The purpose of this study is to determine if investigational (not FDA approved) drug AMG570 can be an effective treatment for patients with Systemic lupus erythematosus (SLE) that are not responding well to their current standard of care therapy. This study will compare 3 dose levels with placebo (A placebo looks like the study drug, but the injection does not contain the active ingredient) to determine the ideal therapeutic dose. You will have 32 scheduled visits. Your participation in this study will last approximately 1 year and 5 months consisting of the following: Screening (2 visits); Treatment will be administered (by injection) every 2 weeks for 52 weeks; and safety follow-up (16 weeks).
To address the health disparities in SLE outcomes for minorities, targeted intervention will be used to address the common barriers to care among patients; a comprehensive patient navigator approach will be utilized based on evidence from prior studies is the purpose of this research. The navigator services most commonly provided include facilitation/coordination of care, practical support, including scheduling transportation and referrals to financial assistance programs, appointment scheduling and reminders, education and psycho-social support. The most effective patient navigators address both health system and patient barriers. Participation in the study will take 5 visits over a period of 12 months.
The purpose of this study is to see if a new medicine named BMS- 986165 will treat kidney inflammation caused by lupus (lupus nephritis). This study is a clinical trial—which is how new medicines are studied before they are approved by the FDA. This particular drug targets the JAK/STAT pathway to reduce autoimmunity and inflammation.
Lupus is an autoimmune disease, which means that your immune system not only attacks bacteria and viruses but also attacks your healthy cells and organs, affecting many parts of the body. Lupus can cause fever, joint pain, rash, sensitivity of the skin to sunlight, as well as other symptoms, and may lead to inflammation and organ damage.
Current treatments for lupus are mainly drugs that suppress the immune system such as cortisone-like drugs (for example prednisone) and cyclophosphamide (a potent drug sometimes used in treating certain types of cancer), and drugs commonly used to treat or prevent malaria (called antimalarials) such as hydroxychloroquine. Many of these treatments may have serious side effects if used for a long time.
Therefore, there is a need for new and effective treatments for lupus.