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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
This study will evaluate the effect and safety of 626 in patients with SLE
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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Start Date
September 24, 2025
Primary Completion Date
August 12, 2028
Completion Date
November 4, 2028
Last Updated
November 26, 2025
198
ESTIMATED participants
626
DRUG
626
DRUG
Placebo
DRUG
Lead Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
NCT06647069
NCT06875960
Data Source & Attribution
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