligible for this trial are those who have completed a 52-week treatment period in a prior study of secukinumab and have experienced a relapse during the treatment-free follow-up period without having been on rescue treatment. The trial is expected to commence recruitment on September 13, 2024, and is estimated to conclude by May 8, 2028, with a maximum treatment period of 104 weeks.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on the specified criteria. Subsequent visits will be scheduled to monitor the safety and tolerability of the treatment, with assessments for any adverse events. The end-of-study visit will mark the conclusion of the participant's involvement, where final evaluations will be conducted. The expected length of participant involvement is up to 104 weeks, contingent upon the absence of any conditions that may necessitate early termination, such as the occurrence of significant adverse events or withdrawal of consent.

The trial will employ a subcutaneous route of administration for secukinumab, delivered in a solution for injection in a pre-filled syringe. The maximum daily dose is set at 300 mg, with a total maximum dose of 7800 mg over the treatment period. The study is categorized as a phase 3 trial, focusing on the long-term safety profile of the investigational product. Participants' continued involvement is subject to the investigator's judgment that the potential benefits of secukinumab outweigh any associated risks.

The clinical trial involves the administration of **secukinumab**, an experimental medication, to evaluate its long-term safety and tolerability in patients with polymyalgia rheumatica. Secukinumab is provided in the form of a **solution for injection in a pre-filled syringe**. The active substance, secukinumab, is a protein of other origin, specifically identified by the code AIN457. The medication is administered via the **subcutaneous route**. The maximum daily dose is 300 mg, with a total maximum dose of 7800 mg over the course of the study. The treatment period extends up to 104 weeks. The study employs a different secondary packaging site compared to the authorized product, although the primary formulation remains unchanged.

In this trial, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are utilized. The focus is solely on the administration of secukinumab to assess its safety profile. Participant compliance with the dosing schedule is monitored throughout the study to ensure adherence to the prescribed regimen. The trial is designed as a multi-center, open-label extension study, emphasizing the collection of data on adverse events and serious adverse events to determine the long-term safety of secukinumab in the target population.

The efficacy of the clinical trial involving **secukinumab** for the treatment of polymyalgia rheumatica (PMR) will be assessed primarily through the incidence of adverse events (AEs) and serious adverse events (SAEs). This open-label extension study aims to evaluate the long-term safety and tolerability of subcutaneous secukinumab. Participants eligible for this trial are those who have completed a 52-week treatment period in a prior Novartis study and have experienced a relapse during the treatment-free follow-up period without having been on rescue treatment. The trial is designed to monitor the occurrence of AEs and SAEs as the primary endpoint, providing insights into the long-term safety profile of secukinumab in this patient population. The study is planned to extend over a maximum treatment period of 104 weeks, with the estimated recruitment start date set for September 13, 2024, and an estimated end date of May 8, 2028.