A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)

Not Recruiting

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).

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus

Stanford Investigator(s)

Yashaar Chaichian, MD
Yashaar Chaichian, MD

Clinical Associate Professor, Medicine - Immunology & Rheumatology


Inclusion Criteria:

   - 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.

Exclusion Criteria:

   - 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


drug: LY3471851

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305