Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease

Launched by TONGJI HOSPITAL · Jul 21, 2025

Keywords

ClinConnect Summary

This study is checking whether Telitacicept, given as a weekly injection, works safely and better than the standard therapy Cyclophosphamide for people who have lupus (systemic lupus erythematosus, SLE) and a type of lung problem called interstitial lung disease (ILD). It is a phase 4 trial with two treatment groups and about 100 adult participants. To join, you would need to be 18–80 years old, meet the lupus criteria used by doctors, have ILD confirmed by a lung scan, and have lung test results showing fairly usable lung function. The study is being run at Tongji Hospital in Wuhan, China, and will include safety checks and follow-up for about a year.

Participants are assigned to either Telitacept plus usual care (like steroids or other immune medicines, but not Cyclophosphamide) or to the usual care with Cyclophosphamide (and other allowed medicines). Telitacept is a drug that aims to calm the immune system by targeting specific proteins involved in B cells. The study will measure several outcomes over 52 weeks, including how lung function changes (a measure called FVC), how well the lungs exchange gases (DLco), antibody levels, blood protein levels, walking distance in 6 minutes, and the total steroid dose used. It will also look at a lung disease biomarker called KL-6. This study has safety oversight, and results are not yet available.

Gender

ALL

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 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;
• • 1. Right heart catheterization showing cardiac index ≤ 2 L/min/m2;
• • 2. Pulmonary hypertension requiring treatment with epoprostenol/traprostacyclin.
• * Patients with severe cardiovascular disease:
• • 1. myocardial infarction within 6 months;
• • 2. Unstable angina within 6 months.
• * Risk of bleeding, any of the criteria listed below:
• • 1. known genetic predisposition to bleeding;
• 2. 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:
• • 1. hemoptysis or hematuria;
• • 2. Active gastrointestinal bleeding or gastrointestinal ulcers;
• • Have previously undergone hematopoietic stem cell transplantation (HSCT), or plan to receive HSCT in the following year, or plan to undergo major surgery.
• • Women who are pregnant, breastfeeding or planning to become pregnant during the test;
• • 28 days before administration or 3 months after administration, women of childbearing age are unwilling or unable to use highly effective contraceptive methods;
• • According to the investigator's point of view, the patient has alcohol or drug abuse;
• • History of dysphagia or any gastrointestinal disease that affects drug
• • Patients with contraindications to the use of tatacept;
• • Subjects deemed unsuitable for participation in the study by the investigator.