NCT07299422

A Study of SHR-2173 in Participants With Systemic Lupus Erythematosus

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2173 Injection in Patients With Systemic Lupus Erythematosus

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blind, multi-center, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in adult participants with active Systemic Lupus Erythematosus (SLE), including a 4-week screening period, a 24-week core treatment period, a 24-week maintenance treatment period, and a 12-week safety follow-up period. Approximately 245 SLE patients will be included.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	SHR-2173 Injection	SHR-2173 injection in different doses.
DRUG	SHR-2173 Injection Placebo	SHR-2173 injection placebo.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2028-11-01
• First posted: 2025-12-23
• Last updated: 2026-03-20

Locations

2 sites across 1 country: China