Status:
COMPLETED
A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
Nektar Therapeutics
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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).
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2023
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT04433585
Start Date
August 19 2020
End Date
February 16 2023
Last Update
April 23 2024
Active Locations (112)
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1
University of California - San Diego
La Jolla, California, United States, 92037
2
Desert Medical Advances
Palm Desert, California, United States, 92260
3
Stanford University Hospital
Stanford, California, United States, 94305
4
Inland Rheumatology & Osteoporosis Medical Group
Upland, California, United States, 91786