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).
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: LY3471851
- drug: Placebo
Eligibility
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
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.
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
infection.
Ages Eligible for Study
18 Years - 65 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
650-723-6961
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.