Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease
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.
| Condition(s) | Lupus or SLE, Interstitial Lung Disease, Systemic Lupus Erythematosus |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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. |
| Who can participate | 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; * Plat |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Tongji Hospital |
| Locations | Wuhan, Hubei, China |
| Start date | 2025-08-25 |
| NCT ID | NCT07077486 |
| Official listing | https://clinicaltrials.gov/study/NCT07077486 |