The purpose of this study is to see if a new drug called CC-220 can be safe and effective to treat patients with Systemic Lupus Erythematosus. CC-220 is an oral medication. The study will last for about one year and will involve 16 study visits. There are two parts to the trial: In the first, patients will be assigned to get either CC-220 at 0.45mg, 0.3mg, 0.15 mg, or placebo (no active study drug). In the second part, all patients who got placebo during the first part will be re-assigned to get CC-220 at either 0.45mg or 0.3mg. The study will be blinded, which means you will not know which medication you are getting during either of the two parts. You will see a Rheumatologist, and give a blood and urine sample at each visit. The data obtained from this study will provide additional information to further assess the benefit and risk profile of CC-220 for the treatment of lupus.
Often considered as related diseases, systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) are severe autoimmune disorders characterized, among other, by dysregulation of immune cells in the blood. The roles of different immune cells in SLE and SSc remain unclear. It is of increasing importance to characterize specific immune cells and define their impact on autoimmune disease, which may lead to new therapies. The goal of this study is to identify blood immune cells associated with SLE and SSc.
The primary objective of the study is to assess whether Orelvo, added to the standard of care treatment for patients with Lupus Nephritis, is able to reduce disease activity. The study will last for about 1 years and will involve 16 study visits. Patients who meet criteria will be assigned to one of two groups: One group will receive Orelvo 23.7mg taken twice a day by mouth, and the other will receive placebo. The study is blinded, with means neither the patient nor the study doctor will know what group subjects are in. Patients will be followed closely by the study doctors to determine their lupus activity levels over the course of 1 year.
We have already observed that the blood cells known as monocytes from patients with the fibrotic disease scleroderma behave differently from monocytes from healthy controls. Here we will test whether patients with other fibrotic diseases also have altered monocyte function. Specifically, we will get blood from congestive heart failure and lupus patients and compare their monocytes to scleroderma patient and healthy subject monocytes. Our recent results in a mouse model for congestive heart failure suggest that we will find altered monocyte behavior in human congestive heart failure patients.
The purpose of this study is to see if filgotinib and/or GS-9876 can be safe and helpful to treat patients with Lupus Membranous Nephropathy. These are both oral medications. The study will last for about one year and will involve 18 study visits. Patients will be assigned to get either filgotinib or GS-9876 at the beginning of the study. At Week 16, they will be evaluated to see if their LMN is improving. If so, they will remain on whichever drug they received. If not, they will switch to the other drug. At Week 32, patients will once again be evaluated. Based on those results, patients may remain on the same drug, or switch to the other group. This process will be blinded so that even though you will always be getting active drug, you will not know which one.
The purpose of the study is to characterize the inflammatory response in lupus nephritis kidneys in order to identify the cellular and molecular pathways of injury. It will involve patients who are already scheduled to have a kidney biopsy to clarify the diagnosis of lupus nephritis and/or to guide therapy. During the biopsy, doctors will take an extra "core" of kidney tissue for research purposes in addition to the one used for clinical reasons. If you enroll in the trial, you will have 7 visits, including your kidney biopsy. The first two visits occur within 2 weeks, then follow up visits after 3, 6, 12, 18 and 24 months.
This double-blinded placebo-controlled research study is being done to test the effectiveness, safety, and tolerability of the experimental drug JBT-101 in patients with systemic lupus erythematosus (SLE). We will see if JBT-101 taken by mouth stops inflammation and how well JBT-101 is tolerated. The study will evaluate whether JBT-101 will decrease the pain associated with active arthritis or tendonitis in SLE subjects. JBT-101 is manufactured entirely from chemicals and its structure is similar to the end product of a chemical in marijuana. This drug was designed to have the known anti-inflammatory properties of marijuana without the effects on brain function and mood.
The primary objective of the trial is to assess the ability of hydroxychloroquine to prevent the development of SLE in persons at risk for the disease. Subjects will be assigned to one of two groups: one with receive oral hydroxychloroquine, and one will receive oral placebo. The study lasts for about two years, with visits being once every 3 months, for a total of 12 visits. Two of those visits will be with an ophthalmologist to monitor eye health. At each visit, the study team will monitor your symptoms and health.
Part A of the study is for people who have Systemic Lupus Erythematosus (SLE) and have active skin disease. This study will look at how well different doses of the study drug BIIB059 works in reducing active skin disease and other lupus manifestations in patients with SLE during 24 weeks of treatment. This study will also look at how well patients tolerate the doses of study drug being tested in this study and what happens to the study drug in the body; for example, how long it remains in your blood and how quickly it is removed from your body.
Part B of the study is for people who have active cutaneous lupus erythematosus (CLE) with or without signs of systemic LE. This study will look at how well the study drug BIIB059 works in reducing skin disease in patients with CLE after 4 to 12 weeks of treatment. This study will also look at how well patients tolerate the study drug and what happens to the study drug in the body; for example, how long it remains in your blood and how quickly it is removed from your body.
The purpose of this study is to evaluate the safety of mesenchymal stem cells (MSCs) obtained from an umbilical cord for the treatment of adults with systemic lupus erythematosus (SLE). The primary goal is to determine if a single MSC infusion is safe and well-tolerated for patients with mild to moderately active SLE.