NCT05680480

A Study of Telitacicept in Lupus Nephritis

A Phase Ⅱ, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Telitacicept in Lupus Nephritis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with active lupus nephritis.

Detailed description

This is a phase 2, multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of telitacicept versus placebo while taking standard of care (SOC) treatment in adult subjects with active proliferative lupus nephritis (LN).

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
BIOLOGICAL	Telitacicept 240 mg	Participants will receive Telitacicept 240mg weekly in addition to SOC for 48 weeks.
BIOLOGICAL	Telitacicept 160 mg	Participants will receive Telitacicept 160mg weekly in addition to SOC for 48 weeks.
DRUG	Placebo	Participants will receive placebo weekly in addition to SOC for 48 weeks.

Timeline

• Start date: 2023-04-17
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2023-01-11
• Last updated: 2024-09-23

Locations

45 sites across 1 country: China