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.
Voluntary informed consent provided;
Male or female aged ≥ 18 years old;
Documented diagnosis of rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM), Sjogren's syndrome (SjD) , Systemic sclerosis（SSc）,or mixed connective tissue disease (MCTD) in accordance with internationally recognized classification criteria;
Diagnosis of ILD on High Resolution Computed Tomography (HRCT) with disease extent of greater than or equal to (≥) 10% of the whole lung (WL-ILD);
Diagnosis of Interstitial lung disease other than CTD-ILD;
ILD progresses rapidly within 12 weeks before screening or during screening;
During screening, HRCT showed severe emphysema (the degree of emphysema exceeded that of ILD);
Obstructive pulmonary disease (pre-bronchodilator Forced Expiratory Volume (FEV1) /FVC <0.7);
Parallel
Telitacicept
DrugSubjects will receive Telitacicept.
Placebo
DrugThe placebo contains no active ingredients. To maintain the blind, the placebo matches the active drug in all physical aspects.
Change from Baseline in FVC(mL) at Week 52
Change from Baseline in FVC%Pred at Week 52
Change from Baseline in DLCO%Pred at Week 52
Time to ILD Progression or Death
Change from Baseline in Quantitative Interstitial Lung Disease in the Whole Lung (QILD-WL) At Week 52
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This trial is not recruiting at the moment. You can still explore other options:
