A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus
Overview
- Phase
- Phase 2
- Intervention
- LY3471851
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- Nektar Therapeutics
- Enrollment
- 291
- Locations
- 112
- Primary Endpoint
- Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
LY3471851 High Dose
LY3471851 administered subcutaneously (SC).
Intervention: LY3471851
LY3471851 Mid Dose
LY3471851 administered SC.
Intervention: LY3471851
LY3471851 Low Dose
LY3471851 administered SC
Intervention: LY3471851
Placebo
Placebo administered SC.
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24
Time Frame: 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).
Secondary Outcomes
- Percentage of Participants Who Achieved British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response at Week 24.(Week 24)
- Percentage of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) at Week 24(Week 24)
- Percentage of Participants Who Achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 24(Week 24)
- Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851(Week 24)