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A Multicenter Phase 2a Clinical Study to Evaluate SIM0278 in Subjects With Active Lupus Nephritis
Sponsor: Simcere Pharmaceutical Co., Ltd
Summary
This is a randomized, double-blind, placebo-controlled multicenter clinical study to evaluate the efficacy, safety, and pharmacokinetics of SIM0278 in adult (18-75 years) subjects with active LN suitable for systemic therapy. Approximately 60 subjects with active LN are planned to be enrolled and randomized 1: 1 to SIM0278 or placebo. The study consists of 3 phases: screening, double-blind treatment, and safety follow-up.
Official title: A Randomized, Double-blind, Placebo, Parallel-Controlled, Multicenter Phase 2a Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of SIM0278 in Subjects With Active Lupus Nephritis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-03-31
Completion Date
2028-08-31
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
SIM0278 injection
Placebo
Locations (1)
Peking Union Medical College Hospital
Beijing, China