Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease

Tongji Hospital

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Immunosuppressant other than CYC; Drug: Methylprednisolone (Corticosteroid); Drug: Telitacicept Freeze-dried powder Injection 80mg; Drug: Cyclophosphamide (CYC)

Study type: Interventional

Funder types: Other

Identifiers

NCT07077486

Tongji Hospital

Details and patient eligibility

About

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.

Full description

Pulmonary abnormalities are present in up to 60% of patients with SLE, and up to 10% of the patients will develop clinical interstitial lung disease (ILD). 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. The study also explores disease mechanisms in lungs and serum immunological interaction, to identify potential biomarkers for diagnosis, prognosis, and response to treatment of lupus-ILD.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

glucocorticoids and/or immunosuppressants other than CYC+ treatment with the Telitacicept group

Experimental group

Description:

Telitacicept 160mg sc qw, plus standard of care therapy including glucocorticoids and/or immunosuppressants other than CYC sush as , tacrolimus, Sirolimus, cyclosporine, leflunomide, azathioprine, motecophenol ester, hydroxychloroquine, tripterine, methotrexate and sulazazopyridine. None of the cyclophosphamide usage was included in the group.

Treatment:

Drug: Telitacicept Freeze-dried powder Injection 80mg

Drug: Methylprednisolone (Corticosteroid)

Drug: Immunosuppressant other than CYC

glucocorticoids plus CYC and/or other immunosuppressants

Active Comparator group

Description:

All patient in this group were administered with cyclophosphamide. The other immunosuppressants in this group include , tacrolimus, Sirolimus, cyclosporine, leflunomide, azathioprine, motecophenol ester, hydroxychloroquine, tripterine, methotrexate and sulazazopyridine. None of the biological agents like belimumab (Benlysta), anifrolumab (Saphnelo), telitacicept (TaiAi), tocilizumab (Actemra) and rituximab (Rituxan) was included in this group.

Treatment:

Drug: Cyclophosphamide (CYC)

Drug: Methylprednisolone (Corticosteroid)

Drug: Immunosuppressant other than CYC