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RecruitingPhase 1Phase 2NCT07185269

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

Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Enrollment

198 participants

Start Date

Sep 24, 2025

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus (SLE)

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 626, a drug called 626, and others for people with systemic lupus erythematosus (sle). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG626

626 subcutaneous (SC) injection. Placebo subcutaneous (SC) injection.

DRUG626

626 subcutaneous (SC) injection.

DRUGPlacebo

Placebo subcutaneous (SC) injection.

Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT07185269

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