Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus

To join this study, you need to be an adult between 18 and 70 years old and have been diagnosed with Systemic Lupus Erythematosus (lupus) for at least six months. Your lupus needs to be active, meaning you are currently experiencing symptoms or your test results show signs of inflammation.

You should also be taking certain medications for your lupus at a stable dose. This might include oral steroids (up to a certain dose), antimalarial treatments like hydroxychloroquine, or one specific type of stronger medication like azathioprine, mycophenolate, or methotrexate.

However, there are some reasons you might not be able to join. For example, if your lupus was caused by a medicine, or if you have severe kidney problems from lupus that would need different treatments. Other serious health conditions that could make it hard to assess your lupus, or severe problems affecting your brain and nervous system due to lupus, would also prevent you from taking part.

If you decide to take part, the study will last about 57 weeks in total. First, there's a screening period of up to 5 weeks to make sure the study is right for you. After that, you'll enter the main treatment period, which lasts 48 weeks. During this time, you'll be randomly assigned to receive either the study medicine, ESK-001, or a placebo (a dummy drug) – neither you nor your study doctor will know which you are receiving. You'll take this medicine regularly as instructed.

Throughout the 48 weeks, you'll have regular visits to the clinic for check-ups, blood tests, and to discuss any symptoms or side effects you might be experiencing. After the treatment period, there will be a 4-week follow-up period to monitor your health once you've stopped taking the study medication. If you complete the main study, there might be an opportunity to join an additional, longer-term study where everyone receives ESK-001.