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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
291
Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24
Percentage of Participants who Achieved a ≥4 Point Reduction in SLEDAI-2K Score at Week 24. A SLEDAI-4 response is defined as a ≥4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score from baseline. The SLEDAI-2K score range is from a minimum of 0 to a maximum of 105 (higher scores represent higher disease activity).
Time frame: Week 24
Percentage of Participants Who Achieved British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response at Week 24.
Percentage of Participants who Achieve BICLA Response at Week 24. The BILAG-based Composite Lupus Assessment (BICLA) is a composite index used to assess disease activity in SLE. A BICLA response is defined as: * Reduction of all baseline BILAG-2004 A to B or C or D; and baseline BILAG-2004 B to C or D; and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B. * No worsening from baseline in SLEDAI-2K, where worsening is defined as any increase from baseline in SLEDAI-2K. * No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point PGA visual analogue scale (VAS).
Time frame: Week 24
Percentage of Participants Who Achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 24
Percentage of Participants who Achieved a SRI-4 Response at Week 24. A SRI-4 response is defined as a decrease in SLEDAI-2K \>= 4 from baseline. No new BILAG A and no more than 1 new BILAG B disease activity score / organ domain (both compared with baseline), and no worsening in PGA (defined as an increase of 0.3 points \[10 mm\] from baseline.
Time frame: Week 24
Percentage of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) at Week 24
Percentage of Participants who Achieved LLDAS at Week 24. A LLDAS response is defined as a low level of disease activity attained without use of low-dose steroids and/or standard-of-care immunosuppressant medications.
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University of California - San Diego
La Jolla, California, United States
Desert Medical Advances
Palm Desert, California, United States
Stanford University Hospital
Stanford, California, United States
Inland Rheumatology & Osteoporosis Medical Group
Upland, California, United States
University of Colorado School of Medicine
Aurora, Colorado, United States
Clinical Research Center of CT/NY
Danbury, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
University of Miami School of Medicine
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
...and 102 more locations
Time frame: Week 24
Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851
LY3471851 plasma trough concentrations are the concentrations of drug in plasma immediately before the next dose is administered.
Time frame: Week 24