Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease

NCT ID: NCT07077486

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-25
• Study Completion Date: 2025-12-25

Brief Summary

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.

Detailed 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.

Conditions

Lupus or SLE; Interstitial Lung Disease; Systemic Lupus Erythematosus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Methylprednisolone (Corticosteroid)

Intervention Type: DRUG

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.

Immunosuppressant other than CYC

Intervention Type: DRUG

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)

Telitacicept Freeze-dried powder Injection 80mg

Intervention Type: DRUG

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.

glucocorticoids plus CYC and/or other immunosuppressants

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.

Group Type: ACTIVE_COMPARATOR

Methylprednisolone (Corticosteroid)

Intervention Type: DRUG

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.

Immunosuppressant other than CYC

Intervention Type: DRUG

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)

Cyclophosphamide (CYC)

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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)

Intervention Type: 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.

Intervention Type: DRUG

Cyclophosphamide (CYC)

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

Intervention Type: DRUG

Other Intervention Names

Methyl

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhan Central Hospital

OTHER

Sponsor Role: collaborator

Wuhan Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

YIKAI YU

the Deputy Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Countries

China

Other Identifiers

Tongji Hospital

Identifier Type: -

Identifier Source: org_study_id