A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)
The reason for this study is to see if the study drug LY3471851 (NKTR-358) is safe and effective in adults with systemic lupus erythematosus (SLE).
- Systemic Lupus Erythematosus
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Have a clinical diagnosis of SLE at least 24 weeks prior to screening. - Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization. - Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening. - Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 during screening. - Have a clinical SLEDAI-2K score ≥4 at randomization. - Have active arthritis and/or active rash.
- Have severe active lupus nephritis. - Have active central nervous system (CNS) lupus. - Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data. - Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Double (Participant, Investigator)
LY3471851 High Dose
|LY3471851 administered subcutaneously (SC).||
LY3471851 Mid Dose
|LY3471851 administered SC.||
LY3471851 Low Dose
|LY3471851 administered SC||
|Placebo administered SC.||
- Eli Lilly and Company
Study ContactThere may be multiples sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
LY3471851 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune system back into balance.