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

NCT07393451 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SIM0278 injection

Placebo

Sponsors & Collaborators

  • Simcere Pharmaceutical Co., Ltd

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-03-31
Completion
2028-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07393451 on ClinicalTrials.gov