Telitacicept versus cyclophosphamide for lupus-related interstitial lung disease

A Randomized, Positvel Controlled, Multicenter Study of Effects of Telitacicept vs Cyclophosphamide on Lupus Realted Interstitial Lung Disease

This trial will test whether telitacicept works better than cyclophosphamide to treat early interstitial lung disease in adults with lupus.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Drugs / interventions: Cyclophosphamide
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07077486 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) who meet the 2019 EULAR/ACR criteria for SLE, have HRCT-confirmed ILD, preserved basic lung function (FEV1/FVC ≥60% and DLCO ≥40%), and can give informed consent are ideal candidates.

Not a fit: Patients with severe liver or kidney dysfunction, significant cytopenias, pregnancy or breastfeeding, or very limited life expectancy are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, telitacicept could slow or improve lupus-related lung disease and offer an alternative to cyclophosphamide with a different safety profile.

How similar studies have performed: Telitacicept has shown benefit in lupus nephritis, but using it specifically for lupus-associated ILD is a novel application with limited prior evidence.

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.

Where this trial is running

Wuhan, Hubei

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

Study contacts

• Study coordinator: YIKAI Dr. YU, M.D

Conditions Lupus or SLE; Interstitial Lung Disease; Systemic Lupus Erythematosus