©2022 Stanford Medicine
A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)
Trial ID: NCT04433585
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).
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus
- 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
- 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
School of Medicine
300 Pasteur Drive
Stanford, CA 94305