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NOT YET RECRUITING
NCT07393451
PHASE2

A Multicenter Phase 2a Clinical Study to Evaluate SIM0278 in Subjects With Active Lupus Nephritis

Sponsor: Simcere Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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

DRUG

SIM0278 injection

Placebo

Locations (1)

Peking Union Medical College Hospital

Beijing, China