A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)
Purpose
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).
Condition
- Systemic Lupus Erythematosus
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental LY3471851 High Dose |
LY3471851 administered subcutaneously (SC). |
|
Experimental LY3471851 Mid Dose |
LY3471851 administered SC. |
|
Experimental LY3471851 Low Dose |
LY3471851 administered SC |
|
Placebo Comparator Placebo |
Placebo administered SC. |
|
More Details
- Status
- Completed
- Sponsor
- Nektar Therapeutics
Study Contact
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 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.