Evaluation of Secukinumab for Maintenance of Remission in Non-Radiographic Axial Spondyloarthritis: A Randomized, Double-Blind, Placebo-Controlled Study

The primary objective of this study is to evaluate whether continuous treatment with **secukinumab** is superior to placebo in preventing flares during Treatment Period 2 in participants with non-radiographic axial spondyloarthritis who achieved a state of remission in Treatment Period 1. This is clinically relevant as it aims to determine the efficacy of secukinumab in maintaining remission and preventing disease exacerbation, which is crucial for improving long-term patient outcomes and quality of life.

Secondary objectives include:

• Evaluating the efficacy of secukinumab in preventing the onset of flares in participants who are in a state of remission during Treatment Period 2, having achieved remission in Treatment Period 1.
• Assessing the overall safety and tolerability of secukinumab over time up to the follow-up visit.

The clinical trial involves a total of **103 participants** diagnosed with **non-radiographic axial spondyloarthritis**. The study population includes both male and non-pregnant, non-lactating female participants who are at least 18 years of age. Participants were selected based on specific criteria, including a clinical diagnosis of axial spondyloarthritis according to the ASAS criteria, with inflammatory back pain for at least six months and onset before 45 years of age. The trial population exhibits objective signs of inflammation at screening, such as sacroiliitis on MRI or elevated hsCRP levels. Participants have active axial spondyloarthritis, as indicated by a BASDAI score of 4 cm or higher and significant spinal and total back pain. They have also been on at least two different NSAIDs at the highest recommended dose for a minimum of four weeks prior to baseline, with inadequate response or intolerance. The trial includes a vulnerable population, ensuring a comprehensive evaluation of the treatment's efficacy across diverse patient profiles.

The clinical trial is designed to evaluate the efficacy of **secukinumab** in maintaining remission in participants with non-radiographic axial spondyloarthritis. This is a multicenter, randomized, double-blind, placebo-controlled trial with a withdrawal-retreatment period. The trial aims to determine whether continuous treatment with secukinumab is superior to placebo in preventing flares during the second treatment period. The primary endpoint is the proportion of participants remaining flare-free at Week 120, while secondary endpoints include the time to flare during Treatment Period 2 and the safety and tolerability of the treatment, assessed through adverse events and changes in laboratory parameters and vital signs.

The trial is expected to last until June 2030, with an estimated recruitment start date in March 2023. Participants will be involved in the study for a maximum treatment period of 120 weeks. The study includes several key visits: an initial screening visit to confirm eligibility based on criteria such as age, clinical diagnosis, and objective signs of inflammation; baseline assessments; regular follow-up visits to monitor treatment response and safety; and an end-of-study visit to evaluate the overall outcomes. Participants are required to have a history of inadequate response to at least two different NSAIDs prior to baseline.

Inclusion criteria specify that participants must be male or non-pregnant, non-lactating females aged 18 years or older, with a clinical diagnosis of axial spondyloarthritis according to ASAS criteria. Exclusion criteria are not explicitly detailed in the provided data. Conditions that may lead to early termination from the study include significant adverse events or failure to adhere to the study protocol. The trial is categorized as a phase 4 study, indicating it is conducted after the drug has been approved for public use to gather additional information on its effectiveness and safety.

The clinical trial involves the administration of **Secukinumab**, a biologic agent classified as a **protein**. Secukinumab is provided in the form of a solution for injection, contained within a pre-filled syringe. The active substance, secukinumab, is administered via the **subcutaneous route**. The dosage regimen for secukinumab is set at a maximum daily dose of 150 mg, with a total maximum dose of 4950 mg over the course of the study. The treatment period extends up to 120 days. The pre-filled syringe device used for administration does not possess a CE mark, and the secondary packaging site differs from that of the authorized product.

The study also includes a **placebo** comparator, which is designed to match the secukinumab formulation. The placebo is a solution for injection in a pre-filled syringe, intended for subcutaneous use. The placebo serves as a control to evaluate the efficacy of secukinumab in maintaining remission in participants with non-radiographic axial spondyloarthritis. The administration schedule and dosing frequency for the placebo are identical to those of secukinumab, ensuring a double-blind study design. Compliance with the dosing regimen is monitored throughout the trial to ensure adherence to the protocol.

Efficacy in this clinical trial will be assessed by evaluating the maintenance of response in participants with non-radiographic axial spondyloarthritis who have achieved remission. The primary endpoint for efficacy is the proportion of participants remaining flare-free at Week 120. Secondary endpoints include the time to flare during Treatment Period 2. These endpoints will be measured at specified timepoints throughout the trial to determine the effectiveness of continuous **secukinumab** treatment compared to placebo in preventing flares. The assessment will involve the use of validated scales and patient-reported outcomes to ensure accurate and reliable data collection. The trial is designed as a multicenter, randomized, double-blind, placebo-controlled study, which will provide robust data on the efficacy of the treatment regimen.