Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease

Recruiting now · Phase 4

Conditions studied: Lupus or SLE, Interstitial Lung Disease, Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT07077486

Run by

Tongji Hospital

People needed

100

Starts

2025-08-25

Expected to finish

2027-03-25

Last updated by the study team

2026-01-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 weeks;
• Have a history of severe allergies;
• Patients with other serious lung diseases or other clinically significant serious abnormalities in the lungs;
• Are using antitumor drugs, other immunosuppressants or immunomodulatory therapies;
• Significant pulmonary hypertension;
• Previous clinical or echocardiographic evidence of significant right heart failure;
• Right heart catheterization showing cardiac index ≤ 2 L/min/m2;
• Pulmonary hypertension requiring treatment with epoprostenol/traprostacyclin.
• Patients with severe cardiovascular disease:
• myocardial infarction within 6 months;
• Unstable angina within 6 months.
• Risk of bleeding, any of the criteria listed below:
• known genetic predisposition to bleeding;
• Patients who require the following treatments:
• i. Fibrinolytic therapy, full-dose therapeutic anticoagulation (e.g., vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin); ii. High-dose antiplatelet therapy. [Note: Prophylactic low-dose heparin or heparin flush solution (e.g., enoxaparin, 4000 I.U. S.C. per day) required for maintenance of indwelling intravenous access devices is not prohibited.) and prophylactic antiplatelet therapy (e.g., acetylsalicylic acid up to 325 mg/day, or clopidogrel at a dose of 75 mg/day, or other antiplatelet therapy at the same dose).
• History of hemorrhagic central nervous system (CNS) events within 12 months;
• Any of the following conditions within a period of 3 months:
• hemoptysis or hematuria;

Where it is running

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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