We are studying a new drug called GS-5718 to see if it can help treat skin lupus (CLE). This drug is experimental, which means it has not been approved by the FDA for prescription use. If you join this study, you will be placed in one of the two groups at random, like flipping a coin. You have a 2 out 3 chance of getting the study drug and a 1 out 3 chance of getting a placebo. A placebo looks and is taken the same as the study drug but does not have any real medicine. You and the study team will not know what group you are in. One group will take two 15 mg tablets of the study drug every day. The other group will take two 15 mg placebo tablets every day. Both groups will take the tablets for 12 weeks. You will have to come in for 8 visits over about 16 weeks. The first visit will be to see if you qualify for the study. The other visits will check your health, and how well you are doing on the study drug. At the visits, you will talk about your health, lupus, and what medicines you take. You will get a physical exam and an ECG, which is a heart test. Your blood pressure, heart rate, breathing rate, and temperature will be checked. The study doctor will look at the areas of your skin affected by lupus and take photos. You will fill out surveys and give a blood sample. Your blood will be tested for routine health tests like TB and cholesterol tests, and to see how the study drug affects your body. It will also be tested to see how much of the study drug is in your body. You will have a skin biopsy, which means removing a small, round piece of skin for testing. The study lasts about 16 weeks. You can earn up to $800 if you complete all study visits.

Who can Participate

You can join this study if you are a male or a female who is not pregnant, between 18 and 75 years old, and have active skin lupus when you start the study. You must have tried at least one treatment before that did not work well or caused problems. These treatments include creams like steroid or calcineurin creams, pills like steroids, or other common lupus medicines such as chloroquine, quinacrine, hydoxychloroquine, azathioprine, mycophenolate mofetil, leflunomide, dapsone, or methotrexate. You BMI must be between 18 and 35. You must agree to use birth control during the study. You cannot join if you have other skin conditions like psoriasis. You also cannot join if you have used a drug called interleukin-1 receptor associated kinase 4(IRAK4) inhibitor or degrader, or if you have used cyclophosphamide or JAK inhibitor (like tofacitinib, baricitinib, upadacitinib) in the past 60 days. People who used oral prednisone at more than 10mg per day, injectable steroids, or two or more lupus medicines in the past 28 days cannot join. You also cannot join the study if you have used rituximab in the past 180 days.

Study ID