Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus

To join this study, you must have previously completed a full 12 months in one of the earlier cenerimod studies (either ID-064A301 or ID-064A302) and still have a diagnosis of systemic lupus erythematosus. You must also have followed the rules of that previous study well and completed all your visits.

There are also some reasons why you might not be able to join. For example, if your kidney lupus is very severe or your lupus is significantly affecting your brain, and your doctor thinks you need different or stronger treatments than those allowed in the study, you may not be eligible. Also, if you are a woman who could get pregnant, you must agree to take monthly pregnancy tests and use very effective contraception throughout the study and for six months after your last dose of medication. If you are planning to become pregnant during this time, you cannot join.

The study is open to adults between 18 and 75 years old, and anyone of any gender can participate. Your study doctor will review all the criteria carefully to ensure this study is right for you.

If you join this study, you will receive cenerimod 4 mg once a day, in addition to your usual lupus medications (which might include steroids, anti-malarial drugs, or immunosuppressants). All participants in this study will receive the active medication, cenerimod; there won't be a dummy pill (placebo) in this part of the study.

You will take cenerimod for at least one year and potentially up to three years. Your total time in the study, including follow-up, could be up to three and a half years. During this period, you will have regular visits to the clinic so the research team can monitor your health, check for any side effects, and see how your lupus symptoms are responding. After your last dose of cenerimod, there will be a follow-up period of six months with a final study visit to ensure everything is well.