🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07393451
Starting soon Phase 2

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

NCT07393451 · tracked via the Priya Life Science China tracker
Sponsor
Simcere Pharmaceutical Co., Ltd
Phase
Phase 2
Started
2026-03-31
Last updated
2026-02-06

Condition(s) studied

Lupus Nephritis

Investigational drug(s) / intervention(s)

SIM0278 injection

SIM0278 injection: Placebo

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Weight ≥ 40.0 kg 2. SLE was diagnosed according to 2019 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) classification criteria. 3. Subjects must be receiving or willing to initiate induction therapy for LN. Induction therapy, defined as including high-dose glucocorticoids and MMF, should be initiated within 60 days or on the same day prior to baseline. Exclusion Criteria: 1. Previous or current nephropathy (except LN) that, in the opinion of the investigator, may interfere with the LN assessment and interfere with the assessment of disease activity (e.g., diabetic nephropathy). The subject was unable or unwilling to provide written informed consent and/or to comply with study procedures. 2. Severe renal impairment: a) oliguria (defined as recorded urine volume \< 400 mL/24 h), or b) end-stage renal disease (ESRD) requiring dialysis or transplantation. 3. Previous induction therapy for MMF/MPS was considered by the investigator to have failed.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking Union Medical College Hospital Beijing China

More Simcere Pharmaceutical Co., Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07393451 on ClinicalTrials.gov ↗ ← All trials in China