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A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
Sponsor: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
Summary
The purpose of this study is to evaluate the efficacy and safety of IMC-002 and IMM0306S in the treatment of active SLE.
Official title: A Multi-center, Randomized, Double-blind, Placebo Control Phase 1b/II Study to Evaluate the Safety and Efficacy of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
218
Start Date
2024-10-10
Completion Date
2028-12-17
Last Updated
2026-06-29
Healthy Volunteers
No
Conditions
Interventions
IMC-002 + SOC
intravenous injection of 0.8mg/kg、1.2mg/kg and1.6mg/kg
Placebo + SOC
intravenous or subcutaneous injection of Placebo
IMM0306S + SOC
subcutaneous injection of 2.0 mg/kg,4.0 mg/kg and 6.0mg/kg
Locations (1)
Peking University People's Hospital
Beijing, China