Telitacicept versus cyclophosphamide for lupus-related interstitial lung disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with SLE and HRCT-confirmed interstitial lung disease will receive either telitacicept injections or standard-of-care cyclophosphamide with usual supportive medications and will be followed over time for lung outcomes and safety. Lung status will be monitored using high-resolution CT, pulmonary function tests (including DLCO), and clinical assessments. Blood and lung-related samples will be collected to explore immunologic mechanisms and potential biomarkers linked to diagnosis, prognosis, and treatment response. Safety labs and adverse event monitoring will be conducted throughout the treatment period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: YIKAI Dr. YU, M.D
• Email: yuyikai@163.com
• Phone: +86-15671678920

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.