NCT03556007

A Study of NKTR-358 (LY3471851) in Participants With Systemic Lupus Erythematosus (SLE)

A Phase 1, Double-blind, Randomized, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous NKTR-358 in Patients With Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the safety and tolerability of a study drug known as LY3471851 in participants with SLE. The study will last about 79 days for each participant.

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. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and immunologic effects of multiple doses of LY3471851 in participants with minimal to moderate SLE. The effects on SLE disease activity will also be evaluated. SLE participants will be randomized to receive multiple subcutaneous (SC) doses of LY3471851 or receive placebo. After receiving the last dose of LY3471851 or placebo, participants will be followed for an additional 50 days to evaluate safety, PK, pharmacodynamics (PD), and preliminary efficacy.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	LY3471851	LY3471851 drug product is a sterile liquid for subcutaneous injection that will be diluted with sterile 0.9% sodium chloride solution for injection (USP) prior to administration.
DRUG	Placebo	The placebo dosing solution is 0.9% sodium chloride for injection (USP).

Timeline

• Start date: 2018-04-18
• Primary completion: 2019-08-29
• Completion: 2019-08-29
• First posted: 2018-06-14
• Last updated: 2023-11-18

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study