NCT06675422

JY231 Injection for the Treatment of Active Systemic Lupus Erythematosus (SLE)

JY231 Injection for the Treatment of Active Systemic Lupus Erythematosus (SLE) - A Safety, Tolerability, and Efficacy Study

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of active systemic lupus erythematosus (SLE)

Detailed description

This is a single-center, single-arm. open-label clinical study, in this study. approximately 10-20 patients with active systemic lupus erythematosus (SLE) will be enrolled for JY231 infusion therapy. The safety of JY231 was evaluated by observing adverse events after therapy. Evaluate the effectiveness of JY231 treatment.

Conditions

• Systemic Lupus Erythematosus (SLE)

Interventions

Type	Name	Description
DRUG	JY231 injection	Dose escalation was carried out using the 3+3 principle and the mode of administration was intravenous.

Timeline

• Start date: 2024-10-09
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2024-11-05
• Last updated: 2024-11-05

Locations

1 site across 1 country: China