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

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

More Details

Status
Active, not recruiting
Sponsor
Eli Lilly and Company

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.