Evaluation of Long-term Safety and Tolerability of Dazodalibep in Patients with Sjögren’s Syndrome: A Multicenter, Randomized Extension Study

The primary objective of this study is to evaluate the long-term **safety** and **tolerability** of dazodalibep in participants with Sjögren’s Syndrome. This is clinically relevant as it aims to ensure that the therapeutic use of dazodalibep does not result in adverse effects over extended periods, which is crucial for chronic conditions like Sjögren’s Syndrome.

Secondary objectives include:

• To assess the **immunogenicity** of long-term administration of dazodalibep in participants with Sjögren’s Syndrome. This is important to determine if the immune system develops antibodies against the drug, which could affect its efficacy and safety.
• To characterize the **pharmacokinetics** (PK) of dazodalibep in participants with Sjögren’s Syndrome. Understanding the drug's absorption, distribution, metabolism, and excretion is essential for optimizing dosing regimens and ensuring effective treatment.

The clinical trial involves a total of **507 participants** diagnosed with **Sjögren’s Syndrome**. The study population includes both male and female subjects, with an age range that encompasses adults and older adults. Participants were selected based on their prior involvement in phase 3 studies of dazodalibep, specifically those who completed the study through Week 48. The trial does not specify particular lifestyle considerations such as diet or physical activity. The population includes vulnerable groups, indicating a diverse representation of individuals affected by the condition. The primary objective of the trial is to evaluate the long-term safety and tolerability of dazodalibep.

The clinical trial is designed as a **randomized**, double-blind, controlled study to evaluate the long-term safety and tolerability of **dazodalibep** in participants with **Sjögren’s Syndrome**. The trial is structured as a multicenter, long-term extension study, following participants who have completed a prior phase 3 study involving dazodalibep. The trial is expected to commence recruitment on May 6, 2025, and conclude by April 30, 2029, with a maximum treatment period of 144 weeks. Participants will receive dazodalibep as a **solution for infusion**, with a maximum daily dose of 53 mg and a total dose not exceeding 55,500 mg.

Study visits are sequenced to ensure comprehensive monitoring and data collection. The inclusion visit, or screening, will confirm eligibility based on prior participation in a phase 3 study and the ability to receive the first dose of the extension study. Follow-up visits will be scheduled to assess the incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and adverse events of special interest (AESIs). Secondary endpoints include the development of positive anti-drug antibodies (ADAs) and the plasma concentration of dazodalibep. The end-of-study visit will finalize data collection and assess the overall safety and tolerability of the treatment.

Participant involvement is expected to last up to 144 weeks, contingent upon adherence to study protocols and the absence of adverse events that may necessitate early termination. Conditions leading to early withdrawal include the development of significant adverse reactions or failure to comply with study requirements. The trial aims to provide valuable insights into the long-term effects of dazodalibep, contributing to the understanding of its safety profile in the treatment of **Sjögren’s Syndrome**.

The clinical trial involves the administration of **Dazodalibep**, an experimental medication, to evaluate its long-term safety and tolerability in participants with **Sjögren’s Syndrome**. **Dazodalibep** is a **solution for infusion** and is classified as a biological medicinal product. The active substance in **Dazodalibep** is a protein, specifically an anti-CD40 ligand-Tn3 fusion protein, which is also known by several synonyms including **VIB4920** and **MEDI4920**. The pharmaceutical form of **Dazodalibep** is a solution intended for infusion, and it is administered intravenously. The maximum daily dose is 53 mg, with a total maximum dose of 55,500 mg over a treatment period of up to 144 weeks.

In this study, **Dazodalibep** is the primary investigational product, and no additional non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are specified. The administration schedule and participant compliance are monitored to ensure adherence to the dosing regimen. The trial is designed to assess the safety profile of **Dazodalibep** over an extended period, providing valuable data on its tolerability in the target patient population.

Efficacy in this clinical trial will be assessed through the evaluation of several primary and secondary endpoints. The primary endpoint focuses on the incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and adverse events of special interest (AESIs). These parameters will be systematically collected and analyzed to determine the safety profile of **dazodalibep** in participants with Sjögren’s Syndrome.

Secondary endpoints include the development of positive anti-drug antibodies (ADAs) during the study and the plasma concentration of **dazodalibep**. These secondary measures will provide additional insights into the immunogenicity and pharmacokinetics of the drug. The collection and analysis of these endpoints will be conducted at specified intervals throughout the study duration, ensuring comprehensive monitoring of the drug's efficacy and safety profile.