Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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).

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus

Details

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.

Keywords

Systemic Lupus Erythematosus T regulatory cells (Tregs) Interleukin 2 Interleukin-2 Lupus Erythematosus, Systemic LY3471851 Mid Dose

Eligibility

You can join if…

Open to people ages 18-65

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California - San Diego not yet accepting patients
    La Jolla California 92037 United States
  • Desert Medical Advances accepting new patients
    Palm Desert California 92260 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE) (ISLAND-SLE)
ID
NCT04433585
Phase
Phase 2
Study Type
Interventional
Last Updated