Actively Recruiting
Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease
Led by Tongji Hospital · Updated on 2026-01-27
100
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
W
Wuhan Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus
- Male or non-pregnant female aged 18 to 80 years
- Diagnosis of interstitial lung disease confirmed by high-resolution lung CT
- FEV1/FVC ratio of 60% or higher and diffusion capacity DLCO at least 40% of predicted
- Voluntarily agree to participate and able to understand and sign informed consent
You will not qualify if you...
- Alanine aminotransferase or aspartate aminotransferase levels more than 5 times normal
- Severe chronic kidney disease stage IV or need for dialysis with eGFR less than 30 ml/min/1.73 m2
- Hemoglobin less than 80 g/L
- White blood cell count less than 2.0 x10^9
- Platelet count less than 50 x10^9
- Pregnant or breastfeeding
- Expected to transfer to a non-study hospital within 4 weeks
- Life expectancy less than 24 weeks
- History of severe allergies
- Other serious lung diseases or significant lung abnormalities
- Currently using antitumor drugs, immunosuppressants, or immunomodulatory therapies
- Significant pulmonary hypertension or right heart failure
- Severe cardiovascular disease including recent myocardial infarction or unstable angina within 6 months
- Known risk of bleeding or requiring high-dose anticoagulant or antiplatelet therapy
- History of hemorrhagic central nervous system events within 12 months
- Active hemoptysis, hematuria, gastrointestinal bleeding, or ulcers within 3 months
- Previous or planned hematopoietic stem cell transplant or major surgery
- Unwilling or unable to use effective contraception if of childbearing potential within 28 days before or 3 months after treatment
- Alcohol or drug abuse as judged by investigator
- History of swallowing difficulties or gastrointestinal disease affecting drug use
- Contraindications to Telitacicept
- Any other condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
Y
YIKAI Dr. YU, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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