If you join the study, in the first part, you'll be put into one of two groups. You won't know which group you're in, and the study team won't know either. One group will take a pill every day with 30 mg of a study drug called Upadacitinib. The other group will take a placebo pill. It looks the same but doesn't have any medicine in it. Upadacitnib is approved by the FDA to treat other diseases like rheumatoid arthritis and psoriatic arthritis, but it's not approved for lupus yet. This means using it to treat lupus is experimental. Both pills are taken by mouth. During the study, we will ask you for some personal information and look at your medical history. At the study visits, you'll get a physical exam, and have your temperature, blood pressure, pulse, and breathing checked. You'll get a heart test called an ECG. It shows your heart rate and rhythm. You'll give blood and urine samples at different visits so we can check your health. You will fill out surveys to tell us how you're feeling. In the first part of the study, you'll come in for 16 visits over 58 weeks. After the first part of the study, you might be asked to join a second part of the study if the study doctor thinks it will help your lupus. In the second part of the study, you'll be placed into one of two groups. One group will take a 30 mg pill of Upadacitinib every day and the other group will take a 15 mg pill of Upadacitinib every day. You'll come in for 6 visits over 52 weeks. At the study visits, you will do many of the same things you did in the first part of the study. You can choose to join just the first part of the study without doing the second part. You can get $75 for each visit that you complete. This is a total of $1,200 for the first part of the study and $450 for the second part of the study.

Who can Participate

You might be able to join this study if you are between 18-63 years old, you were diagnosed with lupus (SLE) at least 24 weeks ago, and you have been on the same lupus treatment for more than 60 days. You cannot join this study if you have serious kidney problems (called class III or IV Lupus Nephritis) that were treated in the last 6 months. If you have other autoimmune diseases, you can't join the study. People with active brain or mental health problems caused by lupus (excluding lupus headache) cannot take part. If you have a blood clotting disorder called antiphospholipid syndrome and are not on the proper blood thinners you can't be in the study. You have had two or more cases of shingles, or a serious case that spread to your eyes, you can't join the study. People that have had cancer before (except for some skin or cervical cancers that were successfully treated) can't take part in the study. You cannot be pregnant, breastfeeding, or planning on becoming pregnant during the study. If you have a surgery planned during the study, you can't join the study. The study doctor will evaluate other criteria during your first visit to make sure that it is safe for you to join the study.

Study ID

More information available at ClinicalTrials.gov: NCT05843643