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RECRUITINGPhase 4INTERVENTIONAL

Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form before the study. Who Should NOT Join This Trial: - 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: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Methylprednisolone (Corticosteroid)

In addition to conventional treatment (methyl-40mg or less /d), the treatment group also received hydroxychloroquine (100mg-200mg each time twice a day), and thalidomide (50mg-100mg each time once a day) could be added as appropriate.

DRUG

Immunosuppressant other than CYC

The control group only received conventional treatment (methyl 40 mg/d or less), and other traditional immunosuppressants (including but not limited to cyclophosphamide, tacrolimus, sirolimus, cyclosporine, leflunomide, azathioprine, motecophenol ester, hydroxychloroquine, tripterine, methotrexate and sulazazopyridine, etc.). No more than 3 types of immunosuppressant should be added during the whole treatment period, and the dose should not exceed 30% from the baseline period)

DRUG

Telitacicept Freeze-dried powder Injection 80mg

Telitacicept is a TACI-Fc fusion protein, a type of drug used to treat autoimmune diseases. It works by targeting two key proteins, BLyS and APRIL, which are involved in the development and function of B cells, a type of white blood cell. By blocking these proteins, telitacicept can help to reduce B cell activity and suppress the immune system's overactivity in autoimmune diseases. Subcutaneous injection dose ranges from 80mg once a week to 160mg once a week.

DRUG

Cyclophosphamide (CYC)

Cyclophosphamide iv injection is used for severe complications of systemic lupus erythematosus 400mg twice a week

Locations (1)

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