NCT07077486

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-08-25
• Primary completion: 2026-10-25
• Completion: 2027-03-25
• First posted: 2025-07-22
• Last updated: 2026-01-27

Locations

1 site across 1 country: China