About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Telitacicept
- Placebo