Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease

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.

Conditions

• Lupus or SLE
• Interstitial Lung Disease
• Systemic 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

Sponsors & Collaborators

• Wuhan Central Hospital

  collaborator OTHER

• Wuhan Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Rongchang Biopharmaceutical

  collaborator UNKNOWN

• Johns Hopkins Bloomberg School of Public Health

  collaborator OTHER

• Tongji Hospital

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-25

Primary Completion

2026-10-25

Completion

2027-03-25

Countries

• China

Study Locations