Interstitial lung disease (ILD) is a common pulmonary manifestation in chronic tissue diseases (CTD), significantly affecting patient's prognosis. The main purpose of this study is to evaluate the efficacy of telitacicept compared with placebo in slowing down the decline in lung volume in patients with interstitial lung disease associated with connective tissue disease (CTD-ILD) on the basis of standard treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
260
Subjects will receive Telitacicept.
The placebo contains no active ingredients. To maintain the blind, the placebo matches the active drug in all physical aspects.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Change from Baseline in FVC(mL) at Week 52
Time frame: Baseline and Week 52
Change from Baseline in FVC%Pred at Week 52
Time frame: Baseline and Week 52
Change from Baseline in DLCO%Pred at Week 52
Time frame: Baseline and Week 52
Time to ILD Progression or Death
Time frame: The time from Baseline to Week 52
Change from Baseline in Quantitative Interstitial Lung Disease in the Whole Lung (QILD-WL) At Week 52
Time frame: Baseline and Week 52
Change from Baseline in Quantitative Measures of Lung Fibrosis (QLF) in the Whole Lung At Week 52
Time frame: Baseline and Week 52
the proportion of subjects with a QILD-WL score reduction ≥2% at week 52
Time frame: Baseline and Week 52
The proportion of subjects who showed a ≥5% decrease in FVC (mL) from baseline at week 52;
Time frame: Baseline and Week 52
The proportion of subjects who showed a ≥10% decrease in FVC (mL) from baseline at week 52;
Time frame: Baseline and Week 52
Change from Baseline in the short form health survey(SF-36) at Week 52
Time frame: Baseline and Week 52
Change from Baseline in Patient global impression of severity(PGI-S) at Week 52
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Time frame: Baseline and Week 52
Changes from baseline in immunological markers(IgG、IgA、IgM、CD19+ B)at Week 52
Time frame: Baseline and Week 52
Incidence and severity of adverse events
Time frame: From signing of informed consent until 4 weeks after the last dose.