Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease

Not Applicable

• Conditions: Lupus or SLE; Interstitial Lung Disease; Systemic Lupus Erythematosus
• Interventions: Drug: Methylprednisolone (Corticosteroid); Drug: Immunosuppressant other than CYC; Drug: Telitacicept Freeze-dried powder Injection 80mg; Drug: Cyclophosphamide (CYC)

• Registration Number: NCT07077486
• Lead Sponsor: Tongji Hospital

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.

Study Timeline

• Study First Submitted: 2023-12-30
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22
• Study Start: 2025-07-25
• Primary Completion: 2025-12-25
• Study Completion: 2025-12-25

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
glucocorticoids and/or immunosuppressants other than CYC+ treatment with the Telitacicept group	Methylprednisolone (Corticosteroid)	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.
glucocorticoids and/or immunosuppressants other than CYC+ treatment with the Telitacicept group	Immunosuppressant other than CYC	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.
glucocorticoids and/or immunosuppressants other than CYC+ treatment with the Telitacicept group	Telitacicept Freeze-dried powder Injection 80mg	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.
glucocorticoids plus CYC and/or other immunosuppressants	Methylprednisolone (Corticosteroid)	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.
glucocorticoids plus CYC and/or other immunosuppressants	Immunosuppressant other than CYC	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.
glucocorticoids plus CYC and/or other immunosuppressants	Cyclophosphamide (CYC)	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.

Primary Outcome Measures

Name	Time	Method
Correlation between change from baseline at week 52 in forced vital capacity (FVC) [percentage (%) predicted]	At baseline and at week 24, 52	Pulmonary function measurement (FEV1/FVC% % post-treatment difference during baseline)

Secondary Outcome Measures

Name	Time	Method
Correlation between change from baseline at week 52 in diffusing capacity for carbon monoxide (DLco) [percentage (%) predicted]	At baseline and at week 24, 52	Diffuse function DLco measurement (% post-treatment difference at baseline)
Anti-double-stranded DNA antibody conversion ratio	At baseline and at week 12, 24, and 52	Anti-double-stranded DNA antibody conversion ratio
Complement C3 and C4 levels return to normal ratios	At baseline and at week 12, 24, and 52	Complement C3 and C4 levels return to normal ratios
Six minutes walking distance	At baseline and at week 12, 24, and 52	The 6-minute walk test (6MWT) is a simple, submaximal exercise test commonly used to assess functional capacity in individuals with interstitial lung disease (ILD). It measures the distance a person can walk in six minutes, and this distance (6MWD) can be correlated with disease severity and prognosis.
Changes from baseline in cumulative corticosteroid dose at week 52	At baseline and at week 52	Baseline dose was defined as the average corticosteroid dose (prednisone equivalent for all oral, IV, subcutaneous \[SC\], or intramuscular \[IM\] administrations) over the 7 days prior to, but not including, day 0; this was used to model the normalized cumulative baseline dose over 52 weeks. Actual cumulative corticosteroid dose (prednisone equivalent for all oral, IV, SC, or IM administrations) over 52 weeks was calculated
Krebs von den Lungen-6	At baseline and at week 12, 24, and 52	Krebs von den Lungen-6 (KL-6), is a biomarker primarily associated with interstitial lung disease (ILD). It's a high-molecular-weight mucin-like glycoprotein produced by type II alveolar pneumocytes. Elevated KL-6 levels in the blood can indicate the presence, severity, and progression of ILD.

Trial Locations

Locations (1)

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