This study will test if adding a new medicine called VIB4920 to regular lupus treatment can help people with lupus nephritis (a kidney problem caused by lupus) feel better. It will also check if this new medicine is safe.
Lupus nephritis is a kidney problem caused by lupus. This study is trying to find out if a new medicine, VIB4920, can help. Everyone in the study will take their usual lupus medicines. Some people will also get VIB4920, and others will get a placebo (a pill that looks the same but has no medicine in it). The study will last up to 60 weeks, which is a little more than 14 months. Around 74 people from all over the U.S. will join. During the study, you will have regular checkups, blood and urine tests, and possibly kidney biopsies. Some of your samples will be saved for research, including tests on your DNA. These tests won’t look at all your DNA and won’t be used to diagnose anything. You won’t get results from these tests, and they won’t be shared with your doctor or added to your medical record. If you leave the study early or your treatment changes, you may have up to 6 extra visits. One of these is a full checkup with lab tests. The others are check-ins at weeks 12, 24, 36, 48, and 60 (if you haven’t already had them). You might also be asked to come in for extra visits if you’re not feeling well or if your doctor wants to check your health. These visits help keep you safe and make sure the study gets good information. The study will pay for all the medicines, tests, and procedures needed for this study.
You may be able to join if you are 18 or older and have been told you have systemic lupus erythematosus (SLE). Your kidneys must be affected by lupus, and your urine protein-to-creatinine ratio (UPCR) must be 1.0 or higher, based on a 24-hour urine test. You also need to have had a kidney biopsy in the past 24 weeks. The biopsy must show certain types of kidney damage caused by lupus: Class III, Class IV, or Class V lupus nephritis. Class V is only allowed if it’s also with Class III or IV. The biopsy must also show a certain level of disease activity, called a Modified NIH Activity Index of 1 or more.
Protocol Number: 22-0596
More information available at ClinicalTrials.gov: NCT05201469
Principal Investigator