NCT05899907

Efficacy and Safety of Telitacicept in Early SLE

A Study of Telitacicept in the Treatment of Early Stage Systemic Lupus Erythematosus

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with early stage of SLE .

Detailed description

This is a phase 4, multicentre, randomised, double-blind, open-labeled study to evaluate the efficacy and safety of telitacicept in adult subjects with active early stage of SLE (disease duration less than 2 years).

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DRUG	Telitacicept	160mg once a week for 48 weeks
DRUG	Standard of Care	Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-03-01
• Completion: 2025-09-01
• First posted: 2023-06-12
• Last updated: 2023-06-12

Locations

20 sites across 1 country: China