NCT07185269

The Purpose of This Study is to Evaluate the Efficacy and Safety of 626 in the Treatment of SLE

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ib/II Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Immunogenicity of Anti-BDCA2 Antibody SSGJ-626 in Subjects With Systemic Lupus Erythematosus

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effect and safety of 626 in patients with SLE

Detailed description

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease with heterogeneous manifestations and disease course. Despite advances in medical care, there are still significant unmet needs in SLE with persistent disease activity, disease flares, intolerance to standard of care (SOC) therapies, and development of organ damage and co-morbidities. The purpose of this study is to demonstrate the clinical efficacy and safety of 626 added to standard of care (SoC) therapy compared to placebo with SoC therapy in subjects with SLE.

Conditions

• Systemic Lupus Erythematosus (SLE)

Interventions

Type	Name	Description
DRUG	626	626 subcutaneous (SC) injection. Placebo subcutaneous (SC) injection.
DRUG	626	626 subcutaneous (SC) injection.
DRUG	Placebo	Placebo subcutaneous (SC) injection.

Timeline

• Start date: 2025-09-24
• Primary completion: 2028-08-12
• Completion: 2028-11-04
• First posted: 2025-09-22
• Last updated: 2025-11-26

Locations

1 site across 1 country: China