drugset / Trial / NCT07381465

Efficacy and Safety of IL-1 Inhibitors in Mild to Moderate Systemic Lupus Erythematosus

NCT07381465

Phase 4 Active not recruiting 15 enrolled Chinese SLE Treatment And Research Group
NaSingle-groupOpen-labelTreatment

Summary

Systemic lupus erythematosus (SLE) is a systemic autoimmune disorder in which pro-inflammatory factors of the IL-1 family play a pivotal role in its pathogenesis. In SLE patients, an innate immune hyperreactivity coupled with excessive inflammasome activation leads to substantial IL-1β production, triggering inflammatory phenotypes such as fever and serositis. For SLE patients unresponsive to conventional therapies, particularly those exhibiting high fever and serositis indicative of innate immune overactivation, effective targeted treatments remain scarce. Firsekibart, as a first anti-IL-1β biologic, holds promise in delivering novel therapeutic benefits for SLE patients with high-inflammatory phenotypes who prove refractory to standard therapies.

Timeline

Start
2026-06-16
Primary completion
2027-12-20
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Firsekibart Protein / enzyme biologic 200 mg Subcutaneous