A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

To join this study, you need to be an adult between 18 and 70 years old and have had a diagnosis of lupus for at least 24 weeks. Your lupus also needs to be active enough to warrant a new treatment at the start of the study, as judged by your doctors using specific medical scores. You must already be receiving at least one standard lupus treatment, such as steroids, antimalarial drugs, or other immune-suppressing medicines.

There are also some reasons why you might not be able to join. For instance, if you have severe kidney lupus that isn't stable, or if you've had a recent blood clot. Also, if you have another significant inflammatory condition that could make it difficult to properly assess your lupus symptoms, or active severe brain or nerve-related lupus, you might not be eligible.

If you decide to take part, you'll first have a screening period lasting up to 28 days to confirm you're suitable for the study. Then, you'll enter the main treatment phase, which lasts for 24 weeks. During this time, you'll receive either Obexelimab or a dummy medicine as an injection under your skin once a week. These injections will be given at the study site or you'll be shown how to give them yourself.

You'll need to attend regular appointments at the study site: at week 2, week 4, and then every 4 weeks until the end of the 24-week treatment period. After that, there's a 12-week follow-up period with further visits to check on your health and any long-term effects. Throughout the study, doctors will carry out various checks to see how well the treatment is working and to monitor your safety. Your total time in the study, including all screening and follow-up, will be around 40 weeks.