← Back to Clinical Trials
Recruiting Phase 4 NCT07077486

Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease

Trial Parameters

Condition Lupus or SLE
Sponsor Tongji Hospital
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2025-08-25
Completion 2026-10-25
Interventions
Methylprednisolone (Corticosteroid)Immunosuppressant other than CYCTelitacicept Freeze-dried powder Injection 80mg

Brief Summary

Recent data indicate that Telitacicept is beneficial for lupus nephritis. Our goal is to determine whether Telitacicept is an effective and safe treatment, compared to standard-of-care Cyclophosphamide, for subclinical and clinical ILD in patients with early lupus.

Eligibility Criteria

Inclusion Criteria: * Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus; * Male or non-pregnant female aged ≥ 18 years; * Diagnosis by high-resolution lung CT (HRCT) is clearly consistent with interstitial lung disease (ILD); * FEV1/FVC%≥60% and diffusion function DLCO (measured value/estimated value) ≥40%; * Patients voluntarily participate in this trial, have good compliance, and have the ability to understand and sign informed consent before the study. Exclusion Criteria: * Alanine aminotransferase and/or aspartate aminotransferase (ALT/AST) \> 5 times the upper limit of normal; * severe chronic kidney disease (stage IV) or need for dialysis (estimated glomerular filtration rate (eGFR) \< 30ml/min/1.73m2); * Hemoglobin \< 80 g/L; * WBC \< 2.0×10\^9; * Platelet \< 50×10\^9; * Is pregnant or breastfeeding; * Expected transfer to another hospital in a non-study site within 4 weeks (possibility of loss to follow-up); * Life expectancy does not exceed 24 we

Related Trials