This study is looking at Sjögren’s Syndrome, a condition where the body’s immune system attacks its own moisture-producing glands, leading to dryness in the eyes and mouth, along with other symptoms throughout the body. The treatment being studied is Dazodalibep, which is also known by the code names HZN-4920, MEDI4920, and VIB4920. This medication is given as a solution for infusion, which means it is delivered directly into the bloodstream through a vein. The purpose of this study is to evaluate the long-term safety and how well people tolerate dazodalibep when used over an extended period.
This is an extension study, which means it is designed for people who have already participated in and completed earlier studies of dazodalibep for Sjögren’s Syndrome. Those who join this study will continue to receive dazodalibep treatment for a longer time so that researchers can observe how safe the medication is when used over many months or years. The study will track any unwanted effects that occur during treatment, including any serious health problems that might develop. Researchers will also check if the body develops any immune responses against the medication by looking for anti-drug antibodies, which are proteins the body might make in reaction to the treatment.
Throughout the study, blood samples will be collected to measure the amount of dazodalibep in the bloodstream, which helps researchers understand how the medication moves through and stays in the body. The study is open-label, meaning both the participants and doctors will know that everyone is receiving the active medication rather than placebo. This long-term study allows researchers to gather important information about the ongoing safety of dazodalibep in people with Sjögren’s Syndrome over an extended treatment period.
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