NCT04433585

A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 291 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	LY3471851	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2020-08-19
• Primary completion: 2023-01-10
• Completion: 2023-02-16
• First posted: 2020-06-16
• Last updated: 2024-04-23
• Results posted: 2024-04-23

Locations

112 sites across 19 countries: United States, Argentina, Australia, Canada, Czechia, Germany, Hungary, India, Israel, Japan, Mexico, Poland, Puerto Rico, Romania, Russia, South Korea, Spain, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study