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

ArmDescriptionAssigned Intervention
Experimental
LY3471851 High Dose
LY3471851 administered subcutaneously (SC).
  • Drug: LY3471851
    Administered SC
    Other names:
    • NKTR-358
Experimental
LY3471851 Mid Dose
LY3471851 administered SC.
  • Drug: LY3471851
    Administered SC
    Other names:
    • NKTR-358
Experimental
LY3471851 Low Dose
LY3471851 administered SC
  • Drug: LY3471851
    Administered SC
    Other names:
    • NKTR-358
Placebo Comparator
Placebo
Placebo administered SC.
  • Drug: Placebo
    Administered SC

Recruiting Locations

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
216-778-5154

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiples sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
clinicaltrials.gov@lilly.com

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.