Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease

PHASE4Enrolling by invitationINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

July 25, 2025

Primary Completion Date

December 25, 2025

Study Completion Date

December 25, 2025

Conditions
Lupus or SLEInterstitial Lung DiseaseSystemic Lupus Erythematosus
Interventions
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

Trial Locations (1)

430030

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

All Listed Sponsors
collaborator

Wuhan Central Hospital

OTHER

collaborator

Wuhan Hospital of Traditional Chinese Medicine

OTHER

lead

Tongji Hospital

OTHER