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

NCT07393451 | Not Yet Recruiting Phase 2

• 1 other identifier: SIM0278-202
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving an overall renal response (complete renal response (CRR) + partial renal response (PRR)) at Week 52

  At Week 52

Study Arms (2)

Test group

EXPERIMENTAL

Cohort 1- Test group

Drug: SIM0278 injection

Control group

EXPERIMENTAL

Cohort 2- Control group

Drug: SIM0278 injection

Interventions

SIM0278 injection DRUG

Placebo

Control group; Test group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight ≥ 40.0 kg
• SLE was diagnosed according to 2019 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) classification criteria.
• 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.

You may not qualify if:

• 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.
• 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.
• Previous induction therapy for MMF/MPS was considered by the investigator to have failed.

Sponsors & Collaborators

• Simcere Pharmaceutical Co., Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)