Efficacy and Safety of Early Antifibrotic Therapy for Non-progressive Fibrotic Interstitial Lung Disease

You may not qualify if:

• Patients with unstable disease (IPF) assessed by investigators during screening had acute exacerbations during screening or within 3 months before randomization;
• Patients who are likely to require lung transplantation within 6 months or whose expected survival is less than 1 year as assessed by the investigators at the time of screening;
• During screening, chest HRCT indicated that the range of emphysema exceeded the range of pulmonary fibrosis (based on independent imaging evaluation results);
• Patients with airway obstruction disease (such as FEV1/FVC after bronchodilator);
• Diagnosed with IPF
• Diagnosis of PPF according to the 2022 ATS/ERS/JRS/ALAT guidelines
• Patients with other types of respiratory diseases that the investigators assessed might affect the study results;
• Patients who need to receive oxygen therapy for 15 hours or more per day;
• Resting pulse oxygen \< 90% (sea level to 1500m above sea level) or \< 85% (altitude \> 1500m) when breathing indoor air during screening;
• with other poorly controlled underlying conditions (such as NYHA Class III or IV congestive heart failure, acute myocardial infarction, unstable angina, hemorrhagic or ischemic stroke, pulmonary hypertension requiring treatment within the 6 months prior to screening), Patients assessed by the investigator as unsuitable for the study;
• Patients who had an active tuberculosis infection in the 12 months prior to screening, or had a bacterial, viral, fungal, or microbial infection requiring treatment with any clinical symptoms within the 4 weeks prior to randomization;
• Patients diagnosed with NCOV infection 1 month before screening and/or during screening (NCOV nucleic acid testing is not part of this study and can be performed on demand);
• Patients who plan to receive NCOV vaccine and other vaccines from 1 month before screening to 1 month after the last dose;
• Patients with a history of malignant tumors (except cured basal cell carcinoma of the skin and cervical carcinoma in situ) within 5 years prior to screening, or who are currently being evaluated for potential malignant tumors;
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 upper limit of normal (ULN) or total bilirubin ≥1.5× upper limit of normal (ULN);
• +9 more criteria